Paragon BioServices, Inc.

Paragon BioServices, Inc. Baltimore, MD, USA
Jul 19, 2019
Full time
Paragon Gene Therapy, now a part of Catalent, hires people with a passion to make a difference. Your expertise, coupled with our advanced technologies and collaboration with innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Paragon Gene Therapy, in Baltimore & Harmans, Maryland, provides industry-leading GMP development and manufacturing services for cutting-edge biopharmaceuticals such as recombinant viral vectors, next generation vaccines & hard-to-express recombinant proteins and oncolytic viruses. The Director, Quality Control will be responsible for overseeing and leading the Quality Control (QC) testing function in support of clinical/commercial manufacturing and ensuring compliance with applicable regulatory and industry standards for phase appropriate GMP manufacture of biological products. Key responsibilities include but are not limited to: Oversight and maintenance of Paragon's quality control testing program (including stability, reference standards and critical reagents) As a member of the Quality Control leadership team, participate in the Quality Metric review process, assess data for adverse trends, develop solutions and oversee implementation Identifies and resolves internal QC testing issues Ensures compliance with cGMP and safety requirements within the QC laboratory Schedules and provides technical oversight of testing performed internally and via external vendor labs supporting GMP manufacturing and Pre-Clinical activities and studies. Reviews and approves, SOP's, Batch Records and protocols. Participates in internal audits of GMP QC data and records, monitoring files and study files. Reviews new and executed documents for compliance to stated Paragon SOPs, formats and regulatory requirements (especially protocols, deviations, investigations, amendments, etc.) Writes and/or reviews Paragon's SOPs pertaining to Quality Control operations, STM's (standard test methods), and qualification and stability protocols to insure appropriate codification of GCP/GLP procedures Provides strategic oversight and leadership to QC Client representatives to ensure project objectives are met to a high-quality standard and according to commitments Acts as technical QC SME in support of client needs and projects and during third party inspections/audits. Responsible for supervision of designated staff to ensure effective execution of roles and responsibilities Responsible for staffing and overseeing training, professional development of employees and conducting performance reviews within group Participate in facility expansion, coordinating QA support. Outlines objectives, identifying continuous improvement initiatives, monitors progress of deliverables, and provides support to Managers and Associates Serve as team leader in QC investigations and ensure corrective and/or preventive action plans to resolve potential product quality and compliance issues are appropriately implemented Continuous reviews of all systems and procedures (SOPs) for efficiency and regulatory compliance improvements. Experience & Education: Bachelor or Master's degree in science discipline with 10 years experience in analytical and/or microbiological testing of biologic products in a GMP environment 4 years of direct management experience and demonstrated experience hiring and developing new teams Thorough knowledge of applicable GMP regulations, ICH guidelines, FDA guidelines, USP and EP, and other applicable regulatory guidances (US and EU). Strong focus on responsiveness, ability to multi-task, attention to detail, effective problem-solving skills, consistent follow-up and ability to make timely and sound decisions (Quality and Business). Must be able to prioritize. Must possess excellent communication and writing skills, patience, professionalism and ability to effectively interact with staff and management alike (transversally collaborative) across functional groups and levels. Advanced skills with MS Office applications and Adobe Acrobat Ability to analyze information and solve problems relating to Quality Control. LIMS experience preferred. Paragon Bioservices is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. #LI-EW1
Paragon BioServices, Inc. Baltimore, MD, USA
Jul 19, 2019
Full time
Paragon Gene Therapy, now a part of Catalent, hires people with a passion to make a difference. Your expertise, coupled with our advanced technologies and collaboration with innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Paragon Gene Therapy, in Baltimore & Harmans, Maryland, provides industry-leading GMP development and manufacturing services for cutting-edge biopharmaceuticals such as recombinant viral vectors, next generation vaccines & hard-to-express recombinant proteins and oncolytic viruses. The Manager of Manufacturing for the Upstream Processing group is responsible to lead a team of professional while overseeing the GMP manufacturing process, through the broad knowledge of theories and principles utilized to solve operational, as well as routine tasks in the production of bulk biologics from microbial systems for Phase I/II GMP manufacturing. Key Responsibilities include but are not limited to: Responsible for managing a team of professional production associates Oversight of upstream production operation for cell culture or microbial processes Ensures the successful technical transfer of projects from the Tech transfer group to the GMP production group Works closely with the production staff to troubleshoot process and equipment problems May create, revise, and edit SOP, SMPs, and specs as needed Actively participates in all recruiting efforts to secure, onboard and develop new staff members Facilitates GMP and Safety training of GMP staff, with a focus on cross-training and continuous improve and production records Generates operational protocol(s) and production records Works closely with senior management to initiate new production projects and assists in developing processes/techniques to meet contract objectives Will overview PD materials, equipment, methods for GMP compliance and scalability Expands the technical capabilities of the GMP Group Effectively communicates results of departmental work through team discussions and documentation Other duties as assigned Interacts with clients on presentations and project results; will also work closely with clients during initial and subsequent manufacturing campaigns Recommends equipment, supply purchases within the production areas Skills & Behaviors: Has considerable knowledge/expertise relevant to fundamental lab technologies, particularly focused on protein expression, isolation and analysis Has excellent understanding and knowledge of microbial fermentation, centrifugation, operations of reactors and TFF processes OR Have excellent understanding and knowledge of cell culture techniques and processes, experienced in using disposable single-use bioreactors (WAVES, Xcellerex) Has demonstrated track record of managing hands-on cGMP manufacturing operations Experience and a thorough understanding of coordinating manufacturing activities with other departments (QA, QC) to maintain internal and project schedules Ability to produce successful results in a fast-paced environment, under minimal supervision while leading a team of professional production associates Creative individual with excellent troubleshooting skills as they relate to scientific and engineering principles Experience & Education: B.S. in Engineering or Life Science discipline and 8+ years of GMP biologic manufacturing experience OR M.S. in Engineering in a Life Science discipline plus 6+ years of GMP biologic manufacturing experience. Some or all of this experience should be in upstream processing. Microbial: Experience with microbial (bacteria, yeast) production & fermentation processes to produce bulk biologics (proteins, polysaccharides, antibodies, etc.) OR Cell Culture: cell culture techniques and processes, experienced in using disposable single-use bioreactors (WAVES, Xcellerex) required Minimum of 3 years of leadership experience required Paragon Bioservices is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. #LI-EW1
Paragon BioServices, Inc. Harmans, Severn, MD 21077, USA
Jul 19, 2019
Full time
Paragon Gene Therapy, now a part of Catalent, hires people with a passion to make a difference. Your expertise, coupled with our advanced technologies and collaboration with innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Paragon Gene Therapy, in Baltimore & Harmans, Maryland, provides industry-leading GMP development and manufacturing services for cutting-edge biopharmaceuticals such as recombinant viral vectors, next generation vaccines & hard-to-express recombinant proteins and oncolytic viruses. Quality Associate II or III (QA Operations) is responsible to provide Quality Assurance support real-time for GMP Manufacturing of master/working cell banks, biological bulk drug substance and finished drug product to be used for human consumption. Responsibilities include providing QA on the Floor oversight of manufacturing including observing critical processes and performing AQL visual inspection, executed GMP documentation review and supporting other QA functions as needed. Continuously monitor systems and procedures to ensure compliance with applicable regulatory and industry standards, quality improvements, and efficiency for phase appropriate GMP manufacture of biological products. This position will work either 2nd or 3rd shift. Key Responsibilities include, but are not limited to: Performs QA On-the-Floor activities supporting client projects, including room release, auditing critical processes, reviewing documentation in real time, and resolving issues that occur during manufacturing. Perform audits of manufacturing and support areas, including in-process batch record review for adherence to internal procedures and Good Documentation Practices Review executed Manufacturing Batch Records and supporting documentation for completeness, accuracy and compliance. Support the evaluation and lot disposition of intermediates, finish bulk drug substance and drug product. Act as first responder for on the floor quality issues in a timely manner, documentation of all events/investigations and required immediate corrective actions. Participates in root cause analysis using methodologies, such as: fishbone, 5 whys, comparative analysis, etc. Act as QA reviewer for deviations and CAPA issuance; with limited approval authority as designated by QA Management. Also perform Acceptable Quality Limit (AQL) visual inspection of drug product Participate in SOP revision as it pertains to process improvements. Participate in site quality and process improvement initiatives. Represent QA on project teams and represent QA perspective as necessary. Guides personnel indirectly and directly involved in GMP operations pertaining to cGMP compliance, internal procedures, regulatory requirements and industry best practices. Education & Experience: B.S. in a Life Sciences discipline QA Associate II - 3 years' experience within the biologic, biopharmaceutical, or regulated pharmaceutical industry with 2 years experience in Quality Assurance function with on the floor responsibilities QA Associate III - 6 years' experience within the biologic, biopharmaceutical, or regulated pharmaceutical industry with 3 years experience in Quality Assurance function with on the floor responsibilities We will consider experience as a substitute for higher education. A High School Diploma/GED is a basic requirement in these situations. Familiarity with Good Manufacturing Practices (GMPs), 21 CFR 210/211/600s, USP and ICH Guidelines Have the knowledge, and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks Exposure to Lean Operational Excellence highly desirable Paragon Bioservices is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. #LI-EW1
Paragon BioServices, Inc. Harmans, Severn, MD 21077, USA
Jul 19, 2019
Full time
Paragon Gene Therapy, now a part of Catalent, hires people with a passion to make a difference. Your expertise, coupled with our advanced technologies and collaboration with innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Paragon Gene Therapy, in Baltimore & Harmans, Maryland, provides industry-leading GMP development and manufacturing services for cutting-edge biopharmaceuticals such as recombinant viral vectors, next generation vaccines & hard-to-express recombinant proteins and oncolytic viruses. This role is responsible for serving as a quality lead for Client Projects from start to finish for GMP Manufacturing of master/working cell banks, biological bulk drug substance and finished drug product to be used for human consumption. The Client QA contact serves as the dedicated Client QA Representative and liaisons with the Client and other Paragon functions including Project Management, Process Development, Technology Transfer, Manufacturing, Quality Control and other functions within the Quality Assurance unit. This position has the responsibility and authority to review and disposition GMP batches. Responsible for being involved in and providing disposition for failure investigations. Drive continuous quality improvement through communication/training, waste reduction, and mistake-proofing. Responsibilities include providing QA input to technology transfer documents, specifications, master/executed batch records, change requests, deviations and investigations. Shift work and/or weekend work may be required at times. This is a second or third shift position Key Responsibilities: Provides dedicated QA support to client projects and quality oversight of GMP operations for the manufacture of master/working cell banks, bulk drug substance and/or final drug product. Primary QA contact during client project lifecycle. Responsible for review and approval of master documents supporting the manufacture of products. Oversees the coordination and review of executed manufacturing documents, including delivery of such documents to clients. Supports and/or leads client on-site audits and participates in on-site technical visits. Facilitates resolution to quality issues and interfaces with the client to gain concurrence. Ensures that non-conformances are properly investigated and documented. Act as first responder and approval authority for quality issues and actively pursue timely, compliant closure and documentation of all events and investigations and required immediate corrective actions. Strong knowledge base with Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, biological regulations per 21 CFR Parts 600s, the USP AND ICH Guidelines. EU GMPs a plus. Knowledgeable and/or exposure to biological manufacturing processes including microbial and cell culture cell banking, fermentation/cell culture, purification and/or fill/finish. Ability to function well under pressure in a changing environment. Creative individual with excellent analytical, problem solving, and decision-making skills. Ability to quickly learn new and novel manufacturing processes supporting new clients. Able to work in a team setting and independently under minimum supervision. Requires the ability to produce results in a fast-paced environment to meet client deadlines. Able to effectively interpret new and existing global regulations Experience & Education: Minimum of a B.S. in a Life Sciences discipline 6-8 years' experience in a Quality Assurance role under GMP compliance supporting biologic products Have the knowledge, and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks We will consider experience as a substitute for higher education. A High School Diploma/GED is a basic requirement in these situations. Familiarity with Good Manufacturing Practices (GMPs), 21 CFR 210/211/600s, USP and ICH Guidelines Paragon Bioservices is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. #LI-EW1
Paragon BioServices, Inc. Baltimore, MD, USA
Jul 19, 2019
Full time
Paragon Gene Therapy, now a part of Catalent, hires people with a passion to make a difference. Your expertise, coupled with our advanced technologies and collaboration with innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Paragon Gene Therapy, in Baltimore & Harmans, Maryland, provides industry-leading GMP development and manufacturing services for cutting-edge biopharmaceuticals such as recombinant viral vectors, next generation vaccines & hard-to-express recombinant proteins and oncolytic viruses. The Director, Quality Control will be responsible for overseeing and leading the Quality Control (QC) testing function in support of clinical/commercial manufacturing and ensuring compliance with applicable regulatory and industry standards for phase appropriate GMP manufacture of biological products. Key responsibilities include but are not limited to: Oversight and maintenance of Paragon's quality control testing program (including stability, reference standards and critical reagents) As a member of the Quality Control leadership team, participate in the Quality Metric review process, assess data for adverse trends, develop solutions and oversee implementation Identifies and resolves internal QC testing issues Ensures compliance with cGMP and safety requirements within the QC laboratory Schedules and provides technical oversight of testing performed internally and via external vendor labs supporting GMP manufacturing and Pre-Clinical activities and studies. Reviews and approves, SOP's, Batch Records and protocols. Participates in internal audits of GMP QC data and records, monitoring files and study files. Reviews new and executed documents for compliance to stated Paragon SOPs, formats and regulatory requirements (especially protocols, deviations, investigations, amendments, etc.) Writes and/or reviews Paragon's SOPs pertaining to Quality Control operations, STM's (standard test methods), and qualification and stability protocols to insure appropriate codification of GCP/GLP procedures Provides strategic oversight and leadership to QC Client representatives to ensure project objectives are met to a high-quality standard and according to commitments Acts as technical QC SME in support of client needs and projects and during third party inspections/audits. Responsible for supervision of designated staff to ensure effective execution of roles and responsibilities Responsible for staffing and overseeing training, professional development of employees and conducting performance reviews within group Participate in facility expansion, coordinating QA support. Outlines objectives, identifying continuous improvement initiatives, monitors progress of deliverables, and provides support to Managers and Associates Serve as team leader in QC investigations and ensure corrective and/or preventive action plans to resolve potential product quality and compliance issues are appropriately implemented Continuous reviews of all systems and procedures (SOPs) for efficiency and regulatory compliance improvements. Experience & Education: Bachelor or Master's degree in science discipline with 10 years experience in analytical and/or microbiological testing of biologic products in a GMP environment 4 years of direct management experience and demonstrated experience hiring and developing new teams Thorough knowledge of applicable GMP regulations, ICH guidelines, FDA guidelines, USP and EP, and other applicable regulatory guidances (US and EU). Strong focus on responsiveness, ability to multi-task, attention to detail, effective problem-solving skills, consistent follow-up and ability to make timely and sound decisions (Quality and Business). Must be able to prioritize. Must possess excellent communication and writing skills, patience, professionalism and ability to effectively interact with staff and management alike (transversally collaborative) across functional groups and levels. Advanced skills with MS Office applications and Adobe Acrobat Ability to analyze information and solve problems relating to Quality Control. LIMS experience preferred. Paragon Bioservices is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. #LI-EW1
Paragon BioServices, Inc. Baltimore, MD, USA
Jul 19, 2019
Full time
Paragon Gene Therapy, now a part of Catalent, hires people with a passion to make a difference. Your expertise, coupled with our advanced technologies and collaboration with innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Paragon Gene Therapy, in Baltimore & Harmans, Maryland, provides industry-leading GMP development and manufacturing services for cutting-edge biopharmaceuticals such as recombinant viral vectors, next generation vaccines & hard-to-express recombinant proteins and oncolytic viruses. This role is responsible for serving as a quality lead for Client Projects from start to finish for GMP Manufacturing of master/working cell banks, biological bulk drug substance and finished drug product to be used for human consumption. The Client QA contact serves as the dedicated Client QA Representative and liaisons with the Client and other Paragon functions including Project Management, Process Development, Technology Transfer, Manufacturing, Quality Control and other functions within the Quality Assurance unit. This position has the responsibility and authority to review and disposition GMP batches. Responsible for being involved in and providing disposition for failure investigations. Drive continuous quality improvement through communication/training, waste reduction, and mistake-proofing. Responsibilities include providing QA input to technology transfer documents, specifications, master/executed batch records, change requests, deviations and investigations. Shift work and/or weekend work may be required at times. This is a second or third shift position Key Responsibilities: Provides dedicated QA support to client projects and quality oversight of GMP operations for the manufacture of master/working cell banks, bulk drug substance and/or final drug product. Primary QA contact during client project lifecycle. Responsible for review and approval of master documents supporting the manufacture of products. Oversees the coordination and review of executed manufacturing documents, including delivery of such documents to clients. Supports and/or leads client on-site audits and participates in on-site technical visits. Facilitates resolution to quality issues and interfaces with the client to gain concurrence. Ensures that non-conformances are properly investigated and documented. Act as first responder and approval authority for quality issues and actively pursue timely, compliant closure and documentation of all events and investigations and required immediate corrective actions. Strong knowledge base with Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, biological regulations per 21 CFR Parts 600s, the USP AND ICH Guidelines. EU GMPs a plus. Knowledgeable and/or exposure to biological manufacturing processes including microbial and cell culture cell banking, fermentation/cell culture, purification and/or fill/finish. Ability to function well under pressure in a changing environment. Creative individual with excellent analytical, problem solving, and decision-making skills. Ability to quickly learn new and novel manufacturing processes supporting new clients. Able to work in a team setting and independently under minimum supervision. Requires the ability to produce results in a fast-paced environment to meet client deadlines. Able to effectively interpret new and existing global regulations Experience & Education: Minimum of a B.S. in a Life Sciences discipline 6-8 years' experience in a Quality Assurance role under GMP compliance supporting biologic products Have the knowledge, and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks We will consider experience as a substitute for higher education. A High School Diploma/GED is a basic requirement in these situations. Familiarity with Good Manufacturing Practices (GMPs), 21 CFR 210/211/600s, USP and ICH Guidelines Paragon Bioservices is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. #LI-EW1
Paragon BioServices, Inc. Baltimore, MD, USA
Jul 19, 2019
Full time
Paragon Gene Therapy, now a part of Catalent, hires people with a passion to make a difference. Your expertise, coupled with our advanced technologies and collaboration with innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Paragon Gene Therapy, in Baltimore & Harmans, Maryland, provides industry-leading GMP development and manufacturing services for cutting-edge biopharmaceuticals such as recombinant viral vectors, next generation vaccines & hard-to-express recombinant proteins and oncolytic viruses. Quality Associate II or III (QA Operations) is responsible to provide Quality Assurance support real-time for GMP Manufacturing of master/working cell banks, biological bulk drug substance and finished drug product to be used for human consumption. Responsibilities include providing QA on the Floor oversight of manufacturing including observing critical processes and performing AQL visual inspection, executed GMP documentation review and supporting other QA functions as needed. Continuously monitor systems and procedures to ensure compliance with applicable regulatory and industry standards, quality improvements, and efficiency for phase appropriate GMP manufacture of biological products. Key Responsibilities include, but are not limited to: Performs QA On-the-Floor activities supporting client projects, including room release, auditing critical processes, reviewing documentation in real time, and resolving issues that occur during manufacturing. Perform audits of manufacturing and support areas, including in-process batch record review for adherence to internal procedures and Good Documentation Practices Review executed Manufacturing Batch Records and supporting documentation for completeness, accuracy and compliance. Support the evaluation and lot disposition of intermediates, finish bulk drug substance and drug product. Act as first responder for on the floor quality issues in a timely manner, documentation of all events/investigations and required immediate corrective actions. Participates in root cause analysis using methodologies, such as: fishbone, 5 whys, comparative analysis, etc. Act as QA reviewer for deviations and CAPA issuance; with limited approval authority as designated by QA Management. Also perform Acceptable Quality Limit (AQL) visual inspection of drug product Participate in SOP revision as it pertains to process improvements. Participate in site quality and process improvement initiatives. Represent QA on project teams and represent QA perspective as necessary. Guides personnel indirectly and directly involved in GMP operations pertaining to cGMP compliance, internal procedures, regulatory requirements and industry best practices. Education & Experience: B.S. in a Life Sciences discipline QA Associate II - 3 years' experience within the biologic, biopharmaceutical, or regulated pharmaceutical industry with 2 years experience in Quality Assurance function with on the floor responsibilities QA Associate III - 6 years' experience within the biologic, biopharmaceutical, or regulated pharmaceutical industry with 3 years experience in Quality Assurance function with on the floor responsibilities We will consider experience as a substitute for higher education. A High School Diploma/GED is a basic requirement in these situations. Familiarity with Good Manufacturing Practices (GMPs), 21 CFR 210/211/600s, USP and ICH Guidelines Have the knowledge, and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks Exposure to Lean Operational Excellence highly desirable Paragon Bioservices is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. #LI-EW1
Paragon BioServices, Inc. Harmans, Severn, MD 21077, USA
Jul 19, 2019
Full time
Paragon Gene Therapy, now a part of Catalent, hires people with a passion to make a difference. Your expertise, coupled with our advanced technologies and collaboration with innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Paragon Gene Therapy, in Baltimore & Harmans, Maryland, provides industry-leading GMP development and manufacturing services for cutting-edge biopharmaceuticals such as recombinant viral vectors, next generation vaccines & hard-to-express recombinant proteins and oncolytic viruses. The Sr. Director of Supply Chain will oversee the supply network and associated inventories to support all client projects/programs. This individual will help develop supply plans for all phases of clinical & commercial processes requiring an in depth understanding of GMP, planning/scheduling, purchasing, inventory management and logistics. This individual will also be responsible for client interaction as necessary during the BD and partnership. This position will closely interface with Finance, Clinical Development (PD & Manufacturing), Commercial Manufacturing, Quality Assurance, Quality Control, Regulatory Affairs to ensure material is available as required, and client strategies and timelines are adhered to. Key Responsibilities include but are not limited to: Maintain budget for supply chain operations Establish and execute Supply Chain Master Plan over multiple locations in coordination with PD, Manufacturing and Quality Assurance Instrumental in the implementation of new ERP Oversee development of demand and aggregate forecasts, as appropriate, for input into planning model Ensure batch release dates are properly prioritized for manufacturing, packaging and labeling timelines based on input from Manufacturing, Regulatory and Quality Help develop and formally document supply strategies and processes including purchasing and GMP warehouse operations. On board and manage relationships with vendors, including the establishment of agreements, quotes, purchase orders and invoicing Manage inventory reconciliation and partner with Finance for financial closes Ensure supply chain compliance to GMP documentation requirements and training Help establish consistent supply strategies across client engagements and compliance with company policies, procedures and applicable regulatory authority directives and regulations Establish clear communication and tracking of strategies and scenarios for Project Teams and Senior Management Create and maintain Supply Chain related Standard Operating Procedures (SOPs) Facilitate group training involving initiatives by FDA and other applicable regulatory authorities related to Supply Chain and documentation Provide oversight for importation/exportation compliance of labeled supplies to the appropriate drug depot and subsequent shipment to the clinical sites Participate in inspection readiness efforts, ensuring Supply Chain is fully prepared for both internal and external audits Help track Supply Chain deviations and CAPA's, and work to resolve recurring problems with permanent solutions Assist in product serialization/track and trace efforts in compliance with new requirements Leverage controlled room temperature and cold chain expertise to guide selection of shippers, couriers and shipping lanes Experience & Education: Bachelor's degree in Supply Chain or other business field 12 years of experience leading Supply Chain teams in biotech/pharmaceutical industry required; Contract Manufacturing a plus 5 years in a leadership role required Experience implementing ERP systems required Proficient in cGMP's and biotech / pharmaceutical industry procedures and regulations Must have demonstrated experience with urgency and resourcefulness Paragon Bioservices is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics #LI-EW1
Paragon BioServices, Inc. Baltimore, MD, USA
Jul 18, 2019
Full time
Paragon Gene Therapy, now a part of Catalent, hires people with a passion to make a difference. Your expertise, coupled with our advanced technologies and collaboration with innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Paragon Gene Therapy, in Baltimore & Harmans, Maryland, provides industry-leading GMP development and manufacturing services for cutting-edge biopharmaceuticals such as recombinant viral vectors, next generation vaccines & hard-to-express recombinant proteins and oncolytic viruses. The Associate Scientist/Engineer I/II is actively engaged in process and product development within a dynamic team and displays strong technical knowledge, initiative, and scientific commitment, and makes significant scientific and technical contributions to downstream process development. Key Responsibilities Include, but are not limited to: Integral team member in moving projects forward toward GMP Manufacturing for clinical trials, registration, improvements of existing processes and products Participates in decision-making processes within the project team by actively engaging in scientific and technical discussions Performs work encompassing different projects and programs including: Downstream process development of recombinant protein, virus-like particle, and virus purification processes Primary recovery from cell paste or inclusion bodies of specific proteins/macromolecules Downstream processing of macromolecules expressed in mammalian cell lines, insect cells, or microbes Development and execution of purification and analytical protocols Interaction with appropriate members of upstream and analytical functional areas for purification and analysis of target molecules Interaction with appropriate members of quality for review of documentation Deploys knowledge and technical skills to independently design and execute studies Builds credibility within group by performing high quality work Expands the technical capabilities of Process Development group, by offering expertise in areas such as technology development, platform or systems development, or using a literature precedent Teaches others in their area of expertise, and assists with work being performed by other members of the Downstream Process Development group Documents and effectively communicates results of individual executed work through summary presentations, discussions with supervisor, and scientific meetings on a regular basis. Possesses considerable knowledge and expertise relating to protein purification and analysis and other fundamental lab technologies or platforms Education & Experience: AS I - Bachelor of Science in a life science or chemical engineering field plus 0-3 years experience AS or Eng II - M.S. in a life science or chemical engineering field plus 0-3 years experience OR B.S. in a life science or chemical engineering field plus 3-5 years experience with chromatography based processing methods such as Affinity, Ion Exchange, Hydrophobic Interaction, and Size Exclusion is required as is column packing. Analytical techniques: Gel Electrophoresis (SDS PAGE Gel), Western Blotting, HPLC, Bioactivity assays, Colorimetric Protein assays, and Spectroscopic Measurements required Knowledge of how GMP regulations impact process development of biologics products Demonstrated familiarity with AKTA chromatography systems and UNICORN software is strongly desired Familiarity with instrument care, maintenance, troubleshooting, and data interpretation Experience with filtration processing using Crossflow or Tangential Flow Filtration techniques is a plus Understanding of protein biochemistry (protein folding, protein degradation, aggregation, etc. Ease with document writing, data interpretation, presentation skills, and statistical analysis The ability to work in team oriented environment is essential, as this person will work closely with other members of Process Development Group, QC, GMP, and participate on multidisciplinary project teams Previous experience working in Biotechnology or Pharmaceutical industry considered a plus. Paragon Bioservices is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. #LI-EW1
Paragon BioServices, Inc. Halethorpe, MD 21227, USA
Jul 18, 2019
Full time
Paragon Gene Therapy, now a part of Catalent, hires people with a passion to make a difference. Your expertise, coupled with our advanced technologies and collaboration with innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Paragon Gene Therapy, in Baltimore & Harmans, Maryland, provides industry-leading GMP development and manufacturing services for cutting-edge biopharmaceuticals such as recombinant viral vectors, next generation vaccines & hard-to-express recombinant proteins and oncolytic viruses. This position will support Manufacturing Operations in the successful transfer and startup of clinical drug substance and drug product cGMP manufacturing operations at Paragon Bioservices. The MS&T Sr. Engineer is actively engaged in the translation of client and Paragon Process Development information for implementation of cGMP processes. The individual will serve as a subject matter expert (SME) for biologic Upstream Processes and/or Downstream Processes. Success in this position requires the ability to work hands on in a cleanroom, and the ability to collaborate in a cross-functional, fast paced environment. Key Responsibilities include, but are not limited to: Work with GMP manufacturing and Process Development in one or more of the following areas: cell culture, purification and/or fill & finish Support client projects as the MS&T Lead for tech transfer of projects from Paragon Process Development and external clients into GMP manufacturing. Author tech transfer documents, including detailed process descriptions and scale-up documents Author Master Production Records and SOPs to support GMP manufacturing projects Working closely with project management to ensure MS&T project milestones are achieved Collect and trend process data for external (client) and internal review, and for support of client needs. With support of senior staff, draft technical reports, process tech transfer summary reports, and protocols in support of Tech Transfer and cGMP activities Assist with training GMP Manufacturing staff on Client processes Serve as team leader for process and product investigations and author investigation reports Evaluate and recommend equipment for client projects Education & Experience: B.S. Chemical Engineering, Chemistry, Biology, Life Sciences or related field with 3-5 years of experience in the pharmaceutical or biotechnology industry Knowledge/expertise relevant to protein and virus manufacturing in a cGMP environment. Experience in one or more of the following manufacturing areas: cell and/or microbial culture, protein purification and fill/finish Experience in a CMO environment or in a similar client-customer based work environment a plus Paragon Bioservices is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. #LI-EW1
Paragon BioServices, Inc. Baltimore, MD, USA
Jul 18, 2019
Full time
Paragon Gene Therapy, now a part of Catalent, hires people with a passion to make a difference. Your expertise, coupled with our advanced technologies and collaboration with innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Paragon Gene Therapy, in Baltimore & Harmans, Maryland, provides industry-leading GMP development and manufacturing services for cutting-edge biopharmaceuticals such as recombinant viral vectors, next generation vaccines & hard-to-express recombinant proteins and oncolytic viruses. The Manufacturing Compliance Specialist writes, issues, maintains and follows batch records lifecycle throughout the manufacturing plant. Once documents have been created and approved, the incumbent will be responsible for tracking the lifecycle of batch records and documents to support manufacturing activities. This position also writes and reviews standard operating procedures (SOPs). Key Responsibilities include but are not limited to: Responsible for creating documentation including batch records, SOPs, logbooks, etc. that will be used throughout the manufacturing facility Adheres to internal/external guidelines, specifications, and regulatory requirements while creating and maintaining documentation Ensures that SOPs relevant to documentation (batch records, logbooks, etc.) are generated, maintained and available Tracks GMP review and production close out of batch record documentation Key contact with Quality Assurance to ensure robust and stable document flow from issuance to archiving Positively interacts with internal associates to quickly and effectively resolve issues Addresses deficiencies and ensures completion of all follow-up actions, specifically those that target process fixes to maintain consistent resolutions to all batch review issues according to GMP standards and company objectives Supports implementation of CAPAs, SOP revisions, quality improvement initiatives, operational excellence projects, etc. Develops processes for batch records including for issuing, tracking and reviewing batch records Develops and maintains metrics to track batch record turnaround time, errors and document related deviations Education / Experience: Bachelor's degree in Life Science, Chemistry or Engineering 2 years of broad cGMP production &/or quality experience, with knowledge and understanding of process, documentation requirements and activities Extensive experience with GMP documentation management for biologics Paragon Bioservices is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. #LI-EW1
Paragon BioServices, Inc. Baltimore, MD, USA
Jul 16, 2019
Full time
Paragon Gene Therapy, now a part of Catalent, hires people with a passion to make a difference. Your expertise, coupled with our advanced technologies and collaboration with innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Paragon Gene Therapy, in Baltimore & Harmans, Maryland, provides industry-leading GMP development and manufacturing services for cutting-edge biopharmaceuticals such as recombinant viral vectors, next generation vaccines & hard-to-express recombinant proteins and oncolytic viruses. The Manager of Manufacturing for the Upstream Processing group is responsible to lead a team of professional while overseeing the GMP manufacturing process, through the broad knowledge of theories and principles utilized to solve operational, as well as routine tasks in the production of bulk biologics from microbial systems for Phase I/II GMP manufacturing. Key Responsibilities include but are not limited to: Responsible for managing a team of professional production associates Oversight of upstream production operation for cell culture or microbial processes Ensures the successful technical transfer of projects from the Tech transfer group to the GMP production group Works closely with the production staff to troubleshoot process and equipment problems May create, revise, and edit SOP, SMPs, and specs as needed Actively participates in all recruiting efforts to secure, onboard and develop new staff members Facilitates GMP and Safety training of GMP staff, with a focus on cross-training and continuous improve and production records Generates operational protocol(s) and production records Works closely with senior management to initiate new production projects and assists in developing processes/techniques to meet contract objectives Will overview PD materials, equipment, methods for GMP compliance and scalability Expands the technical capabilities of the GMP Group Effectively communicates results of departmental work through team discussions and documentation Other duties as assigned Interacts with clients on presentations and project results; will also work closely with clients during initial and subsequent manufacturing campaigns Recommends equipment, supply purchases within the production areas Skills & Behaviors: Has considerable knowledge/expertise relevant to fundamental lab technologies, particularly focused on protein expression, isolation and analysis Has excellent understanding and knowledge of microbial fermentation, centrifugation, operations of reactors and TFF processes OR Have excellent understanding and knowledge of cell culture techniques and processes, experienced in using disposable single-use bioreactors (WAVES, Xcellerex) Has demonstrated track record of managing hands-on cGMP manufacturing operations Experience and a thorough understanding of coordinating manufacturing activities with other departments (QA, QC) to maintain internal and project schedules Ability to produce successful results in a fast-paced environment, under minimal supervision while leading a team of professional production associates Creative individual with excellent troubleshooting skills as they relate to scientific and engineering principles Experience & Education: B.S. in Engineering or Life Science discipline and 8+ years of GMP biologic manufacturing experience OR M.S. in Engineering in a Life Science discipline plus 6+ years of GMP biologic manufacturing experience. Some or all of this experience should be in upstream processing. Microbial: Experience with microbial (bacteria, yeast) production & fermentation processes to produce bulk biologics (proteins, polysaccharides, antibodies, etc.) OR Cell Culture: cell culture techniques and processes, experienced in using disposable single-use bioreactors (WAVES, Xcellerex) required Minimum of 3 years of leadership experience required Paragon Bioservices is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. #LI-EW1
Paragon BioServices, Inc. Baltimore, MD, USA
Jul 16, 2019
Full time
Paragon Gene Therapy, now a part of Catalent, hires people with a passion to make a difference. Your expertise, coupled with our advanced technologies and collaboration with innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Paragon Gene Therapy, in Baltimore & Harmans, Maryland, provides industry-leading GMP development and manufacturing services for cutting-edge biopharmaceuticals such as recombinant viral vectors, next generation vaccines & hard-to-express recombinant proteins and oncolytic viruses. The Manager of Manufacturing for the Downstream Processing group is responsible to lead a team of professional while overseeing the GMP manufacturing process, through the broad knowledge and application of the theories and principles utilized to solve operational, as well as routine tasks in the purification of a variety of proteins, antibodies, etc. for Phase I/II & commercial GMP manufacturing. Key Responsibilities include but are not limited to: Responsible for managing a team of professional production associates Oversight of downstream production operation including an understanding of isolating and purifying proteins from microbial and cell culture processes. Works closely with the production staff to troubleshoot process and equipment problems May create, revise, and edit SOP, SMPs, and specs as needed Actively participates in all recruiting efforts to secure, onboard and develop new staff members Facilitates GMP and Safety training of GMP staff, with a focus on cross-training and continuous improve and production records Generates operational protocol(s) and production records Works closely with senior management to initiate new production projects and assists in developing processes/techniques to meet contract objectives Will review PD materials, equipment, methods for GMP compliance and scalability Expands the technical capabilities of the GMP Group Effectively communicates results of departmental work through team discussions and documentation Interacts with clients on presentations and project results; will also work closely with clients during initial and subsequent manufacturing campaigns Recommends equipment, supply purchases within the production areas Skills & Behaviors: Has a demonstrated track record for managing (hands-on) purification operations under cGMPs. Experience and a thorough understanding of coordinating manufacturing activities with other departments (QA, QC) to maintain internal and project schedules Ability to produce successful results in a fast-paced environment, under minimal supervision while leading a team of professional production associates Creative individual with excellent troubleshooting skills as they relate to scientific and engineering principles Experience & Education: B.S. in Engineering or Science discipline and 8+ years of GMP biologic manufacturing experience OR M.S. in Engineering in a Science discipline plus 6+ years of GMP biologic manufacturing experience. Some or all of this experience should be in downstream processing. Downstream experience includes the isolation and purification of proteins, antibodies, etc., extensive experience with chromatography equipment, columns, TFF, CIP procedures and of those processes to purify bulk proteins, antibodies, etc. (HIC, IEX, Affinity). Minimum of 3 years of leadership experience required Paragon Bioservices is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. #LI-EW1
Paragon BioServices, Inc. Severn, MD, USA
Jul 16, 2019
Full time
Paragon Gene Therapy, now a part of Catalent, hires people with a passion to make a difference. Your expertise, coupled with our advanced technologies and collaboration with innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Paragon Gene Therapy, in Baltimore & Harmans, Maryland, provides industry-leading GMP development and manufacturing services for cutting-edge biopharmaceuticals such as recombinant viral vectors, next generation vaccines & hard-to-express recombinant proteins and oncolytic viruses. Hours - 4:00 PM - 12:00 AM The Team Lead, Materials Control is responsible for supporting the overall GMP materials control/warehousing operations for a GMP phase I through commercial biopharma manufacturing facility. The position will be responsible for acting as a subject matter expert (SME) in one or more supply chain activities including receiving, internal distribution, inventory management, shipping (including HAZMAT and drug product), and logistical support in an ERP driven environment. The position will be expected to cross train in areas outside of direct responsibilities to provide support across all supply chain activities. Key Responsibilities include but are not limited to: Act as SME and process owner for one or more of the supply chain related activities listed below and to be cross trained on all other areas of operation. Areas of supply chain operation: Receiving - Responsible for receipt of all goods and associated business processes including ERP data entry, generating GMP documentation, and accountability for goods delivered to a given Paragon site. Order fulfilment and distribution - preparation, staging, and transfer of custody of all inventoried items in support of manufacturing operations in a given Paragon site. Inventory Management - responsible for maintaining inventory accuracy at 99%+ levels of accuracy, including managing cycle counts, discrepancy reconciliation, completion of any compliance documentation (SOP's deviations, change controls etc.) relating to inventory across all Paragon sites. Material Logistics (both internal and client facing) - Providing support for all inter building transfers and coordination with project management in regards to transfer of client materials. Includes ownership of third party vendor interactions such as couriers, shippers, etc. ERP software activities - Supply chain related data management including SME level understanding of ERP function relating to areas listed above as well as master data that affects all supply chain areas. Shift operations - responsible for assuring continuity of supply chain activities during shift/weekend coverage acting as a point of contact for all internal customers assuring business needs are addressed. Provide guidance to and be a resource for assigned SME areas to all employees. Generates or review GMP documentation associated with assigned SME areas including deviations, SOP's, work instructions, or performance reports. Assessing areas of assigned SME operation on a continuing basis and providing recommendations for process improvement. Provide Tier one issue resolution for assigned areas of SME responsibility prior to escalation to management. Support cGMP compliance across both supply chain and broader company operations Represent assigned SME areas during audits. Other duties as assigned Skills & Technical Expertise: Has a good understanding of supply chain related operations; Experience with ERP software systems. Must have a robust understanding of compliance activities in a GMP environment including training, authoring SOP's, deviations, etc. Experience and a thorough understanding in one or more SME areas of responsibility listed above. Accuracy and thoroughness in the completion of documentation is critical. Ability to produce results in a fast-paced environment, under minimal supervision coordinating with internal team members and customers as needed. Some areas of operation require the ability to carry up to 40 lbs. Education & Experience: Bachelor degree with 2 years of materials control experience or HS Diploma/GED with 5 years 1 year of leadership Experience with electronic supply chain software Relevant certifications a plus Paragon Bioservices is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. #LI-EW1
Paragon BioServices, Inc. Harmans, Severn, MD 21077, USA
Jul 16, 2019
Full time
Paragon Gene Therapy, now a part of Catalent, hires people with a passion to make a difference. Your expertise, coupled with our advanced technologies and collaboration with innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Paragon Gene Therapy, in Baltimore & Harmans, Maryland, provides industry-leading GMP development and manufacturing services for cutting-edge biopharmaceuticals such as recombinant viral vectors, next generation vaccines & hard-to-express recombinant proteins and oncolytic viruses. Hours - 4:00 PM - 12:00 AM The Team Lead, Materials Control is responsible for supporting the overall GMP materials control/warehousing operations for a GMP phase I through commercial biopharma manufacturing facility. The position will be responsible for acting as a subject matter expert (SME) in one or more supply chain activities including receiving, internal distribution, inventory management, shipping (including HAZMAT and drug product), and logistical support in an ERP driven environment. The position will be expected to cross train in areas outside of direct responsibilities to provide support across all supply chain activities. Key Responsibilities include but are not limited to: Act as SME and process owner for one or more of the supply chain related activities listed below and to be cross trained on all other areas of operation. Areas of supply chain operation: Receiving - Responsible for receipt of all goods and associated business processes including ERP data entry, generating GMP documentation, and accountability for goods delivered to a given Paragon site. Order fulfilment and distribution - preparation, staging, and transfer of custody of all inventoried items in support of manufacturing operations in a given Paragon site. Inventory Management - responsible for maintaining inventory accuracy at 99%+ levels of accuracy, including managing cycle counts, discrepancy reconciliation, completion of any compliance documentation (SOP's deviations, change controls etc.) relating to inventory across all Paragon sites. Material Logistics (both internal and client facing) - Providing support for all inter building transfers and coordination with project management in regards to transfer of client materials. Includes ownership of third party vendor interactions such as couriers, shippers, etc. ERP software activities - Supply chain related data management including SME level understanding of ERP function relating to areas listed above as well as master data that affects all supply chain areas. Shift operations - responsible for assuring continuity of supply chain activities during shift/weekend coverage acting as a point of contact for all internal customers assuring business needs are addressed. Provide guidance to and be a resource for assigned SME areas to all employees. Generates or review GMP documentation associated with assigned SME areas including deviations, SOP's, work instructions, or performance reports. Assessing areas of assigned SME operation on a continuing basis and providing recommendations for process improvement. Provide Tier one issue resolution for assigned areas of SME responsibility prior to escalation to management. Support cGMP compliance across both supply chain and broader company operations Represent assigned SME areas during audits. Other duties as assigned Skills & Technical Expertise: Has a good understanding of supply chain related operations; Experience with ERP software systems. Must have a robust understanding of compliance activities in a GMP environment including training, authoring SOP's, deviations, etc. Experience and a thorough understanding in one or more SME areas of responsibility listed above. Accuracy and thoroughness in the completion of documentation is critical. Ability to produce results in a fast-paced environment, under minimal supervision coordinating with internal team members and customers as needed. Some areas of operation require the ability to carry up to 40 lbs. Education & Experience: Bachelor degree with 2 years of materials control experience or HS Diploma/GED with 5 years 1 year of leadership Experience with electronic supply chain software Relevant certifications a plus Paragon Bioservices is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. #LI-EW1
Paragon BioServices, Inc. Severn, MD, USA
Jul 15, 2019
Full time
Paragon Gene Therapy, now a part of Catalent, hires people with a passion to make a difference. Your expertise, coupled with our advanced technologies and collaboration with innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Paragon Gene Therapy, in Baltimore & Harmans, Maryland, provides industry-leading GMP development and manufacturing services for cutting-edge biopharmaceuticals such as recombinant viral vectors, next generation vaccines & hard-to-express recombinant proteins and oncolytic viruses. The OJT Specialist's core responsibility is to assist the Manager of On the Job Training with the implementation of GMP training for Manufacturing employees. The OJT Specialist is also responsible for developing and providing training presentations with subject matter experts on relevant topics, providing measures to ensure complete understanding/proficiency, and performing deviation investigations stemming from GMP operations. The Manufacturing Training Specialist will interact with individuals at multiple levels within all functional departments at Paragon. The goal of this role is to ensure On the Job Training and associated procedural documentation provides clear guidance for the Manufacturing staff as well as implementing process improvements based on results from deviation investigations. Key Roles & Responsibilities include but are not limited to: Training: Design, Develop and Deliver Training Utilize training standards (standards in the Paragon Training Program procedure) to develop and design robust training that will provide knowledge to transfer learning to the workplace Draft On the Job Training Curricula Draft, revise, or develop training procedure manuals, job aids, SOPs, or course material such as handouts and visual materials Develop and deliver training presentations on pertinent topics to Manufacturing groups on an as needed basis Embeds in training design and delivery GMP practices, and an explanation of WHY Possesses the knowledge of adult learning theory, training delivery and how to meet the needs of the learner Utilize metrics to establish the success or outcome of the training (# deviations, human error) Communicate with Manufacturing Management and QA teams on an ongoing basis to support site Training needs Ability to drive the behavior to follow controlled documents and create a GMP culture Be agile to meet the demands of the CDMO business and current best practices Interact with auditors to explain company training policies and materials Experience & Education: Bachelors degree and 4+ years of experience within the biologic, pharmaceutical or medical device industry with responsibilities for performing and/or developing or delivering training to colleagues OR Associates degree and 7+ years of experience within the biologic, pharmaceutical or medical device industry with responsibilities for performing and/or developing or delivering training to colleagues Familiarity with electronic systems, including Microsoft Access and Excel Excellent written and verbal communication skills Have the knowledge, and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine Manufacturing operations Train the trainer experience is preferred Paragon Bioservices is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. #LI-EW1
Paragon BioServices, Inc. Harmans, Severn, MD 21077, USA
Jul 15, 2019
Full time
Paragon Gene Therapy, now a part of Catalent, hires people with a passion to make a difference. Your expertise, coupled with our advanced technologies and collaboration with innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Paragon Gene Therapy, in Baltimore & Harmans, Maryland, provides industry-leading GMP development and manufacturing services for cutting-edge biopharmaceuticals such as recombinant viral vectors, next generation vaccines & hard-to-express recombinant proteins and oncolytic viruses. The Document Control Coordinator oversees the revision, issuance and tracking of controlled documents used to support the Phase I/II/III and commercial GMP manufacture of bulk and sterile fill biologics. Mature professional capable of working independently and in a team setting. Continually evaluate opportunities for improvement to increase efficiency while ensuring compliance to applicable regulatory requirements and standards. Requires the ability to produce results in a fast-paced environment to meet client deadlines and to effectively prioritize based on criticality. Key Responsibilities include but are not limited to: Decisions or recommendations consistently result in favorable project results and client satisfaction. Will work directly with Clients, the QA department and other Paragon departments to revise, issue and track controlled documents to meet timelines. Provide status updates and reminders when necessary. Ensures basic grammatical accuracy and completeness when revising documents. Filing, tracking and archival of GMP documentation. Conducts internal audits of Paragon systems and documents where needed to ensure compliance to applicable Paragon Policies and SOPs. Provides reports to Upper Management and Project Management regarding document status Maintains databases used for tracking various GMP documentation. Support regulatory (FDA, EMA) and client audits/inspections of Paragon. Works under general supervision to meet project goals. Compile and provide applicable metrics for periodic Management review. Support Process Development (PD) as needed. Will work closely with various departments at Paragon to resolve quality issues and offer assistance as needed. Processes, distributes, and maintains controlled documentation (i.e., SOPs, SMPs, material specification, logbooks, etc.) using a document control system. Issuance of Batch Production Records. Other duties as assigned Education & Experience: High School Diploma and 3-10 years experience with Good Manufacturing Practices (GMPs) in the pharmaceutical, biologic or medical device industries in a Document Control position, including the revision, issuance and tracking of batch records, Standard Operating Procedures (SOP), Specifications, etc. Microsoft Word and Microsoft Access experience Exposure to 21 CFR Parts 210 & 211, biotechnology, Process Development (PD) and electronic validated computer systems a plus. Paragon Bioservices is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. #LI-EW1
Paragon BioServices, Inc. Baltimore, MD, USA
Jul 15, 2019
Full time
Paragon Gene Therapy, now a part of Catalent, hires people with a passion to make a difference. Your expertise, coupled with our advanced technologies and collaboration with innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Paragon Gene Therapy, in Baltimore & Harmans, Maryland, provides industry-leading GMP development and manufacturing services for cutting-edge biopharmaceuticals such as recombinant viral vectors, next generation vaccines & hard-to-express recombinant proteins and oncolytic viruses. The Associate Scientist/Engineer I/II is actively engaged in process and product development within a dynamic team and displays strong technical knowledge, initiative, and scientific commitment, and makes significant scientific and technical contributions to downstream process development. Key Responsibilities Include, but are not limited to: Integral team member in moving projects forward toward GMP Manufacturing for clinical trials, registration, improvements of existing processes and products Participates in decision-making processes within the project team by actively engaging in scientific and technical discussions Performs work encompassing different projects and programs including: Downstream process development of recombinant protein, virus-like particle, and virus purification processes Primary recovery from cell paste or inclusion bodies of specific proteins/macromolecules Downstream processing of macromolecules expressed in mammalian cell lines, insect cells, or microbes Development and execution of purification and analytical protocols Interaction with appropriate members of upstream and analytical functional areas for purification and analysis of target molecules Interaction with appropriate members of quality for review of documentation Deploys knowledge and technical skills to independently design and execute studies Builds credibility within group by performing high quality work Expands the technical capabilities of Process Development group, by offering expertise in areas such as technology development, platform or systems development, or using a literature precedent Teaches others in their area of expertise, and assists with work being performed by other members of the Downstream Process Development group Documents and effectively communicates results of individual executed work through summary presentations, discussions with supervisor, and scientific meetings on a regular basis. Possesses considerable knowledge and expertise relating to protein purification and analysis and other fundamental lab technologies or platforms Education & Experience: AS I - Bachelor of Science in a life science or chemical engineering field plus 0-3 years experience AS or Eng II - M.S. in a life science or chemical engineering field plus 0-3 years experience OR B.S. in a life science or chemical engineering field plus 3-5 years experience with chromatography based processing methods such as Affinity, Ion Exchange, Hydrophobic Interaction, and Size Exclusion is required as is column packing. Analytical techniques: Gel Electrophoresis (SDS PAGE Gel), Western Blotting, HPLC, Bioactivity assays, Colorimetric Protein assays, and Spectroscopic Measurements required Knowledge of how GMP regulations impact process development of biologics products Demonstrated familiarity with AKTA chromatography systems and UNICORN software is strongly desired Familiarity with instrument care, maintenance, troubleshooting, and data interpretation Experience with filtration processing using Crossflow or Tangential Flow Filtration techniques is a plus Understanding of protein biochemistry (protein folding, protein degradation, aggregation, etc. Ease with document writing, data interpretation, presentation skills, and statistical analysis The ability to work in team oriented environment is essential, as this person will work closely with other members of Process Development Group, QC, GMP, and participate on multidisciplinary project teams Previous experience working in Biotechnology or Pharmaceutical industry considered a plus. Paragon Bioservices is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. #LI-EW1
Paragon BioServices, Inc. Harmans, Severn, MD 21077, USA
Jul 15, 2019
Full time
Paragon Gene Therapy, now a part of Catalent, hires people with a passion to make a difference. Your expertise, coupled with our advanced technologies and collaboration with innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Paragon Gene Therapy, in Baltimore & Harmans, Maryland, provides industry-leading GMP development and manufacturing services for cutting-edge biopharmaceuticals such as recombinant viral vectors, next generation vaccines & hard-to-express recombinant proteins and oncolytic viruses. The OJT Specialist's core responsibility is to assist the Manager of On the Job Training with the implementation of GMP training for Manufacturing employees. The OJT Specialist is also responsible for developing and providing training presentations with subject matter experts on relevant topics, providing measures to ensure complete understanding/proficiency, and performing deviation investigations stemming from GMP operations. The Manufacturing Training Specialist will interact with individuals at multiple levels within all functional departments at Paragon. The goal of this role is to ensure On the Job Training and associated procedural documentation provides clear guidance for the Manufacturing staff as well as implementing process improvements based on results from deviation investigations. Key Roles & Responsibilities include but are not limited to: Training: Design, Develop and Deliver Training Utilize training standards (standards in the Paragon Training Program procedure) to develop and design robust training that will provide knowledge to transfer learning to the workplace Draft On the Job Training Curricula Draft, revise, or develop training procedure manuals, job aids, SOPs, or course material such as handouts and visual materials Develop and deliver training presentations on pertinent topics to Manufacturing groups on an as needed basis Embeds in training design and delivery GMP practices, and an explanation of WHY Possesses the knowledge of adult learning theory, training delivery and how to meet the needs of the learner Utilize metrics to establish the success or outcome of the training (# deviations, human error) Communicate with Manufacturing Management and QA teams on an ongoing basis to support site Training needs Ability to drive the behavior to follow controlled documents and create a GMP culture Be agile to meet the demands of the CDMO business and current best practices Interact with auditors to explain company training policies and materials Experience & Education: Bachelors degree and 4+ years of experience within the biologic, pharmaceutical or medical device industry with responsibilities for performing and/or developing or delivering training to colleagues OR Associates degree and 7+ years of experience within the biologic, pharmaceutical or medical device industry with responsibilities for performing and/or developing or delivering training to colleagues Familiarity with electronic systems, including Microsoft Access and Excel Excellent written and verbal communication skills Have the knowledge, and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine Manufacturing operations Train the trainer experience is preferred Paragon Bioservices is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. #LI-EW1
Paragon BioServices, Inc. Baltimore, MD, USA
Jul 15, 2019
Full time
Paragon Gene Therapy, now a part of Catalent, hires people with a passion to make a difference. Your expertise, coupled with our advanced technologies and collaboration with innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Paragon Gene Therapy, in Baltimore & Harmans, Maryland, provides industry-leading GMP development and manufacturing services for cutting-edge biopharmaceuticals such as recombinant viral vectors, next generation vaccines & hard-to-express recombinant proteins and oncolytic viruses. The Manager/Sr. Manager of Manufacturing for the Downstream Processing group is responsible to lead a team of professional while overseeing the GMP manufacturing process, through the broad knowledge and application of the theories and principles utilized to solve operational, as well as routine tasks in the purification of a variety of proteins, antibodies, etc. for Phase I/II GMP manufacturing. Key Responsibilities include but are not limited to: Responsible for managing a team of professional production associates Oversight of downstream production operation including an understanding of isolating and purifying proteins from microbial and cell culture processes. Works closely with the production staff to troubleshoot process and equipment problems May create, revise, and edit SOP, SMPs, and specs as needed Actively participates in all recruiting efforts to secure, onboard and develop new staff members Facilitates GMP and Safety training of GMP staff, with a focus on cross-training and continuous improve and production records Generates operational protocol(s) and production records Works closely with senior management to initiate new production projects and assists in developing processes/techniques to meet contract objectives Will review PD materials, equipment, methods for GMP compliance and scalability Expands the technical capabilities of the GMP Group Effectively communicates results of departmental work through team discussions and documentation Interacts with clients on presentations and project results; will also work closely with clients during initial and subsequent manufacturing campaigns Recommends equipment, supply purchases within the production areas Skills & Behaviors: Has a demonstrated track record for managing (hands-on) purification operations under cGMPs. Experience and a thorough understanding of coordinating manufacturing activities with other departments (QA, QC) to maintain internal and project schedules Ability to produce successful results in a fast-paced environment, under minimal supervision while leading a team of professional production associates Creative individual with excellent troubleshooting skills as they relate to scientific and engineering principles Experience & Education: B.S. in Engineering or Science discipline and 8+ years of GMP biologic manufacturing experience OR M.S. in Engineering in a Science discipline plus 6+ years of GMP biologic manufacturing experience. Some or all of this experience should be in downstream processing. Downstream experience includes the isolation and purification of proteins, antibodies, etc., extensive experience with chromatography equipment, columns, TFF, CIP procedures and of those processes to purify bulk proteins, antibodies, etc. (HIC, IEX, Affinity). Minimum of 3 years of leadership experience required Paragon Bioservices is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. #LI-EW1