Paragon BioServices, Inc.

Paragon BioServices, Inc. Harmans, Severn, MD 21077, USA
May 20, 2019
Full time
Paragon Bioservices, Inc. (PBI) is a growing biopharmaceutical contract development and manufacturing organization with an internationally recognized tradition of quality and service. PBI provides process development and GMP manufacturing services for Phase I/II clinical trials to industry leaders as well as innovative start-ups utilizing novel technologies to produce state-of-the-art vaccines and therapies for people when they are most in need. As a PBI employee, you will actively contribute to the delivery of our services and products to our customers and their patients. The EHS Specialist will assist with the management of PBI Environmental Health and Safety compliance programs in accordance with all applicable Federal, State and Local regulations, and other legal requirements to help protect the health and safety of PBI employees, to protect the environment, and to minimize risks to the company. The role will also assist internal customers with their EHS needs and actively cultivate a safety and sustainability culture. This position will focus on the policies and procedures that comprise the EHS program for Facility Management including evaluation and control of safety and health hazards in the workplace, routine hazard recognition and environmental management DUTIES & RESPONSIBILITIES: Support management to continuously improve PBI Health and Safety Programs in adherence to all Federal, State and Local requirements and PBI company policies, strategies, initiatives and goals. Health and Safety Programs supported by this position may include, but are not limited to: Industrial Hygiene, NFPA 101: Life Safety Code, Fire Prevention, Emergency Evacuation, Property Conservation, Ergonomics (Lifting Safety, Warehouse Safety), Hazard Communication, and other General Safety Programs including but not limited to Hot Work, Control of Hazardous Energy, Compressed Gas Safety, Electrical Hazard Safety, Lock-Out Tag-Out, Ladder Safety, Confined Space, Facilities PPE and Respiratory Protection as necessary. Support and continuously improve PBI Environmental and Sustainability Programs in adherence to all Federal, State and Local requirements and PBI company policies, strategies, initiatives and goals. Environmental and sustainability programs supported by this position may include but are not limited to: Energy Conservation, Wastewater Management, RCRA Hazardous Waste, Biological Waste and Water Conservation. Support and implement programs to foster a culture of safety and environmental stewardship within PBI business units. Duties may include performing safety inspections; partnering with managers, supervisors, and employees to minimize occupational health and safety risks; teaching specific safe work habits and driving a behavior-based safety program. Assist with the development, improvement, and management of EHS Management Systems for the PBI sites. Develop and implement continuous improvement concepts to better the site's safety and environmental performance. Miscellaneous EHS duties as required, including but not limited to: EHS training Maintain PBI operating permits Perform job safety analyses/risk assessments Participating on emergency response teams such as Emergency Evacuation Team. Responding to Near Misses and Incident reporting Leading member of the PBI Safety Committee Lead and participate in inspections and audits Waste water discharge and air regulatory reports Other tasks as required EDUCATION, SKILLS & TECHNICAL EXPERTISE: Bachelor's Degree from an accredited university in Occupational Safety and Health, Industrial Hygiene, Industrial Safety or related field of study. Applicants with a bachelor's degree in biology or Chemistry with appropriate relevant experience will be considered, with 2+ years of experience, OR Associate degree from an accredited university in Occupational Safety and Health, Industrial Hygiene, Industrial Safety or related field of study. Applicants with an associate degree in Biology or Chemistry with appropriate relevant experience will be considered, with 2+ years of experience. Facilities EHS program development, implementation and management experience preferred but not required. Experience in biopharmaceutical industry a plus Professional certification (CIH, CSP) a plus Knowledge of OSHA/NIOSH regulations, and other applicable Federal, State, and Local EHS regulations. Demonstrated ability to recognize, evaluate and recommend controls for workplace hazards. Ability to complete projects with a minimum of supervision. Work is performed under general direction. Participates in determining objectives of assignment. Plans schedules and arranges own activities to accomplish objectives. Work is reviewed upon completion for adequacy in meeting objectives. Able to focus, multitask, and work under pressure to meet deadlines. Excellent decision making and organization skills. Strong written and verbal communication skills Demonstrated ability to influence by example and the ability to work with all levels of the organization. Ability to work in a diverse group of employees fostering a team environment. Excellent PC skills with proficiency with MS Office (Word, Excel, PowerPoint) 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.
Paragon BioServices, Inc. Baltimore, MD, USA
May 20, 2019
Paragon Bioservices is a contract development and manufacturing organization (CDMO) whose focus is the development and manufacturing of cutting-edge biopharmaceuticals. We provide 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. Paragon's scientists, engineers, quality experts, manufacturing operators and program managers are experts working with biologics from research and process development to GMP manufacturing for clinical trials and commercial launch. This position responsible for effectively hiring, developing, coaching, counseling, managing and motivating the QC Microbiology staff. They are responsible for the timely and accurate completion of required testing of Environmental Monitoring (EM)/ Clean Utilities, raw materials, in-process and finished products. They assure compliance to GMP and company specifications as well as relevant pharmacopeia compendia. The supervisor identifies areas for continuous improvement and/or implementation of industry best practices and drive implementation in the laboratory. The supervisor keeps laboratory management informed of all departmental activities and product related events. Key Responsibilities include but are not limited to: Manages daily activities of QC Environmental Monitoring Analysts and assures that job activity deadlines are met on a timely basis. Hires and oversees the training of QC department personnel. Assures that steps are taken to maintain positive personnel morale and development. Assures execution of monitoring and testing programs to assess the quality of raw materials, components, in-process and finished goods, environmental systems/utilities systems and effectiveness of production processes. Generates new/revises Standard Operating Procedures for Environmental Monitoring and Microbiology test procedures. Ensures that raw materials, components, products, or monitoring results that do not meet specifications or expectations are promptly investigated. Identifies possible source and corrective action needed and evaluates the impact upon the product. Identifies adverse microbial quality trends by preparing and analyzing Environmental Monitoring summary reports. Reviews work performed by department staff for accuracy, completeness and conformance to GDP and product specifications. Mentors and develops new department personnel including training in Standard Operating Procedures and On The Job Training (OJT). Assures department is equipped with functional, calibrated equipment and necessary supplies. Investigates and resolves non-conforming test results by completing thorough Deviation, OOS/OOT, and Laboratory Investigation Reports Represents the QC Microbiology department in cross functional teams and internal/external meetings. Assumes other duties and responsibilities as assigned. Education & Experience: B.S. in a Life Sciences discipline preferably Microbiology with 8 years of experience working in a GMP Quality Control role, with 2 years of supervisory experience Experience with viable and non-viable Environment Monitoring collection instruments, techniques and qualifications/validations. Concentration of experience in implementing aseptic technique and contamination control strategies Experience with Microsoft Office Strong attention to detail Have the knowledge and ability to apply advanced scientific and regulatory principles to solve operational, as well as routine quality tasks. 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. Harmans, Severn, MD 21077, USA
May 20, 2019
Paragon Bioservices, Inc. (PBI) is a growing Biotech Contract Development and Manufacturing Organization (CDMO) with an internationally recognized tradition of quality and service. Paragon Bioservices provides process development and GMP manufacturing services for Phase I/II clinical trials to industry leaders as well as innovative start-ups utilizing novel technologies to produce state-of-the-art vaccines and therapies for people when they are most in need. As a PBI employee, you will actively contribute to the delivery of our services and products to our customers and their patients. The Quality Control Analyst III responsible for routine QC raw material, in-process and product testing and stability testing as well as testing of cleaning and validation samples to support Phase I/II/III and Commercial GMP manufacturing. The QC analyst must demonstrate technical knowledge, be familiar with basic scientific/regulatory principles, possess initiative, and maintain a strong commitment to scientific excellence. Key Responsibilities include but are not limited to: Has considerable knowledge/expertise relevant to QC analytical methods used for protein chemistry and molecular biology. Knowledge/expertise should be practical and focused on lab-related activities: Perform assays such as ELISA, DNA/RNA extraction and gel electrophoresis, qPCR, RT-PCR, HPLC and Capillary Electrophoresis Generate internal and external documents such as assay protocols, summary reports, and SOPs Work with clients during initial and subsequent transfer of assays and analytical methods to support GMP manufacturing campaigns Provide instrumentation care, maintenance, troubleshooting, and data interpretation Work under general supervision to meet project goals Work closely with Manufacturing and Quality Assurance staff to resolve quality issues with regard to the facility and products manufactured Document writing (laboratory investigations, out of specifications, deviations, CAPAs), data interpretation/presentation, statistical analysis, and trending Experience & Education: B.S. in a Life Sciences discipline and 4 years of relevant experience working in a GMP QC laboratory performing assays such as ELISA, DNA/RNA extraction and gel electrophoresis, qPCR, RT-PCR, HPLC and Capillary Electrophoresis Experience in writing SOPs and test methods as well as method qualification/validation documentation Broad experience with biochemistry and biological assay support, as well as generating/reviewing the documentation that supports such work Possesses the knowledge and ability to apply basic scientific and regulatory principles to solve operational, as well as routine quality tasks Ability to succeed in a team-oriented environment under very dynamic conditions 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
May 20, 2019
Paragon Bioservices is a contract development and manufacturing organization (CDMO) whose focus is the development and manufacturing of cutting-edge biopharmaceuticals. We provide 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. Paragon's scientists, engineers, quality experts, manufacturing operators and program managers are experts working with biologics from research and process development to GMP manufacturing for clinical trials and commercial launch. The Associate Scientist/Engineer 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: 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
May 20, 2019
Paragon Bioservices, Inc. (PBI) is a growing Biotech Contract Development and Manufacturing Organization (CDMO) with an internationally recognized tradition of quality and service. Paragon Bioservices provides process development and GMP manufacturing services for Phase I/II clinical trials to industry leaders as well as innovative start-ups utilizing novel technologies to produce state-of-the-art vaccines and therapies for people when they are most in need. As a PBI employee, you will actively contribute to the delivery of our services and products to our customers and their patients. The Manager, Facilities and Engineering will be responsible for the overall facilities needs for both GMP and non GMP areas including Manufacturing, Product Development and Administrative buildings both existing and under design. Specifically, managing and executing the preventive maintenance, repairs, installation and calibrations on building utilities, HVAC, control systems, water and steam systems and process equipment (some within GMP compliance). The position directs the day-to-day activities of the maintenance & calibration teams to include training, security, pest control, maintenance, calibration, janitorial activities and associated contractors. Key Responsibilities include, but are not limited to: Ensure that all facility utilities are 100% operational and maintained in accordance with cGMP SOP's, maintaining departmental industry compliance in support of GMP Manufacturing, Product Development administrative and laboratory activities Lead, coach and mentor existing and new team members in both the maintenance and metrology teams supporting all shifts Set Expectations and ensure all contractors are compliance and meeting expectations regarding contracted obligations, training and enforce safety awareness and practices Recommend solutions and implements appropriate corrective actions for major and complex maintenance issues Administrator of Blue Mountain calibration and maintenance software program Startup and shutdown facility systems and upgrade associated utilities as required for new equipment installations Manage plans for calibration and preventative maintenance of all GMP equipment, lab equipment, and utilities such as clean steam, WFI, RO/DI water, boilers, compressed gases, HVAC systems, electrical, life safety, and emergency power system (UPS) Responsible for monitoring and responding to remote Critical Equipment Monitoring System notifications and take appropriate action per approved SOP's All Facility team are on call 24-7 Participate in client and regulatory audits, audit responses and follow up corrective actions when required Generate SOP's, deviations, and change control as required for related facilities systems Revise SOP's as required for updated systems and procedures Manage facility support contractors, including security. pest control, waste management fire systems, and landscaping Maintain up to date records for all state, federal, and local licenses and inspections Manage space planning, storage areas, and furniture purchasing/installations Education & Experience: HS Diploma/GED and 12 years experience in a Maintenance or Facilities role with some or all of that experience under GMP compliance Associates Degree and 10 years experience Bachelor Degree or more and 8 years experience Hands on maintenance/facilities experience with mechanical, electrical, HVAC, water systems & compressed gas systems Direct leadership experience across multiple shifts Experience writing, reviewing, editing SOP's and other compliance documentation 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.
Paragon BioServices, Inc. Baltimore, MD, USA
May 19, 2019
Paragon Bioservices is a contract development and manufacturing organization (CDMO) whose focus is the development and manufacturing of cutting-edge biopharmaceuticals. We provide 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. Paragon's scientists, engineers, quality experts, manufacturing operators and program managers are experts working with biologics from research and process development to GMP manufacturing for clinical trials and commercial launch. Be the trusted agent and right hand to accomplished biotech leaders building the next industry leader. We are looking for business people familiar with HR, not HR people familiar with business. As a strategic consultant, the HR Business Partner (HRBP) builds and sustains the Paragon organization by developing a senior advisory relationship with business unit leaders in order to facilitate the accomplishment of their critical business objectives. It will be the HRBP's responsibility to thoroughly understand their client's business, including their priorities, challenges and customers through which they will leverage sound business judgement and HR input. Key Responsibilities include but are not limited to: Increase the business leader's effectiveness in developing their people and creating a high performing culture by partnering on all aspects of leadership development, people management, and employee engagement. Partner closely with business leaders to develop and implement practical solutions in support of business objectives, providing thought leadership and proactive solutions. Where necessary, incumbent will implement HR related initiatives (i.e., talent management and succession planning, talent review, strategic workforce planning, performance management, org design, etc.) that facilitate the business meeting its objectives. Proactively work with business leaders to identify and troubleshoot organizational issues that could impede positive productivity, achievement of organizational goals, and employee engagement. Champions career development and recognition initiatives while resolving employee relations issues in concert with business leader direction. Analyzes organizational issues to their root cause while identifying trends requiring changes in policies and practices. Achieves and maintains a proficient level of business literacy regarding the financial, operational and commercial positions of the business. Ensures compliance with internal and external (legal) entities that govern HR processes/practices. Education & Experience: Bachelor degree required; business field preferred Advanced degree preferred Minimum of 8 to 10 years business side and human resource experience. Ideal candidate will have competencies in people management, program management and/or exposure to non-HR functional areas. Strong business acumen essential - Must have a true business orientation and perspective indicative of an ability to provide strategic insight and analysis to business issues outside of the HR function. Be able to provide a solution perspective, not just an HR perspective. Maturity and professional demeanor to advise, challenge and partner with senior executives in order to quickly become a trusted agent within the business. Proven leadership abilities to effectively champion change, manage conflict and influence throughout every level of the organization. Knowledge and experience in multiple HR disciplines (i.e. organizational diagnosis, employee engagement, leadership development; strategic staffing; performance management; talent management; workforce effectiveness; succession planning; organizational development, design & effectiveness; legal compliance; rewards and recognition, etc.). 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
May 18, 2019
Paragon Bioservices, Inc. (PBI) is a growing bio pharmaceutical contract development and manufacturing organization with an internationally recognized tradition of quality and service. PBI provides process development and GMP manufacturing services for Phase I/II clinical trials to industry leaders as well as innovative start-ups utilizing novel technologies to produce state-of-the-art vaccines and therapies for people when they are most in need. As a PBI employee, you will actively contribute to the delivery of our services and products to our customers and their patients. The Process Validation Engineer is responsible for qualifying cGMP manufacturing equipment cleaning, process validation, and aseptic/sterile processes. Key Responsibilities include but are not limited to: Generates qualification protocol(s), for various processes in the facility. Oversees the timely completion of all validation documentation, including coordination of contractor activities. Works closely with Manufacturing, QA/QC and Facilities staff in the execution of validation activities, as applicable. May interact with clients on process requirements. Support the maintenance of the validation program for process qualification, aseptic processing, and cleaning verification activities. Design/execute studies to determine clean and dirty hold times for all multi-use product contact manufacturing equipment. Support changes through the provision of necessary validation documentation and change control activities. Develop and support continuous improvement initiatives for the validation of cleaning, aseptic, and manufacturing processes Provide hands on support to the manufacturing areas as required to assist in problem solving and long term changes that provide product/process improvements in relation to process failures. Collect and analyze data to make data driven recommendations/decisions Participate in process failure investigations. Build and maintain successful cross-functional relationships with internal customers such as Manufacturing, Process Development, Analytical, Quality and Facilities Engineering. Maintain up to date knowledge of validation requirements, practices, and procedures and instruct other members of the site participating in validation studies. Ability and willingness to work in a fast-paced environment Performs duties related to Corrective and Preventative Action (CAPA) plans, deviations and change control. Participates in gap analysis, risk analysis and FMEA activities. Experience & Education: B.S. in Life Science field required. Chemical / BioChemical or Biomedical Engineering preferred. Minimum of 2 years of experience process validation supporting biologic products in a GMP environment required Experience with executing a successful PPQ campaign is highly desirable Experience in designing and/or performing Aseptic Process Simulations is highly desirable Experience with design and execution of cleaning validation / verification studies is 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
May 17, 2019
Full time
Paragon Bioservices, Inc. (PBI) is a growing Biotech Contract Development and Manufacturing Organization (CDMO) with an internationally recognized tradition of quality and service. Paragon Bioservices provides process development and GMP manufacturing services for Phase I/II clinical trials to industry leaders as well as innovative start-ups utilizing novel technologies to produce state-of-the-art vaccines and therapies for people when they are most in need. As a PBI employee, you will actively contribute to the delivery of our services and products to our customers and their patients. The Manager, Central Services is responsible for leading a team of professionals 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 and preparation of buffer and media. Key Responsibilities Include, but are not limited to: • Manage buffer and media weigh/dispense/production suites, clean/sterile assembly preparation, raw material sampling and dispensing. Drive the design, acquisition and implementation and of new technologies for buffer and media preparation. Assist with the transfer of new buffers and media formulations working with GMP Operations and Development laboratory personnel. Oversight of other areas within the facility may be added at the company's discretion. • Provide general supervision for cGMP suite cleaning and waste removal, stocking of consumables, and movement of raw materials and solutions within the cGMP suites. • Provide direct supervision, training, and hands-on support of production staff in the operation of equipment to support preclinical, clinical phase, and commercial launch batches of all materials. Coordinate and supervise department change-over activities. Serve as the equipment and suite owner to coordinate routine suite and equipment maintenance, calibration, and validation with appropriate internal departments. • Coordinate the preparation/revision of master batch records, SOPs, and review/close-out all cGMP documents, including equipment and process deviations for each campaign. • Assist in troubleshooting equipment issues and batch/material related deviations. Provide timely reporting, investigation, and resolution of manufacturing process/product deviations, change controls, and commitments. • Ensure adherence of operations to cGMP guidelines as well as industry safety standards and OSHA guidelines. • Interact cross-functionally with Upstream and Downstream Operations, Facilities, Quality Assurance, Quality Control, MS&T and other internal and external functions to support successful batch production. • Recruit, train, and develop staff supporting operations. Ensure staff are trained in cGMPs, process specific knowledge, equipment operation, and relevant regulations. Education & Experience: • Minimum of 5-8 years in a multi-discipline cGMP production environment, initiating, scheduling, and managing product manufacturing functions. • Knowledgeable in operation of washers, sterilizers, and buffer/media single use solution prep equipment. • Knowledgeable in cGMP equipment validation, trouble shooting, and maintenance. • Ability to identify, investigate, and solve process, product and equipment problems. • Strong working knowledge of USP and EU. • Excellent written and communication skills. • Excellent interpersonal skills. • Team player who can excel in a "hands-on" entrepreneurial environment. • Previous supervisory experience. • Ability to train and develop subordinate technical staff. • Fitness for the use of chemical safety respirators for solution handling 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.
Paragon BioServices, Inc. Baltimore, MD, USA
May 17, 2019
Full time
Paragon Bioservices, Inc. (PBI) is a growing Biotech Contract Development and Manufacturing Organization (CDMO) with an internationally recognized tradition of quality and service. Paragon Bioservices provides process development and GMP manufacturing services for Phase I/II clinical trials to industry leaders as well as innovative start-ups utilizing novel technologies to produce state-of-the-art vaccines and therapies for people when they are most in need. As a PBI employee, you will actively contribute to the delivery of our services and products to our customers and their patients. This role is responsible for the coordination and delivery of raw material test samples internally and to Contract Laboratories. Key responsibilities include but are not limited to: Sampling of raw materials according to established specifications Coordinate and delivery of samples to QC lab for internal testing of raw materials. Sending out of raw material samples to Contract Testing Laboratories (CTL). Follows up with CTLs on testing and turnaround times to ensure testing deadlines are met. Review of test data from CTLs. Includes interpretation of test results according to specifications, USP and EP. Works closely with Quality Control and Material Control for coordination of raw materials for sampling and testing. May also interact with Project Managers on raw material coordination. Effectively communicates updates and results from CTLs. Flexibility in following unique campaign requirements that may include off-hour and weekend work Establishes and revises material specifications in accordance with current compendial chapters/monographs and updates as well as client specific requests Ability to produce results in a fast-paced environment to meet client deadlines under minimal supervision Experience with CTLs and coordination of sample testing. Able to work in a team setting and independently under minimum supervision Experience with MS Excel and Word for tracking of testing. Document writing, data interpretation, presentation, statistical analysis and trending a plus Education & Experience: B.S. or A.S. in a Life Sciences discipline preferred and 2-4 years of relevant experience working in a cGMP environment Experience working in cGMP Quality Control Experience with raw material testing and set up of raw material programs Experience with USP and EP Experience with Microsoft Excel and Microsoft Word Experience working in a Phase III/Commercial Manufacturing setting preferred Strong attention to detail and strong organizational skills Strong verbal communication skills with outside contract laboratories Familiarity with Good Manufacturing Practices (cGMP's) Have the knowledge and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks Ability to succeed in a team-oriented environment under very dynamic conditions 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
May 17, 2019
Full time
Paragon Bioservices, Inc. (PBI) is a growing Biotech Contract Development and Manufacturing Organization (CDMO) with an internationally recognized tradition of quality and service. Paragon Bioservices provides process development and GMP manufacturing services for Phase I/II clinical trials to industry leaders as well as innovative start-ups utilizing novel technologies to produce state-of-the-art vaccines and therapies for people when they are most in need. As a PBI employee, you will actively contribute to the delivery of our services and products to our customers and their patients. Key Responsibilities include but are not limited to: Sampling of raw materials according to established specifications Sample coordination and receipt from other departments for internal and external testing Scheduling of QC testing and activities Sending out of test samples to Contract Testing Laboratories (CTL) Follows up with CTLs on testing and turnaround times to ensure testing deadlines are met Trending of all CTL test results Works closely with Manufacturing, Analytical Development and Process Development for scheduling of samples submission to the QC lab. May also interact with Project Managers on sample coordination Effectively communicates updates and results from CTLs Flexibility in following unique campaign requirements that may include off-hour and weekend work Other duties as assigned Experience & Education: High School Diploma and 1-2 years of experience working in a cGMP environment required. Biologic sample coordination preferred Experience with Microsoft Excel and Microsoft Word Strong attention to detail and strong organizational skills Strong verbal communication skills with outside contract laboratories Ability to succeed in a team-oriented environment under very dynamic conditions 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
May 17, 2019
Full time
Paragon Bioservices, Inc. (PBI) is a growing Biotech Contract Development and Manufacturing Organization (CDMO) with an internationallyrecognized tradition of quality and service. Paragon Bioservices provides process development and GMP manufacturing services for Phase I/II clinical trials to industry leaders as well as innovative start-ups utilizing novel technologies to produce state-of-the-art vaccines and therapies for people when they are most in need. As a PBI employee, you will actively contribute to the delivery of our services and products to our customers and their patients. This individual is responsible for analytical method transfers and method qualifications between the Analytical Development group and Quality Control (QC). This individual will also be responsible for method validation in QC and may assist with routine testing as needed. The QC analyst must demonstrate strong technical knowledge, be familiar with advanced scientific/regulatory principles, possess initiative, and maintain a strong commitment to scientific excellence. Key Responsibilities include but are not limited to: Has considerable knowledge/expertise relevant to QC analytical methods used for protein chemistry and molecular biology. Knowledge/expertise should be practical and focused on lab-related activities: Experience with the transfer/qualification/Validation of GMP assays such as ELISA, qPCR, RT-PCR, HPLC and Capillary Electrophoresis Perform assays such as ELISA, DNA/RNA extraction and gel electrophoresis, qPCR, RT-PCR, HPLC and Capillary Electrophoresis Generate internal and external documents such as assay protocols, summary reports, and SOPs Assist with investigations related to assay performance Work on project teams developing and improving assay Work with clients during initial and subsequent transfer of assays and analytical methods to support GMP manufacturing campaigns Provide instrumentation care, maintenance, troubleshooting, and data interpretation Work under general supervision to meet project goals Work closely with Analytical Development Assurance to resolve technical issues during qualification testing/transfer Document writing (laboratory investigations, out of specifications, deviations, CAPAs), data interpretation/presentation, statistical analysis, and trending Experience & Education: Bachelor in a Life Sciences discipline and 4 or more years of experience working in a GMP QC laboratory with some or all of that time focused on the transfer & validation of QC analytical methods used for protein chemistry and molecular biology. Will consider a Master's degree in a Life Science field with 2 years of experience. Experience in writing SOPs and test methods as well as method qualification/validation documentation Broad experience with biochemistry and biological assay support, as well as generating/reviewing the documentation that supports such work Possesses the knowledge and ability to apply basic scientific and regulatory principles to solve operational, as well as routine quality tasks Ability to succeed in a team-oriented environment under very dynamic conditions 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
May 17, 2019
Full time
Paragon Bioservices, Inc. (PBI) is a growing Biotech Contract Development and Manufacturing Organization (CDMO) with an internationally recognized tradition of quality and service. Paragon Bioservices provides process development and GMP manufacturing services for Phase I/II clinical trials to industry leaders as well as innovative start-ups utilizing novel technologies to produce state-of-the-art vaccines and therapies for people when they are most in need. As a PBI employee, you will actively contribute to the delivery of our services and products to our customers and their patients. This role is responsible for supporting Quality Systems, including investigation/deviation management, CAPA tracking, and change control. This position will facilitate the compiling, trending and reporting key quality metrics for management, and other quality system 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: Supports administration for CAPA, Investigation, and Deviation systems. Includes, facilitating the closure of items with the applicable departments to ensure completion and timely resolution. Responsible for tracking and trending aspects of the Quality System and provide reports to management identifying risks and trends on a routine basis. Performs CAPA effectiveness evaluation based on quantitative and qualitative measurements. Administer the Change Control process for the site and conduct effectiveness verification for changes implemented. Maintains tracking mechanisms to support various Quality Systems elements and ensures visibility throughout the organization Continuously monitor and review systems and procedures for adherence to regulatory compliance, quality improvements, efficiency and industry best practices. Participate in compliance remediation plans and implementation. Assists with the generation and/or revision of GMP documentation such as standard operating procedures. Coordinates on-site client audits, preparation of audit materials, and ensure timely response and resolution to client observations. Assists with performing internal audits. Works cross-functionally with departments to review and improve upon Quality System metrics Participate in site quality and process improvement initiatives. Represent QA on site project teams. Other duties as assigned EDUCATION & EXPERIENCE: Minimum of a B.S. in a Life Sciences discipline 6 years' experience in a GMP environment with at least 4 of those years in a Quality/Compliance function Have the knowledge, and ability to apply basic scientific and regulatory principles to improve quality systems ASQ (American Society of Quality) or RAPS (Regulatory Affairs Professionals Society) 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
May 17, 2019
Full time
Paragon Bioservices, Inc. (PBI) is a growing biopharmaceutical contract development and manufacturing organization with an internationally recognized tradition of quality and service. PBI provides process development and GMP manufacturing services for Phase I/II clinical trials to industry leaders as well as innovative start-ups utilizing novel technologies to produce state-of-the-art vaccines and therapies for people when they are most in need. As a PBI employee, you will actively contribute to the delivery of our services and products to our customers and their patients. This role is responsible for supporting the overall GMP materials control/warehousing operations for a Phase II/II GMP biopharma manufacturing facility. The position requires practical experience and knowledge of a variety of activities such as materials receipt/quarantine/release, logistical support in a manufacturing facility, electronic inventory control and distribution/shipping of products. Hours are 4:00 PM - 12:00 AM Responsibilities include but are not limited to: Conducts reviews of GMP documentation associated with materials control (material specifications, receipt inspection forms, inventory records, item request form) Assessing the Materials Control operation on a continuing basis and providing recommendations for improvement is encouraged Generation of GMP documentation (SOPs, etc.) is expected Will participate in the receipt of all GMP materials - rectify discrepancies, matching vendors' documentation against Paragon requirements (GMP and accounting). Initiates appropriate documentation in a timely manner Will distribute materials for GMP operations following approved procedures. This includes assisting in the reconciliation of all GMP materials after client campaigns Compile and maintain inventory records Takes receipt and inventory control of Paragon generated material (cell banks, bulk protein, etc.) Assists with performing internal audits Will participate in regulatory (FDA, EMEA) and client audits/inspections of Paragon and the facility Works under general supervision to meet project goals Works closely with QA to quarantine and release all GMP materials in a timely manner Participation in the organization and cleanliness of the warehouse will be critical Assists in the training of "junior" personnel Will work closely with various departments at Paragon and aid as needed. This may include support for pre-clinical projects Working closely with various departments and aids as needed Experience & Education: High School Diploma with at least 2 years of relevant experience with warehousing operations Experience with electronic inventory control systems as well as MS Outlook and Excel Documented training (certification) of hazardous materials Mature professional capable of independent work Ability to lift and carry up to 40 lbs. is 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.
Paragon BioServices, Inc. Harmans, Severn, MD 21077, USA
May 17, 2019
Full time
Paragon Bioservices is a contract development and manufacturing organization (CDMO) whose focus is the development and manufacturing of cutting-edge biopharmaceuticals. We provide 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. Paragon's scientists, engineers, quality experts, manufacturing operators and program managers are experts working with biologics from research and process development to GMP manufacturing for clinical trials and commercial launch Hours - 4:00 PM - 12:00 AM General Description: This role 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. Shift work and/or weekend work may be required at times. Duties & Responsibilities: 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 & PREVIOUS EXPERIENCE: Bachelor level degree with 2 years or relevant experience or 5 years of relevant experience 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. Baltimore, MD, USA
May 17, 2019
Full time
Paragon Bioservices is a contract development and manufacturing organization (CDMO) whose focus is the development and manufacturing of cutting-edge biopharmaceuticals. We provide 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. Paragon's scientists, engineers, quality experts, manufacturing operators and program managers are experts working with biologics from research and process development to GMP manufacturing for clinical trials and commercial launch. This role is responsible for supporting the quality systems attributes associated with client audits, through audit preparation, hosting and backroom support. Additional responsibilities include ownership and driving of investigation/deviation, CAPA, change control, risk management, and other quality system functions, directly related to client audit. Works in a fast-paced environment supporting the quality assurance/quality control departments of a CMO for Phase I/II GMP manufacturing of biologic bulk drug substance and sterile finished drug product. Extended work and/or weekend work may be required at times. Key Responsibilities include but are not limited to: Responsible for administrating support for client audits/inspections of Paragon. Audit support may require leading back rooms, fulfilling client requests, and/or other audit supporting administrative responsibilities. Responsible for being a liaison with applicable departments to ensure their complete and timely resolution of audit items. Responsible for understanding batch documentation for applicable to client audits focused points. Maintains databases and systems used for tracking various GMP manufacturing associated audit support activities Assists with the generation and/or revision of GMP documentation such as standard operating procedures. Assists with the generation of audit report responses, technical writer for GMP systems. Works closely with manufacturing, Facilities and Quality Control staff to resolve quality issues regarding the facilities and product manufactured Work closely with other departments at Paragon and offer assistance as needed Continually evaluate systems and procedures for improvement for efficiency while ensuring compliance to applicable regulatory requirements and standards Experience & Education: B.S. in a Life Sciences discipline and 6+ years of relevant experience - OR - M.S. in a Life Sciences discipline and 4+ years of relevant experience Experience within the biologic, pharmaceutical or medical device industry performing direct hands-on work in a Quality Aurance/Quality Control function with a strong familiarity of general GMP documentation Have the knowledge, and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks Familiarity with Good Manufacturing Practices (GMPs) and 21 CFR Familiarity with electronic systems, including Microsoft Access and Excel Experience supporting Federal government contracts is a plus ASQ CQA (American Society of Quality Certified Quality Auditor) 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
May 17, 2019
Full time
Paragon Bioservices is a contract development and manufacturing organization (CDMO) whose focus is the development and manufacturing of cutting-edge biopharmaceuticals. We provide 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. Paragon's scientists, engineers, quality experts, manufacturing operators and program managers are experts working with biologics from research and process development to GMP manufacturing for clinical trials and commercial launch. The Document Control Leader will be responsible for the overall leadership of the document control functions within the Quality Assurance group. This individual manages the life cycle of controlled documents ensuring regulatory requirements are met and leading continuous improvement initiatives. The Document Control function supports both the GMP and development operations. Key Responsibilities include but are not limited to: Provide strategic oversight of the document control systems ensuring phase appropriate processes to support Phase I/II operations with the ability to scale to support Phase III/commercial operations. Manages document control processes and systems for GMP activities in compliance with internal procedures and policies, as well as, regulatory requirements. Establishes and maintains the lifecycle of controlled documents, including but not limited to: records management system including version control, document distribution, archival, retrieval, retention and destruction. Define resource requirements, plans and prioritize resources, and manage personnel in daily duties and responsibilities based upon business and compliance requirements. Responsible for staffing, professional development of employees, and conducting performance reviews within group. Responsible for implementation, management, and enhancements of an electronic Document Management System (eDMS). Maintains document templates, project tracking logs, and databases through standard electronic formats. Continuous reviews of all systems and procedures (SOPs) for efficiency and regulatory compliance improvements. Leads and identifies continuous improvement initiatives. Contributes to the overall management of client specific documentation. Experience & Education: Bachelor's or Master's degree in a Life Science field 10 years of relevant experience within the life sciences industry, preferably biotechnology or pharmaceuticals, performing within a Quality Assurance role with some or all of that time responsible for Document Control activities Thorough knowledge of cGMP regulations, quality systems and regulatory requirements 6 years of direct management experience • Proficiency with electronic management systems (such as QDMS, LMS, EDMS, and E-Doc) Advanced skills with MS Office applications and Adobe Acrobat 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
May 17, 2019
Full time
Paragon Bioservices, Inc. (PBI) is a growing biopharmaceutical contract development and manufacturing organization with an internationally recognized tradition of quality and service. PBI provides process development and GMP manufacturing services for Phase I/II clinical trials to industry leaders as well as innovative start-ups utilizing novel technologies to produce state-of-the-art vaccines and therapies for people when they are most in need. As a PBI employee, you will actively contribute to the delivery of our services and products to our customers and their patients. The Metrologist functions independently and productively as a Facilities Metrologist and is actively engaged within the Facilities Engineering department to support the flow of calibrations in a dynamic team environment. Needs to be able to perform and properly document calibrations of a wide variety of instruments to include but is not limited to temperature, RPM, weight, PH, DO, flow, pressure, etc. All instruments/ equipment are for use in a highly regulated Biopharmaceutical environment. Key Responsibilities include but are not limited to: Will create, revise, and edit calibration SOP's and work order records Will work with calibration vendors to complete items due as needed Processing of equipment/facilities calibration, PM and responsive work order data through Paragon's equipment management software Will assist in the procurement and processing of purchase orders Will assist in asset management Works diligently on calibration tasks to ensure that all instruments are completed by their due date. Effectively communicates results of own work through discussions and documentation with some input from supervisor Train and follow GMP SOP's Will assist other departments including Engineering, Maintenance, Validation to accomplish company goals and tasks Other duties as assigned Experience & Education: High School Diploma or GED 2 years Metrology experience Experience working in a GMP environment Calibration/Metrology certification 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.
Paragon BioServices, Inc. Harmans, Severn, MD 21077, USA
May 17, 2019
Full time
Paragon Bioservices, Inc. (PBI) is a growing Biotech Contract Development and Manufacturing Organization (CDMO) with an internationally recognized tradition of quality and service. Paragon Bioservices provides process development and GMP manufacturing services for Phase I/II clinical trials to industry leaders as well as innovative start-ups utilizing novel technologies to produce state-of-the-art vaccines and therapies for people when they are most in need. As a PBI employee, you will actively contribute to the delivery of our services and products to our customers and their patients. The Sr. Buyer will be responsible for the execution of assigned procurement related activities specific to the GMP MRO materials and services needed to support all internal & client projects/programs. Additionally, this position will contribute to the development and implementation of strategic Supply Chain initiatives designed to facilitate continued company growth and scalability to Phase II and commercial manufacturing operations. This position will closely interface with Finance, Process Development, Manufacturing, Quality Assurance, Quality Control, and Project Management to ensure that purchased materials are compliant to internal and external regulations and available as required. Key responsibilities include but are not limited to: Perform all assigned buying functions for GMP manufacturing materials and services needed to support client requirements, manufacturing activities, and operations; with the objective to maximize material availability while maintaining a strategic inventory plan. Perform all assigned CAPEX equipment, non-CAPEX equipment, and MRO buying functions needed to support short and long-term company growth; with the objective to minimize cost while meeting all project timelines and deliverables. Negotiate price and delivery, along with terms and conditions for non-contract GMP materials and services. Manage orders to ensure materials meet the required delivery schedule(s) and comply with GMP requirements. Prepare RFPs and/or solicit quotations for materials, equipment, and services, as required. Analyze bids for specification compliance, pricing, and delivery commitments. Assist in monitoring and managing vendor and product performances. As assigned, support or lead strategic Supply Chain related initiatives and programs. Work with Planning to meet all manufacturing related inventory and Bills of Material requirements and adjustments. Work with Finance and Materials Control staff to reconcile any invoice and/or receiving related issues. Assist with the maintenance of Procurement master data within the ERP system (i.e. pricing, part numbers, supplier information, etc.). Provide exceptional customer service to internal customers. Employment & Education: High School Diploma/GED Sr. Buyer: 10 years procurement experience in a manufacturing environment with some or all in a GMP regulated environment. Will consider 8 years of experience with an Associates or Bachelors degree. Prior experience leading projects required Proficiency with ERP / MRP systems required Practical knowledge of lean supply practices a plus. Intermediate knowledge of Microsoft Office products, particularly MS Excel and Outlook. 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.
Paragon BioServices, Inc. Harmans, Severn, MD 21077, USA
May 17, 2019
Full time
Paragon Bioservices, Inc. (PBI) is a growing Biotech Contract Development and Manufacturing Organization (CDMO) with an internationally recognized tradition of quality and service. Paragon Bioservices provides process development and GMP manufacturing services for Phase I/II/III clinical trials to industry leaders as well as innovative start-ups utilizing novel technologies to produce state-of-the-art vaccines and therapies for people when they are most in need. As a PBI employee, you will actively contribute to the delivery of our services and products to our customers and their patients. The Materials Control Supervisor is responsible for providing supervision and leadership within the areas of inventory management, receiving, distribution, and warehouse operations to support site wide operations, including both cGMP and non-GMP operations. This position will closely interface with Finance, Process Development, Manufacturing, Quality Assurance, Quality Control, and Project Management to ensure that purchased materials are compliant to internal and external regulations and available as required. Key responsibilities include but are not limited to: Supervise receipt, processing, storage, and distribution of both cGMP and non-GMP materials per existing procedures and company practice in support of a single site multi-shift cGMP manufacturing operation Provide daily supervision and work prioritization for Materials Control Associates within the context of all intra-site operational activities Assess and implement cross training and coverage strategies to drive best practices in support of internal customers for multi-site cGMP manufacturing Assure all Materials Control staff are current on existing compliance and training requirements, as well as industry best practices Support a continuous improvement culture within the Materials Control group based on demonstration of best practices, strict adherence to cGMP compliance, service to internal customers, and staff professional growth Supervise shipping of client bulk drug substance, final drug product, and related samples Supervise collaboration of staff with other internal operational groups Act as a subject matter expert for all departmental practices Maintain intra-site inventory accuracy, from both a financial and compliance perspective, through robust ERP based cycle counting and reconciliation activities Able to maintain and segregate multi-client inventories across a wide range of storage conditions Collaborate with Supply Chain staff to identify and implement any value driven initiatives Other duties, as assigned in accordance with company requirements. Education & Experience: High School Diploma/GED and 5 years material control or warehouse experience with some or all of that experience in a GMP environment 1 year of supervisor or leadership experience Experience in developing and implementing warehouse processes, procedures, and systems. Knowledge of inventory management/ERP systems and Microsoft Office products. 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
May 17, 2019
Full time
Paragon Bioservices, Inc. (PBI) is a growing Biotech Contract Development and Manufacturing Organization (CDMO) with an internationally recognized tradition of quality and service. Paragon Bioservices provides process development and GMP manufacturing services for Phase I/II/III clinical trials to industry leaders as well as innovative start-ups utilizing novel technologies to produce state-of-the-art vaccines and therapies for people when they are most in need. As a PBI employee, you will actively contribute to the delivery of our services and products to our customers and their patients. The Material Planner I is responsible for managing all material related Planning activities needed to meet pre-clinical, early to late phase clinical, commercial, and process development manufacturing requirements. The principal objective of the Material Planner I is to coordinate and improve the material planning function within Paragon through the implementation of planning best practices and the full utilization of an ERP system. This position will closely interface with Finance, Process Development, Manufacturing, Quality Assurance, Quality Control, MS & T, and Project Management to ensure that all Manufacturing requirements are met and on-schedule. Key responsibilities include but are not limited to: Planning / Scheduling Execute material requirements planning for multiple manufacturing sites and multiple products. Ensure daily production requirements are achieved to meet the Master Production Schedule (MPS). Execute / monitor MRP calculations and messages. Drive maximum utilization of the ERP system (QAD) for all MRP functions and inventory control. Create and manage electronic Bills of Material, Production Orders, and Routings. Interface with the Manufacturing and Quality groups to resolve material availability and production tracking issues on a real time basis. Monitor the "MRP to consumption" flow of materials from receipt to issuance; including release testing and material disposition. Coordinate production, inventory management, and procurement activities by partnering with the Master Scheduler, Manufacturing, Materials Control, and Project Management. Work with Supply Chain to develop and implement inventory and planning strategies to support both MRP and non-MRP activities (i.e. reorder point planning, Kanban programs, safety stock demand planning, ABC categorization, etc.). Contribute to the lifecycle management process to optimize inventory, mitigate material expiry, and reduce scrap. ERP / Metrics Contribute to all Planning related ERP system Master Data. Act as a Supply Chain team member for all ERP system upgrades or new implementations. Develop and report appropriate Planning related metrics to inform the organization and drive continuous improvement. Other duties, as assigned in accordance with company requirements. Skills and Competencies: Practical knowledge of MRP, database management, inventory planning and forecasting, and product structures. Must be organized, possess time management skills, and be able to manage changing priorities. Ability to develop processes and act as a change catalyst. Strong analytical, problem solving, and communication skills. Qualifications: Previous material planning experience preferred, but other Supply Chain and/or Mfg Operations experience within the biotech/pharma/CMO industries will be considered. Bachelor's degree or higher. Proficiency with ERP / MRP systems. Experience in developing and implementing processes, procedures, and systems. Intermediate/Advanced knowledge of Microsoft Office products. 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