24 jobs found in College Station

Ref ID: 04242574 Classification: Financial Analyst Compensation: $55000.00 to $65000.00 yearly If you are seeking a Financial Analyst in which you could utilize your background in finance and excellent communication skills, Robert Half Finance may have the role you're looking for. Interested in joining an exciting company and growing team? Primary job functions consist of conducting financial modeling on various financial products as well as measuring, analyzing, and forecasting performance in conjunction with operating plans, advising management on the allocation of resources to best accomplish objectives, and preparing reports for management. This Financial Analyst role, which is located in the College Station, Texas, is a full-time employment opportunity. Do you consider forecasting, performance reporting, and expense management your strongest attributes? Then you may want to explore this business partner opportunity on a dynamic team. How you will make an impact - Enable successful Business Intelligence (BI) to deliver valuable foresight and decision support - Ensure plans are properly executed by working with cross-functional partners in Accounting and Operations - Survey performance to date and assess potential risks and opportunities - Keep track of monthly and quarterly performance by comparing actuals versus expectations and enabling business partners to handle their resources - Propel monthly reporting to business partners on financial results and actions necessary - Endorse weekly, quarterly and annual Area/Segment-level Bookings as well as P&L forecasting - An ideal candidate should be highly flexible, comfortable with large amounts of information, and adept at managing expectations - Work alongside senior executives on strategic deep dives to create financial models and insights on topics such as: Retention forecasts, event tracking and execution, Campaign Planning & Tracking, return on investment of strategic investments, and strategic resource allocation, and prioritization - Explain and understand internal and external drivers impacting performance and trending - Work with the Accounting team on monthly and quarterly financial close processes - Compose and oversee forecasting reports - Bachelor's Degree in finance, accounting or economics - Microsoft SQL experience - Prior knowledge in Spreadsheet and ERP system - Business Intelligence (BI) reporting tools experience a plus - Financial planning & analysis (go-to-market experience ideal) For immediate consideration, email Mark, Job Requirements: - Bachelor's Degree in finance, accounting or economics - Microsoft SQL experience - Prior knowledge in Spreadsheet and ERP system - Business Intelligence (BI) reporting tools experience a plus - Financial planning & analysis (go-to-market experience ideal) For immediate consideration, email Mark, Robert Half Finance & Accounting matches skilled finance and accounting professoinals in the areas of accounting, bookkeeping, finance, audit, taxation and more on a full-time basis. Our personalized approach, innovative matching technology and global network with local market expertise help you find the legal opportunities that match your skills and priorities - fast. By working with us, you have access to challenging opportunities, competitive compensation and benefits, and training to enhance your skill sets. From philanthropy to environmental stewardship to employee programs, Robert Half is proud to have an active role in the communities in which we live and work. Our company has appeared on FORTUNE's "Most Admired Companies" list every year since 1998. Download our mobile app to take your job search on the go! Contact your local office at or visit to apply for this job now or find out more about other job opportunities. All applicants applying for U.S. job openings must be authorized to work in the United States. All applicants applying for Canadian job openings must be authorized to work in Canada. © 2020 Robert Half Finance & Accounting. An Equal Opportunity Employer M/F/Disability/Veterans. By clicking 'Apply Now' you are agreeing to Robert Half Terms of Use .

Overview Summary: The Microbiology Analyst III will be responsible for the QC microbiological aspects of cGMP compliance and testing at the FujiFilm Biotechnologies Diosynth Texas (FDBT) Quality Control Laboratory. External US Essential Functions: Responsible for QC microbiological aspects of cGMP compliance and testing. Perform microbiological validations as needed for finished product and in process controls and buffers. Serve as SME for one or more of the functional streams: utility monitoring, environmental monitoring or material monitoring. Assist manufacturing personnel in the identification of microbiological root cause analysis and provide technical advice as needed. Participate in the investigation and review of alert and action limit investigations as needed and implements corrective action as appropriate. Participate in cleaning and process validation activities involving microbiology. Participate in the investigation of microbiological data deviations and PRs. Contribute to the preparation of technical proposals, amendments, reports and memoranda. Develop and/or contribute toward creating and revising microbiological Standard Operating Procedures (SOPs) and other current Good Manufacturing Practices (cGMP) documentation. Schedule monitoring procedures with follow-up responsibility to provide test results.Review of EM and product release data. Ensure lab is maintained (organized, clean, properly supplied) Perform other duties as assigned. Required Skills & Abilities: Sound aseptic technique and understanding of industry best practices, techniques, equipment, and materials. Ability to analyze raw data, assess assay and system suitability criteria. Ability to follow safety procedures outlined in the Chemical Hygiene Plan. Utilize SDS sheets to properly assess chemical hazards, spill response procedures, and PPE requirements if indicated. Good attention to detail and ability to utilize problem solving/trouble shooting skills. Good computer skills. Demonstrated written and oral communication skills. Demonstrated leadership skills. Strong organization and analytical skills. Working Conditions & Physical Requirements: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to: Experience prolonged standing, some bending, stooping, and stretching. Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required. Ability to sit for long periods to work on a computer. Potential for exposure to hazardous chemicals, gases, fumes, odors, mists, and dusts, and other hazardous materials. Ability to lift/pull/push 30 lbs on occasion and 15 lbs regularly. Ability to wear personal protective equipment including safety glasses, lab coat, and gloves. Attendance is mandatory. Minimum Qualifications: Master's degree preferably in Biochemistry, Chemistry, Biology or related field with two (2) years of relevant experience; OR Bachelor's degree preferably in Biochemistry, Chemistry, Biology or related field with four (4) years of relevant experience. AND 2 years of Experience in a GLP/GxP or comparable federally regulated environment. We are an equal opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law. If an accommodation to the application process is needed, please e-mail or call . Job Requirements:

Overview Summary: The Microbiology Analyst I will be responsible for assisting the QC microbiological aspects of cGMP compliance and testing at the FujiFilm Biotechnologies Diosynth Texas (FDBT) Quality Control Laboratory. External US Essential Functions: Assist with QC microbiological aspects of cGMP compliance and testing. Assist manufacturing personnel in the identification of microbiological root cause analysis and provide technical advice as needed. Participate in the investigation and review of alert and action limit investigations as needed.. Participate in cleaning and process validation activities involving microbiology. Assist in the investigation of microbiological data deviation results and PRs. Assist in creating and revising microbiological Standard Operating Procedures (SOPs) and other current Good Manufacturing Practices (cGMP) documentation. Assist in scheduling of monitoring procedures with follow-up responsibility to assist with providing test results. Assist in the review of EM and product release data. Ensure lab is maintained (organized, clean, & properly supplied). Perform other duties as assigned. Required Skills & Abilities: Sound aseptic technique and understanding of industry best practices, techniques, equipment, and materials. Ability to analyze raw data, assess assay and system suitability criteria. Ability to follow safety procedures outlined in the Chemical Hygiene Plan. Utilize SDS sheets to properly assess chemical hazards, spill response procedures, and PPE requirements if indicated. Good attention to detail and ability to utilize problem solving/trouble shooting skills. Good computer skills. Demonstrated written and oral communication skills. Demonstrated leadership skills. Strong organization and analytical skills. Working Conditions & Physical Requirements: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to: Experience prolonged standing, some bending, stooping, and stretching. Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required. Ability to sit for long periods to work on a computer. Potential for exposure to hazardous chemicals, gases, fumes, odors, mists, and dusts, and other hazardous materials. Ability to lift/pull/push 30 lbs on occasion and 15 lbs regularly. Ability to wear personal protective equipment including safety glasses, lab coat, and gloves. Attendance is mandatory. Minimum Qualifications: Bachelor's degree preferably in Biochemistry, Chemistry, Biology or related field; OR Associate of Science degree preferably in Biochemistry, Chemistry, Biology or related field with two (2) years of relevant experience. Preferred Qualifications: Pharmaceutical or biotechnology industry experience Pharmaceutical documentation practices experience Experience in a GLP/GxP or comparable federally regulated environment. We are an equal opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law. If an accommodation to the application process is needed, please e-mail or call . Job Requirements:

An exciting neurologist opportunity is now available in Texas. The facility has a growing patient demand, so they are accepting new candidates. The work days are mostly from 8 am to 5 pm. This is an outpatient only position seeing general bread and butter neurology cases. The incoming physician will see an average of 15 patients per day. Join another neurologist with great support via teleneurology. There is also teaching opportunities with their academic affiliation. H-1B visa sponsorship is available. This employed opportunity has a highly competitive compensation. You will be offered medical benefits, 30 days of PTO including CME, relocation assistance, a sign-on bonus, CME allowance, a 401k with matching, and malpractice with tail coverage. To get started, please submit your CV and references to Victoria Fournier at or call . All inquiries are confidential. Refer to job #. Not-for-profit facility with loan repayment Great support with teleneurology Completely outpatient general neurology with academic affiliation Very competitive compensation and sign-on bonus H-1B visa sponsorship Vibrant university town No state income tax Just over an hour to Austin and Houston Our services are free for you We help negotiate your salary and contract We coordinate interviews and help with licenses Specialized recruiters match your career preferences Experienced support teams take care of every detail

Overview Summary The Manufacturing Supervisor - Upstream will work directly with cell-culture and viral propagation techniques; cell-culture and bioreactor operations; bacterial and fermentation operations; pDNA, protein, and yeast-related operations; and aseptic techniques while following cGMP procedures. This individual will also supervise a team of employees directly or indirectly in the Upstream process. External US Essential Functions Operation of the following systems: Single-Use Cell Culture Vessels/Bioreactors up to 1000L Bacterial Fermentation Culture Vessels up to 1000L Alpha Wasserman Continuous Flow Centrifuges Disposable Magnetic Mixing Bags and Totes Cell Expansion and Propagation Banking/Cryopreservation of Cell Lines and Viruses Plate counting, microscopic examination. Prepare medium, monitor cultures, take samples, turn-around of bioreactor and fermenters, sterilization, and inoculation. Responsible for supervising daily manufacturing activities and staff, including hiring, performance evaluations, coaching, mentoring, disciplinary actions, termination recommendations, training, development, etc. Responsible for implementing project safety and quality assurance programs Develop, write, and review Standard Operating Procedures and Batch Production Records (BPRs). Responsible for ensuring proper documentation and execution of BPRs and activity records, according to cGMP regulations. Lead deviation resolution and closure with subject matter expert and quality teams. Responsible for tracking CAPAs to closure. Provide input and support to R&D functions during development and scale up activities as necessary. Represents organization in client meetings as the subject matter expert with regard to assigned manufacturing processes. Ensure an adequate supply of materials available; ensure all materials for project are procured prior to production. Maintain the confidentiality of proprietary company information. Responsible for continuous improvement in areas of responsibility. Maintain an effective working relationship with others. Perform all other duties as assigned. Required Skills & Abilities: Demonstrated leadership, coaching and mentoring skills. Demonstrated experience in training others to perform and maintain cGMP standards Excellent skills with Microsoft Office applications. Must have flexible work hours, and be willing to work outside of normal, scheduled hours; as necessary. Must be able to work alternative shift hours and weekends as required. Excellent self-discipline and attention to detail. Advanced math and computer skills. Must have exceptional planning and organizational skills, excellent oral and written communication skills, and be proactive in process interfacing with colleagues in various roles and functions throughout the manufacturing facilities. Demonstrated ability to work with teams and collaborate with others. Excellent problem-solving skills. Working Conditions & Physical Requirements: The physical demands described here are representative of those that must be met by an employee, in order to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. While performing the duties of this job, the employee is required on a regular basis to: Experience prolonged standing, some bending, pushing, pulling, reaching above the shoulder, stooping, and stretching. Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Ability to lift up to 25 pounds frequently and up to 50 pounds on occasion. Attendance is mandatory. Minimum Qualifications: Master's degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or related field with 4 years of experience in a manufacturing environment which includes 2 years of cGMP experience and at least 1 year of lead or supervisory experience. Undergraduate degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or related field with 6 years of experience in a manufacturing environment which includes 2 years of cGMP experience and at least 1 year of lead or supervisory experience. Associate's Degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or related field with 8 years of experience in a manufacturing environment which includes 2 years of cGMP experience and at least 1 year of lead or supervisory experience. Experience with cultivation at a minimum of pilot scale cell culture vessels. Experience with Mammalian Cell, Insect Cell, Yeast and Bacterial Cell Lines. Experience with MAb, pDNA, and Viral Propagation technologies. Preferred Qualifications: Biotechnology Certificate Green-Belt Certification We are an equal opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law. If an accommodation to the application process is needed, please e-mail or call . Job Requirements:

Overview The Manufacturing Supervisor will work directly with a range of purification technologies including viral filtration, Tangential Flow Filtration, Depth Filtration, Dead-end Filtration, chromatographic separations technologies (GE AKTA systems), Viral Inactivation and Final Filling Operations following cGMP requirements. This individual will also supervise a team of employees directly or indirectly in the Downstream process. External US Essential Functions: Operation and familiarity with the following systems: Medium to Large-scale filtration systems including Tangential Flow Filtration (TFF) and depth filtration. Medium to Large-scale Chromatographic systems (ÄKTA). Pre-Packed Columns from 10L to 100L. Single use mixing systems (Pall & GE). Single Use connectivity types such as GE DAC and Colder AseptiQuik SAP Inventory control and consumption Responsible for supervising daily manufacturing activities and staff, performance evaluations, coaching, mentoring, disciplinary actions, training, development, etc. Responsible for implementing project safety and quality assurance programs. Develop, write, and review Standard Operating Procedures and Batch Production Records (BPRs). Responsible for ensuring proper documentation and execution of BPRs and activity records, according to cGMP regulations. Lead deviation resolution and closure with subject matter expert and quality teams. Responsible for tracking CAPAs to closure. Provide input and support to Process Development and Technical Operation functions during development and scale-up activities as necessary. Represents organization in client meetings as the subject matter expert with regard to assigned manufacturing processes. Ensure an adequate supply of materials available; ensure all materials for project(s) are procured prior to production. Promote and facilitate cross functional training within the organization Maintain the confidentiality of proprietary company information. Responsible for continuous improvement in areas of responsibility. Maintain an effective working relationship with others. Perform all other duties as assigned. Required Skills & Abilities: Demonstrated leadership, coaching and mentoring skills. Demonstrated experience in training others to perform and maintain cGMP standards Excellent skills with Microsoft Office applications (Word, Excel, PowerPoint). Must have flexible work hours, and be willing to work outside of normal, scheduled hours, as necessary. Must be able to work alternative shift hours and weekends as required. Excellent self-discipline and attention to detail. Advanced math and computer skills. Must have exceptional planning and organizational skills, excellent oral and written communication skills, and be proactive in process interfacing with colleagues in various roles and functions throughout the manufacturing facilities. Demonstrated ability to work with teams and collaborate with others. Excellent problem-solving skills. Working Conditions & Physical Requirements: The physical demands described here are representative of those that must be met by an employee, in order to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. While performing the duties of this job, the employee is required on a regular basis to: Experience prolonged standing, some bending, pushing, pulling, reaching above the shoulder, stooping, and stretching. Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Ability to lift up to 25 pounds frequently and up to 50 pounds on occasion. Attendance is mandatory. Minimum Qualifications: Master's degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or other related field and 3 years of relevant experience; OR Bachelor's degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or other related field and 5 years of relevant experience; OR Associates degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or other related field and 7 years of relevant experience; OR High School/GED with 9 years of relevant experience. Above experience must include three (3) years of cGMP. Preferred Qualifications: Biotechnology Certificate Six Sigma Certification Job Requirements:

Overview Summary: The Bio-Manufacturing Supervisor - Downstream will work directly with a range of purification technologies including continuous flow centrifugation, sucrose gradient separation, various filtration technologies (TFF & depth), chromatographic separations technologies (GE AKTA systems), and viral inactivation following aseptic technique in a cGMP environment. This individual will also supervise a team of employees directly or indirectly in the Downstream process. External US Essential Functions: Operation and familiarity with the following systems: Large-scale filtration systems including Tangential Flow Filtration (TFF) and depth filtration. Large-scale centrifugation systems including Sucrose Density Centrifugation, Continuous Flow Centrifugation, and Clarification. Large-scale Chromatographic systems (ÄKTA). Experience with single use systems. Responsible for supervising daily manufacturing activities and staff, including hiring, performance evaluations, coaching, mentoring, disciplinary actions, termination recommendations, training, development, etc. Responsible for implementing project safety and quality assurance programs. Develop, write, and review Standard Operating Procedures and Batch Production Records (BPRs). Responsible for ensuring proper documentation and execution of BPRs and activity records, according to cGMP regulations. Lead deviation resolution and closure with subject matter expert and quality teams. Responsible for tracking CAPAs to closure. Provide input and support to R&D functions during development and scale-up activities as necessary. Represents organization in client meetings as the subject matter expert with regard to assigned manufacturing processes. Ensure an adequate supply of materials available; ensure all materials for project(s) are procured prior to production. Maintain the confidentiality of proprietary company information. Responsible for continuous improvement in areas of responsibility. Maintain an effective working relationship with others. Perform all other duties as assigned. Required Skills & Abilities: Demonstrated leadership, coaching and mentoring skills. Demonstrated experience in training others to perform and maintain cGMP standards Excellent skills with Microsoft Office applications (Word, Excel, PowerPoint). Must have flexible work hours, and be willing to work outside of normal, scheduled hours, as necessary. Must be able to work alternative shift hours and weekends as required. Excellent self-discipline and attention to detail. Advanced math and computer skills. Must have exceptional planning and organizational skills, excellent oral and written communication skills, and be proactive in process interfacing with colleagues in various roles and functions throughout the manufacturing facilities. Demonstrated ability to work with teams and collaborate with others. Excellent problem-solving skills. Working Conditions & Physical Requirements: The physical demands described here are representative of those that must be met by an employee, in order to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. While performing the duties of this job, the employee is required on a regular basis to: Experience prolonged standing, some bending, pushing, pulling, reaching above the shoulder, stooping, and stretching. Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Ability to lift up to 25 pounds frequently and up to 50 pounds on occasion. Attendance is mandatory. Minimum Qualifications: Master's degree preferably in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or related field with 4 years of experience in a manufacturing environment which includes 2 years of GXP experience and lead or supervisory experience; OR Bachelor's degree preferably in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or related field with 6 years of experience in a manufacturing environment which includes 2 years of GXP experience and lead or supervisory experience; OR High School or Associates Degree preferably in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or related field with 10 years of experience in a manufacturing environment which includes 5 years of GXP experience and lead or supervisory experience. Preferred Qualifications: Biotechnology Certificate Six Sigma Certification We are an equal opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law. If an accommodation to the application process is needed, please e-mail or call . Job Requirements:

Overview Summary : The Manufacturing Readiness Coordinator assists the Manufacturing team to ensure right-first-time execution on the GMP manufacturing floor and on time starts by coordinating and delivering readiness milestones. External US Essential Functions: Responsible for participating in the following activities within the Manufacturing Support Services function: Materials/Consumables Draft and finalize process consumables list for new client programs Work with Supply Chain, Process Development, Manufacturing Operations, Quality Control, and Quality Assurance to identify materials and consumables appropriate for GMP manufacture. Prepare material specifications to enable purchasing and release of materials/consumables for use in GMP manufacture. Coordinate purchase order creation for client owned/client delivered materials Deliver inputs and outputs necessary for SAP recipe creation Works with Manufacturing and Supply Chain to follow-up on material ordering and receipt status for GMP manufacturing. Documents Create standard work for manufacturing readiness, execution, and disposition activities for new customer programs Author batch records Review Process Specification Create tier 2 placards for each new client program. Review campaign summary report Support Failure Modes and Effects Analysis (FMEA) risk assessments. Support Potential Problem Analysis (PPA) events Equipment and Readiness Coordination Coordinate room/equipment changeover Coordinate room release Coordinate schedule for water runs Review Unicorn methods Provide PIP support Originates and tracks manufacturing work orders as necessary. Performs all other duties as assigned. Continuous Learning and Improvement Participates in team projects relating to Operational Excellence such as Problem Analysis and Prevention Required Skills & Abilities: Good oral and written communication skills, interpersonal and organizational skills. Practical understanding of equipment used in bioprocessing (downstream and/or upstream) Proficient with Microsoft Office applications. Good self-discipline and attention to detail. Must have flexible work hours - must be willing to work outside of normally-scheduled hours as necessary; including opportunities for alternative shift-hours and weekends as required. Experience working in cleanroom environments. Must have good planning skills and must be willing to interface with and support team members in many different roles and functions throughout the manufacturing facilities. Working Conditions & Physical Requirements: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to: Experience prolonged standing, some bending, stooping, pushing, pulling, reaching above shoulders and stretching. Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Lift up to 25 pounds frequently and up to 50 pounds, on occasion. Attendance is mandatory. Qualifications: High School Diploma or GED and two (2) years' experience preferably in biopharmaceutical manufacturing (GLP or GMP) or supply chain operations; OR Associate's Degree and one (1) year of experience. Preferred Qualifications: Experience with both Upstream and Downstream cell culture processes Experience with material control and testing requirements We are an equal opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law. If an accommodation to the application process is needed, please e-mail or call . Job Requirements:

Overview Summary: The Manufacturing Supervisor will work directly with a range of purification technologies including viral filtration, Tangential Flow Filtration, Depth Filtration, Dead-end Filtration, chromatographic separations technologies (GE AKTA systems), Viral Inactivation and Final Filling Operations following cGMP requirements. This individual will also supervise a team of employees directly or indirectly in the Downstream process. External US Essential Functions: Operation and familiarity with the following systems: Medium to Large-scale filtration systems including Tangential Flow Filtration (TFF) and depth filtration. Medium to Large-scale Chromatographic systems (ÄKTA). Pre-Packed Columns from 10L to 100L. Single use mixing systems (Pall & GE). Single Use connectivity types such as GE DAC and Colder AseptiQuik SAP Inventory control and consumption Responsible for supervising daily manufacturing activities and staff, performance evaluations, coaching, mentoring, disciplinary actions, training, development, etc. Responsible for implementing project safety and quality assurance programs. Develop, write, and review Standard Operating Procedures and Batch Production Records (BPRs). Responsible for ensuring proper documentation and execution of BPRs and activity records, according to cGMP regulations. Lead deviation resolution and closure with subject matter expert and quality teams. Responsible for tracking CAPAs to closure. Provide input and support to Process Development and Technical Operation functions during development and scale-up activities as necessary. Represents organization in client meetings as the subject matter expert with regard to assigned manufacturing processes. Ensure an adequate supply of materials available; ensure all materials for project(s) are procured prior to production. Promote and facilitate cross functional training within the organization Maintain the confidentiality of proprietary company information. Responsible for continuous improvement in areas of responsibility. Maintain an effective working relationship with others. Perform all other duties as assigned. Required Skills & Abilities: Demonstrated leadership, coaching and mentoring skills. Demonstrated experience in training others to perform and maintain cGMP standards Excellent skills with Microsoft Office applications (Word, Excel, PowerPoint). Must have flexible work hours, and be willing to work outside of normal, scheduled hours, as necessary. Must be able to work alternative shift hours and weekends as required. Excellent self-discipline and attention to detail. Advanced math and computer skills. Must have exceptional planning and organizational skills, excellent oral and written communication skills, and be proactive in process interfacing with colleagues in various roles and functions throughout the manufacturing facilities. Demonstrated ability to work with teams and collaborate with others. Excellent problem-solving skills. Working Conditions & Physical Requirements: The physical demands described here are representative of those that must be met by an employee, in order to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. While performing the duties of this job, the employee is required on a regular basis to: Experience prolonged standing, some bending, pushing, pulling, reaching above the shoulder, stooping, and stretching. Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Ability to lift up to 25 pounds frequently and up to 50 pounds on occasion. Attendance is mandatory. Minimum Qualifications: Master's degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or other related field and 3 years of relevant experience; OR Bachelor's degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or other related field and 5 years of relevant experience; OR Associates degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or other related field and 7 years of relevant experience; OR High School/GED with 9 years of relevant experience. Above experience must include three (3) years of cGMP. Preferred Qualifications: Biotechnology Certificate Six Sigma Certification Job Requirements:

Overview Summary : The Senior Manufacturing Lead - Upstream will lead a team and work directly with a range of technologies following aseptic techniques and procedures in a cGMP environment. External US Essential Functions: Responsible for leading a team in preparing medium, monitoring cultures, taking samples, turn-around of bioreactors and inoculations. Responsible for coordinating daily manufacturing floor activities. Responsible for overseeing and/or performing cell counting and microscopic examination. Responsible for writing, reviewing, and/or updating Standard Operating Procedures (SOPs) and Batch Production Records (BPRs). Coordinate and implement project safety and quality assurance programs in collaboration with senior staff and EH&S. Maintain confidentiality of proprietary company information. Document and maintain activity records according to cGMP regulations and ensure team members are properly trained on all proper processes. Maintain an effective working relationship with others. Ensure proper documentation and execution of Batch Production Records for assigned projects. Participate in and/or lead incident investigations. Perform all other duties as assigned. NCTM/Building 200 Essential Functions: Operation of the following systems: Single-Use Cell Culture Vessels/Bioreactors up to 1000L Bacterial Fermentation Culture Vessels up to 1000L Alpha Wasserman Continuous Flow Centrifuges Disposable Magnetic Mixing Bags and Totes Cell Expansion and Propagation Banking/Cryopreservation of Cell Lines and Viruses Lead team in cell-culture and viral propagation techniques; cell-culture and bioreactor operations; bacterial and fermentation operations; pDNA, protein, and yeast-related operations; and aseptic techniques. Provide input and support to Process Development functions during development and scale up activities. Building 100 Essential Functions: Lead team in working with mammalian cell culture processes including: shake flask inoculations, single use bioreactor operations, cell recovery, etc. Lead team to produce requirements in operating and monitoring equipment through observing varying conditions, adjusting equipment controls, calculating concentrations, dilutions, and yields. Ability to operate and train team in the use of general production equipment such as Incubators, Analytical Scales, pH/conductivity meters, etc. Required Skills & Abilities: Excellent oral and written communication skills as well as excellent interpersonal and organizational skills. Demonstrated leadership skills. Ability to train others to perform and maintain cGMP standards. Strong proficiency with Microsoft Office applications. Experience working in cleanroom environments. Self-discipline and good attention to detail. Must have flexible work hours - must be willing to work outside of normally-scheduled hours as necessary; including opportunities for alternative shift-hour and weekends as required. Excellent math and computer skills. Must have exceptional planning skills and be willing to interface with colleagues in many different roles and functions throughout the manufacturing facilities and lead projects. Working Conditions & Physical Requirements: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to: Experience prolonged standing, some bending, stooping, and stretching. Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Ability to lift up to 25 pounds; frequently, and up to 50 pounds; on occasion. Attendance is mandatory. Minimum Qualifications: Master's Degree preferably in Biology, Microbiology, Chemistry, Biochemistry, Engineering or related field with 3 years relevant experience of which 2 years must be in a GMP environment; OR Bachelor's Degree preferably in Biology, Microbiology, Chemistry, Biochemistry, Engineering or related field with 5 years relevant experience of which 2 years must be in a GMP environment; OR Associates Degree preferably in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or related field with 7 years relevant experience of which 2 years must be in a GMP environment. High School Diploma or Associates Degree preferably in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or related field with 9 years relevant experience of which 2 years must be in a GMP environment. Experience with cultivation of cell culture vessels at the pilot scale level or greater. Experience with Mammalian Cell or Insect Cell, Yeast or Bacterial Cell Lines. Experience with MAb, pDNA, and/or Viral Propagation technologies. Preferred Qualifications: Six Sigma Certification Job Requirements:

Overview Summary : The Upstream Manufacturing Technician II will work directly with cell culture and viral propagation techniques, buffer and equipment preparations, cell culture and bioreactor operation, bacterial and fermentation operations, and aseptic technique following GMP procedures. External US Essential Functions: Prepare medium and equipment, monitor cultures, take samples, turn-around of fermenters and bioreactors, sterilization and inoculation. Plate counting, microscopic examination. Operate general production equipment such as Autoclaves, Glass washers, Incubators, Analytical Scales, pH/conductivity meters, etc. Participate in writing standard operating procedures and batch production records. Experience with cultivation and/or pilot scale cell culture vessels. Participate with senior staff in implementing project safety and quality assurance programs. Maintain the confidentiality of proprietary company information. Document and maintain activity records according to cGMP regulations. Perform daily cleaning and sanitization of the laboratory. Maintain an effective working relationship with others. Perform all other duties as assigned. Required Skills & Abilities: Excellent oral and written communication skills, interpersonal and organizational skills. Excellent proficiency with Microsoft Office applications. Good self-discipline and attention to detail. Must have flexible work hours - must be willing to work outside of normal scheduled hours as necessary. Must be able to work alternative shift hours and weekends as required. Good math and computer skills. Experience working in a clean room environment. Must possess excellent planning and time-management skills, and be willing and able to interface with colleagues in various roles and functions, throughout the manufacturing facilities. Working Conditions & Physical Requirements: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to: Experience prolonged standing, some bending, stooping, pushing, pulling, reaching above shoulders and stretching. Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Lift up to 25 pounds frequently and up to 50 pounds, on occasion. Attendance is mandatory. Minimum Qualifications: Bachelor's degree preferably in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or other related field, and 2 years of relevant experience: OR Associate's degree preferably in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or other related field, and 3 years of relevant experience; OR High School/GED with 5 years relevant experience. Preferred Qualifications: Experience in GMP environment Biotechnology Certificate Job Requirements:

Overview Summary: The Quality Control Cell Biology Lead, with limited supervision, will be responsible for overseeing day to day operations of the QC Cell Biology Group. This position will involve handing out daily assignments, ensuring assignments are completed within the given time period, and reviewing data. The Quality Control Cell Biology Lead will also participate in Project Team Meetings. The successful candidate will assist in Method Qualifications, Technology Transfer of established methods, and performing in-process, release and stability testing as needed. External US Essential Functions: Oversee day to day activities of the Cell Biology Mentor junior analysts in conducting analytical testing, equipment troubleshooting, and Good Documentation Practices (GDP) Responsible for reviewing data generated by the QC Cell Biology Oversee equipment PM and calibrations to ensure the laboratory maintains GMP compliancy. Responsible for Equipment logbook review as needed. Perform QC analytical testing for GMP in-process, release and stability testing as needed: Executes technical transfer, qualification and validation protocols as needed. Technical Writing to include: Writes and revises Standard Operating Procedures (SOPs) and other Good Manufacturing Practices (GMP) documentation as appropriate. Writes, reviews, approves Qualification protocols Writes, reviews, approves Transfer Protocols Creating manuals for processes/activities Review and edit Sample Plans Author Product Specifications Assisting and initiating closure of deviations, CAPAs and Change Controls Reviewing Methods for accuracy: Develop and support a system for managing test samples, reagents and reference standards. Reports excursion/out of specifications. Leads OOS investigations as needed. Perform other duties as assigned. Required Skills & Abilities: Ability to analyze raw data, assess assay and system suitability criteria, understand process from beginning to end. Excellent communication skills. Ability to work independently or in a team. Perform as a SME in the designated methods transferred into FDBT. Ability to follow safety procedures outlined in the Chemical Hygiene Plan. Utilize SDS sheets to properly assess chemical hazards, spill response procedures, and PPE requirements if indicated. Excellent attention to detail. Computer proficiency required. Excellent written and oral communication skills. Excellent organization and analytical skills. Working Conditions & Physical Requirements: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to: Experience prolonged standing, some bending, stooping, and stretching. Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required. Ability to sit for long periods to work on a computer. Potential for exposure to hazardous chemicals, gases, fumes, odors, mists, and dusts, and other hazardous materials. Ability to wear personal protective equipment including safety glasses, lab coat, and gloves. Ability to lift up to 30 pounds on occasion. Attendance is mandatory. Minimum Qualifications: Master's degree preferably in Biology with 4 years hands on laboratory experience; OR Bachelor's degree preferably in Biology with 8 years hands on laboratory experience. Minimum of 1 year serving a team leader/ cell biology in a GMP Environment Preferred Qualifications: Familiar with both monoclonal antibody and gene therapy testing methodologies. Experienced in assay troubleshooting and problem solving. Salary: Starting salary will be commensurate with education and experience. Job Requirements:

Overview Summary : The Senior Scientist Upstream will provide technology leadership for the Upstream Process Development for a variety of technical platforms, provide technical support for associated regulatory filings, and improve processes or propose modifications to equipment to deliver improvements. The Senior Scientist will act as technical lead for the development and optimization of novel cell culture and bioreactor processes for multiple viral projects. Responsibilities include cell line selection, process development, process scale-up, and tech transfer. Requires hands-on execution of process optimization, cell culture media, along with process characterization of cell culture production processes that can be transferred to the Manufacturing group as well as external collaborators. External US Essential Functions: Develop scalable, robust, high yielding, and economically viable cell culture processes using miniature, bench-scale, and larger disposable bioreactors in the laboratory setting for the production of viral vectors. Provides in plant support for cGMP manufacturing of preclinical and clinical materials. Set-up, operate, and troubleshoot single use stirred tank bioreactors up to 200L scale. Carry out upstream process research and development on a variety of microbial and cell culture derived biopharmaceuticals including MAbs, Immunoglobulins, vaccines (e.g. pDNA & viral), etc. Assist in achieving high yielding cGMP biopharmaceutical production through clone selection, media and feed development, seed train optimization, bioreactor process scale-up, clone stability testing and effective transfer to manufacturing. Lead projects to develop and optimize analytical methods for product quality assessment. Maintain and monitor process development equipment. Propose modifications to processes or equipment to deliver improvements. Support analytical evaluation, interpret data and work with other team members to integrate results into overall process development plans. Generate, manage and evaluate critical data and records of all upstream process development operations in support of regulatory requirements. Collaborate and coordinate with colleagues as necessary to facilitate in technology transfer of processes, e.g., Downstream, QA, QC, etc. Develop and provide technical reports, data analysis, SOP's, and investigate and complete deviations as need. Evaluate and implement new technologies for upstream process development. All other duties as required. Required Skills & Abilities: Hands on experience with mammalian and/or insect cell culture, aseptic techniques. Proven experience in the scale up and technology transfer from pilot plant to commercial scale Cell culture protocol experience using HYPERStack vessels. Proven experience using Icellis bioreactors and Triton CF 10 cell culture vessels. Proven experience in adherent and suspension cell culture lines. Excellent organizational, interpersonal, analytical skills, and problem solving skills. Experience/familiarity with cell culture and cell based assays is required. Working Conditions & Physical Requirements: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to: Experience prolonged standing, along with some bending, stooping, and stretching. Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Potential for exposure to hazardous chemicals, gases, fumes, odors, mists, and dusts, and other hazardous materials. Ability to lift 50 pounds on occasion and 25 pounds regularly. Ability to wear PPE. Attendance is mandatory. Qualifications: PhD preferably in Biochemistry, Chemistry, Biology, Engineering or related field with 2 years relevant industry experience; OR Master's Degree preferably in Biochemistry, Chemistry, Biology, Engineering, or related field with 6 years relevant industry experience. Preferred Qualifications: Hands-on upstream process transfer experience. Experience working in a cGMP facility. Technical Project Management experience. We are an equal opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law. If an accommodation to the application process is needed, please e-mail or call . Job Requirements:

Overview Summary : The Downstream Manufacturing Technician III will work directly with a range of purification technologies including continuous flow centrifugation, sucrose gradient separation, filtration technologies (TFF and depth), chromatographic separations (GE AKTA systems), and viral inactivation following aseptic technique in a cGMP environment. External US Essential Functions: Operation of chromatographic systems (GE AKTA). Operation of large scale centrifugation equipment. Operation of filtration systems including Tangential Flow Filtration, Depth Filtration and Clarification. Write and review standard operating procedures and batch production records. Assist senior staff in implementing project safety and quality assurance programs in accordance with SOPs. Maintain the confidentiality of proprietary company information. Document and maintain activity records according to cGMP regulations and ensure junior team members are trained. Operate general production equipment such as Autoclaves, Glass washers, Incubators, Analytical Scales, pH/conductivity meters, etc. Perform daily cleaning and sanitization of the laboratory and manufacturing areas. Maintain an effective working relationship with others. Perform all other duties as assigned. Required Skills & Abilities: Excellent oral and written communication skills, interpersonal and organizational skills. Proficient with Microsoft Office applications. Excellent leadership skills. Ability to train others to perform to cGMP standards. Good self-discipline and attention to detail. Must have flexible work hours, and be willing to work outside of normal, scheduled hours; as necessary. Must be able to work alternative shift hours and weekends as required. Excellent math and computer skills. Experience working in a cleanroom environment with full clean room gowning and good aseptic technique. Must have good planning and time management skills and be willing and able to interface with colleagues in many different roles and functions throughout the manufacturing facilities. Working Conditions & Physical Requirements: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to: Experience prolonged standing, some bending, stooping, pushing, pulling, reaching above shoulders and stretching. Hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Lift up to 25 pounds frequently and up to 50 pounds occasionally. Attendance is mandatory. Minimum Qualifications: Master's degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering or other related field and 1 year of relevant experience; OR Bachelor's degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering or other related field and 3 years of relevant experience; OR Associate's degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering or other related field and 5 years of relevant experience; OR High School/GED with 7 years of relevant experience. Above experience must include one (1) year GXP experience. Preferred Qualifications: Biotechnology certificate preferred. Cross training with Downstream processes or other identified functional areas. Job Requirements:

Overview Summary : The Downstream Manufacturing Technician II will work directly with a range of purification technologies and equipment including centrifugation, sucrose gradient separation, filtration, chromatographic separation (i.e. column chromatography) and viral inactivation following aseptic technique and GMP procedures. External US Essential Functions: Technician II will be responsible for: Experience with GE AKTA systems. Continuous Flow Centrifugation. Filtration technologies including Tangential Flow Filtration, Depth Filtration and Clarification. Buffer Preparation. Operate general production equipment such as Autoclaves, Glass washers, Incubators, Analytical Scales, pH/conductivity meters, etc. Participate in writing standard operating procedures and batch production records. Participate with senior staff in implementing project safety and quality assurance programs. Document and maintain activity records according to cGMP regulations. Perform daily cleaning and sanitization of the laboratory and manufacturing areas. Assist in training less experienced Manufacturing Technicians. Maintain an effective working relationship with others. Perform all other duties as assigned. Required Skills & Abilities: Excellent oral and written communication skills, interpersonal and organizational skills. Excellent proficiency with Microsoft Office applications. Good self-discipline and attention to detail. Must have flexible work hours, and be willing to work outside of normal, scheduled hours; as necessary. Must be able to work alternative shift hours and weekends as required. Good math and computer skills. Experience working in a cleanroom environment with full clean room gowning and good aseptic technique. Must have good planning and time management skills and be willing and able to interface with colleagues in many different roles and functions throughout the manufacturing facilities. Working Conditions & Physical Requirements: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to: Experience prolonged standing, some bending, stooping, pushing, pulling, reaching above shoulders and stretching. Hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Lift up to 25 pounds frequently and up to 50 pounds occasionally. Attendance is mandatory. Minimum Qualifications: Bachelor's degree preferably in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or other related field, and 2 years of relevant experience: OR Associate's degree preferably in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or other related field, and 3 years of relevant experience; OR High School/GED with 5 years relevant experience. Preferred Qualifications: Experience in GMP environment Biotechnology Certificate Job Requirements:

Overview Summary : This position is responsible for establishing a production and supporting cross-functional activities plan to enable to delivery of products from FDBT's three manufacturing facilities per the site Sales & Operations Plan. This position is responsible for scheduling product change over, room release, equipment movement, equipment calibration/qualification activities, GMP document issuance, materials staging, buffer preparation, unit operations schedule, and batch record review schedule. External US Essential Functions: Develops the macro and micro schedules to support Buffer Prep, Central Services, Upstream, and Downstream Manufacturing for each product. Act as a primary contact with Manufacturing to maximize resource utilization and cross-departmental collaboration. Works with Supply Chain to understand any material concerns or shortages and communicates schedule changes to Supply Chain for material assessments. Works with readiness coordinators and production managers within Manufacturing to ensure materials and records are available to meet production schedules. Identify and communicate resource (people, equipment, facilities) gaps for the new business pipeline to site leadership and program managers. Collaborate with manufacturing and program management to ensure buy-in for execution of the manufacturing plan. Maintain manufacturing metrics for on time supply and success for weekly and monthly reports. Required Skills & Abilities: Ability to coordinate, facilitate and organize resources. Ability to develop strategic relationships; strong verbal and written communication skills. Must possess good to excellent writing and PC skills with a knowledge base in Microsoft Word, Excel, Power Point, and Project, and Schedule Pro. Mathematical and reasoning ability. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Strong organizational skills. Detail oriented and accurate. Proven success in leading complex projects and bringing them to conclusion. Ability to persuasively champion strategic ideas, as supported by sound rationale and analysis, and drive change within the organization. Strong knowledge of concepts, practices, and procedures related to the biotechnology industry. Strong analytical, interpersonal, presentation and problem solving skills. Ability to analyze, break-down, and interpret a wide variety of information and form a strategic opinion while addressing the operational implications. Self-discipline and good attention to detail. Excellent computer skills. Must have planning skills and be willing to interface with colleagues in many different roles and functions throughout the manufacturing facilities and to lead projects. Working Conditions & Physical Requirements: The physical demands described here are representative of those that must be met by an employee, in order to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. While performing the duties of this job, the employee is required on a regular basis to: Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Ability to lift up to 25 pounds; frequently, and up to 50 pounds; on occasion. Attendance is mandatory. Qualifications: Bachelor's degree in Science, Engineering or other related field and 3 years of relevant experience; OR Associate's degree in Science, Engineering or other related field and 5 years of relevant experience; OR High School diploma/GED with 7 years of Biopharmaceutical experience and or Planning experience. Preferred Qualifications: Experience in biotechnology or pharmaceutical industry. GMP experience. Job Requirements:

Overview Summary : The Upstream Manufacturing Technician I will work directly with cell-culture and viral propagation techniques, buffer and equipment preparations, cell-culture and bioreactor operation, bacterial and fermentation operations, and aseptic technique following GMP procedures. External US Essential Functions: Assist in the preparation of medium and equipment, help monitor cultures, take samples, turn-around of bioreactors and fermenters, sterilization and inoculation. Plate counting, microscopic examination. Operate general production equipment such as Autoclaves, Glass washers, Incubators, Scales, pH/conductivity meters, etc. Assist in writing standard operating procedures and batch production records in accordance with SOPs. Experience with cultivation and/or pilot-scale cell-culture vessels. Assist senior staff in implementing project safety and quality assurance programs. Maintain the confidentiality of proprietary company information. Document and maintain activity records according to cGMP regulations. Perform daily cleaning and sanitization of the laboratory. Maintain an effective working relationship with others. Perform all other duties as assigned. Required Skills & Abilities: Good oral and written communication skills, interpersonal and organizational skills. Strong proficiency with Microsoft Office applications. Good self-discipline and attention to detail. Must have flexible work hours, and be willing to work outside of normal, scheduled hours; as necessary. Must be able to work alternative shift hours, and weekends as required. Good math and computer skills. Must possess good planning and time-management skills and be willing and able to interface with colleagues in various roles and functions, throughout the manufacturing facilities. Working Conditions & Physical Requirements: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to: Experience prolonged standing, some bending, stooping, pushing, pulling, reaching above shoulders, and stretching. Use of hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Lift up to 25 pounds frequently and up to 50 pounds, on occasion. Attendance is mandatory. Minimum Qualifications: Associate's degree preferably in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or other related field; OR High School Diploma/GED and 1 year of work experience. Preferred Qualifications: Experience in a GMP environment Biotechnology Certificate Job Requirements:

Overview Summary : The Upstream Manufacturing Technician III will work directly with a range of technologies following aseptic techniques and procedures in a cGMP environment. External US Essential Functions: Responsible for medium, monitor cultures, take samples, turn-around of bioreactors and inoculation. Cell counting and microscopic examination. Prepare and formulate media and buffers in accordance to procedures. Write and review standard operating procedures and batch production records. Initiates deviations as needed, reporting and solving problems and issues. Assist senior staff in implementing project safety and quality assurance programs in accordance with SOPs. Maintain the confidentiality of proprietary company information. Operate general production equipment such as Incubators, Analytical Scales, pH/conductivity meters, etc. Document and maintain activity records according to cGMP regulations and ensure junior team members are trained. Assist in the training and provide technical coaching to junior staff members. Perform daily cleaning and sanitization of the manufacturing areas as needed. Maintain an effective working relationship with others. Perform all other duties as assigned. NCTM/Building 200 Essential Functions: Work with a range of technologies including cell-culture and viral propagation techniques; bacterial and fermentation operations; pDNA; Protein and Yeast related operations. Responsible for fermentation and non-mAb applications. Experience with cultivation and/or pilot scale cell culture vessels. Proficiency with BioCommand programming. Building 100 Essential Functions: Responsible for mammalian cell culture processes including: shake flask inoculations, single use bioreactor operation, cell recovery, etc. Producing requirements by operating and monitoring equipment, observing varying conditions, adjusting equipment controls, calculating concentrations, dilutions and yields. Operate general production equipment such as Incubators, Analytical Scales, pH/conductivity meters, etc. Required Skills & Abilities: Strong oral and written communication skills, interpersonal and organizational skills. Proficient with Microsoft Office applications. Strong leadership skills. Ability to train others to perform to cGMP standards. Good self-discipline and attention to detail. Must have flexible work hours, and be willing to work outside of normal, scheduled hours; as necessary. Must be able to work alternative shift hours and weekends as required. Strong math and computer skills. Experience working in a cleanroom environment with full clean room gowning and good aseptic technique. Must have good planning and time management skills and be willing and able to interface with colleagues in many different roles and functions throughout the manufacturing facilities. Working Conditions & Physical Requirements: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to: Experience prolonged standing, some bending, stooping, pushing, pulling, reaching above shoulders and stretching. Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Lift up to 25 pounds frequently and up to 50 pounds, on occasion. Attendance is mandatory. Minimum Qualifications: Master's degree preferably in Biology, Microbiology, Chemistry, Biochemistry, Engineering or other related field and 1 year of relevant experience; OR Bachelor's degree preferably in Biology, Microbiology, Chemistry, Biochemistry, Engineering or other related field and 3 years of relevant experience; OR Associate's degree preferably in Biology, Microbiology, Chemistry, Biochemistry, Engineering or other related field and 5 years of relevant experience; OR High School/GED with 7 years of relevant experience. Above experience must include one (1) year GMP experience. Preferred Qualifications: Biotechnology certificate preferred. Cross training with downstream processes or other identified functional areas. Job Requirements:

Overview Summary : The Downstream Manufacturing Technician I will work directly with viral purification (either whole particle or split particle), continuous flow centrifuge operation, and sucrose gradient separation, techniques for filtration and chromatographic separation (i.e. column chromatography and HPLC) and viral inactivation. External US Essential Functions: Technician I will be responsible for: Systems setup and turnaround of GE AKTA systems. Continuous Flow Centrifugation. Tangential Flow Filtration. Depth Filtration and Clarification. Buffer Preparation and filtration. Operate general production equipment such as Autoclaves, Glass washers, Incubators, Scales, pH/conductivity meters, etc. Assist in writing standard operating procedures and batch production records in accordance with SOPs. Document and maintain activity records according to cGMP regulations. Maintain the confidentiality of proprietary company information. Perform daily cleaning and sanitization of the laboratory. Maintain effective working relationships with others. Perform all other duties as assigned. Required Skills & Abilities: Good oral and written communication skills, interpersonal and organizational skills. Strong proficiency with Microsoft Office applications. Good self-discipline and attention to detail. Must have flexible work hours - must be willing to work outside of normal scheduled hours as necessary including opportunities for overtime. Good math and computer skills. Must possess good planning and time-management skills and be willing and able to interface with colleagues in various roles and functions throughout the manufacturing facilities. Working Conditions & Physical Requirements: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to: Experience prolonged standing, some bending, stooping, pushing, pulling, reaching above shoulders and stretching. Use of hand-eye coordination and manual dexterity sufficient to operate in a laboratory and/or manufacturing environment. Lift up to 25 pounds frequently and up to 50 pounds occasionally. Attendance is mandatory. Minimum Qualifications: Associates degree preferably in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or other related field; OR High School Diploma/GED with 1 year of work experience. Preferred Qualifications: Experience in a GMP environment Biotechnology Certificate Job Requirements:

Overview Summary : The Senior Manufacturing Lead - Downstream will lead a team and work directly with a range of purification technologies including: filtration technologies (TFF and depth), chromatographic separations (Single Use GE AKTA systems), viral inactivation, etc. following aseptic techniques and procedures in a cGMP environment. External US Essential Functions: Responsible for leading a team in the operation of chromatographic systems (Single Use GE AKTA). Responsible for coordinating daily manufacturing floor activities. Responsible for overseeing and preparing and formulating buffers in accordance to procedures. Responsible for writing, reviewing, and/or updating Standard Operating Procedures (SOPs) and Batch Production Records (BPRs). Document and maintain activity records according to cGMP regulations and ensure team members are properly trained on all proper processes. Coordinate and implement project safety and quality assurance programs in collaboration with senior staff and EH&S. Ensure proper documentation and execution of Batch Production Records for assigned projects. Maintain confidentiality of proprietary company information. Participate in and/or lead incident investigations. Maintain an effective working relationship with others. Perform all other duties as assigned. NCTM/Building 200 Essential Functions: Operation and familiarity with the following systems: Large-scale filtration systems including Tangential Flow Filtration (TFF) and depth filtration. Large-scale centrifugation systems including Sucrose Density Centrifugation, Continuous Flow Centrifugation, and Clarification. Large-scale Chromatographic systems (ÄKTA) Lead team in continuous flow centrifugation, sucrose gradient separation, various filtration technologies, chromatographic separations technologies, and viral inactivation following aseptic technique in a cGMP environment. Provide input and support to Process Development functions during development and scale up activities as necessary. Building 100 Essential Functions: Ability to use and train employees with single use systems. Ability to operate and train employees on general production equipment such as Incubators, Analytical Scales, pH/conductivity meters, etc. Lead team on ultrafiltration using single use technology and aseptic final fill execution. Required Skills & Abilities: Excellent oral and written communication skills as well as excellent interpersonal and organizational skills. Demonstrated leadership skills. Ability to train others to perform and maintain cGMP standards Strong proficiency with Microsoft Office applications. Experience working in cleanroom environments. Must have flexible work hours, and be willing to work outside of normal, scheduled hours, as necessary. Must be able to work alternative shift hours and weekends as required. Self-discipline and good attention to detail. Excellent math and computer skills. Must have exceptional planning skills and be willing to interface with colleagues in many different roles and functions throughout the manufacturing facilities and lead projects. Working Conditions & Physical Requirements: The physical demands described here are representative of those that must be met by an employee, in order to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. While performing the duties of this job, the employee is required on a regular basis to: Experience prolonged standing, some bending, stooping, and stretching. Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Ability to lift up to 25 pounds; frequently, and up to 50 pounds; on occasion. Attendance is mandatory. Qualifications: Master's Degree preferably in Biology, Microbiology, Chemistry, Biochemistry, Engineering or related field with 3 years relevant experience of which 2 years must be in a GMP environment; OR Bachelor's Degree preferably in Biology, Microbiology, Chemistry, Biochemistry, Engineering or related field with 5 years relevant experience of which 2 years must be in a GMP environment; OR Associates Degree preferably in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or related field with 7 years relevant experience of which 2 years must be in a GMP environment. High School Diploma or Associates Degree preferably in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or related field with 9 years relevant experience of which 2 years must be in a GMP environment. Experience with Mammalian Cell or Insect Cell, Yeast or Bacterial Cell lines. Preferred Qualifications: Six Sigma Certification Job Requirements: