Technical Expert, ACMF, Downstream
The clinical manufacturing technical expert is part of a multi-disciplinary team responsible for cGMP production of phase I/II clinical drug substance supporting the Pfizer Biotherapeutics portfolio.
Initial focus is on the start-up of a new facility in support of facility/equipment commissioning and qualification, creation of necessary cGMP documentation, and training within the production support area.
Post facility start up, the successful candidate will be a part of a team responsible for the execution of Downstream mammalian and microbial processes
ROLE RESPONSIBILITIES
- Execute downstream mammalian and microbial TFF and chromatography processes in a cGMP environment. Includes SIP and CIP operations.
- Leads troubleshooting activities and elevate issues to process engineer as necessary.
- Execute and leads product change over activities with the guidance of process engineer and tech transfer team.
- Execution of SOP’s and batch record documentation of downstream unit operations.
- Cross-functional communication with tech transfer team, quality and engineering as necessary.
- Cross-shift communication with 1st shift. Actively participates in shift changeover activities and communication channels.
- Active participant of the OWN IT culture. Identifies and supports continues improvement needs. Utilizes continues improvement and root cause analysis tools ( 5S and DMAIC)
- Maintains a safe work environment.
- Effectively uses process automation systems (i.e. Delta V and OSI/Pi Historian) and supporting business systems (i.e. Microsoft Dynamics/SAP/ERP Systems, Trackwise, Document Management Systems, Microsoft Sharepoint etc.)
Basic Qualifications
- HS diploma, Associates Degree, or BS/BA in Biotechnology, Microbiology, Cell Biology, Chemical Engineering, Biochemistry or equivalent.
- Requires a minimum 5+ years of experience in a biotechnology manufacturing or laboratory environment.
Preferred Qualifications
- Prior experience in a Biological Pilot Plant, cGMP Clinical or Commercial Manufacturing setting
- Prior experience of mammalian and/or microbial chromatography and TFF processes.
- Experience with Production Control Systems (i.e. DeltaV), ERP Systems (i.e. Microsoft Dynamics and/or SAP) and other business systems (Document Management Systems, LIMS, Microsoft Word, Excel, etc.)
- Experience with Quality Management and Change Management Systems (i.e. Trackwise)
- Ability to follow Standard Operating Procedures and work under minimal supervision.
- Strong mechanical aptitude and ability to interface with computerized systems required.
- Demonstrated capability to work as a team member in a matrix manufacturing team.
- Excellent oral and written communication skills
PHYSICAL/MENTAL REQUIREMENTS
- Must be able to climb flights of stairs, and be standing for ~1-2 hours at a time.
- Must be able to lift up to 25lb
- Practical knowledge of the use of Personal Protective Equipment (PPE) to handle hazardous materials throughout site
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- Ability to work day shift (Occasional Weekends) as needed; non-routine
- Ability to work in a clean room environment
PHYSICAL/MENTAL REQUIREMENTS
- Job requires working in a cleanroom environment
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- Some weekend, off shift, and overtime work required
Other Job Details:
- Last Date to Apply for Job: January 26, 2021
- Eligible for Employee Referral Bonus: YES