Why Patients Need You
Our breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing team. We rely on a team of dedicated and agile members, who understand the importance and impact of their role in Pfizer’s mission. Patients need colleagues like you who take pride in their work and always look to improve outcomes. You will help to ensure that patients and physicians have the medicines they need, when they need them.
What You Will Achieve
You will be accountable for activities involved in the production of drug substance or active biological ingredients (ABI). You will assist in a wide variety of activities and functions while supporting a manufacturing facility following Good Manufacturing Practices and ensuring compliance with Pfizer Standard Operating Procedures (SOPs) along with all applicable worldwide regulations and guidelines.
As part of technical operations, you will be a team member who is relied to have a good understanding of procedures, techniques, tools, materials and equipment. Your decision making will help you prioritize workflows based on the available resources. You will follow standard procedures to complete tasks, some of which may vary in scope, sequence, complexity and timing. You will contribute to the team’s success by sharing your previously acquired knowledge.
It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
The clinical manufacturing technical expert is part of a multi-disciplinary team responsible for cGMP production of phase I/II/III clinical drug substance as well commercial material in supporting the Pfizer Biotherapeutics portfolio.
Initial focus is on the start-up of processes within a new facility with new equipment, commissioning and qualification of the equipment, creation of necessary cGMP operational documentation, and training within the production environment.
Post facility start up, the successful candidate will be a part of a dynamic 2nd shift team responsible for the execution of Downstream mammalian and microbial processes.
- Manage own time, professional development, prioritize workflows and be accountable for own results.
- 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 change 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 Teams)
- 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.
- 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 and author Standard Operating Procedures and work under minimal supervision.
- Strong mechanical aptitude and ability to interface with computerized systems required.
- Demonstrated capability to lead and work as a team member in a matrix manufacturing team.
- Excellent oral and written communication skills
- 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
- Ability to work 2nd shift (Occasional Weekends) as needed; non-routine
- Ability to work in a clean room environment
- Eligible for Employee Referral Bonus: YES