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ROLE SUMMARY

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

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Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Manufacturing

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