24 days old

Senior Process Engineer

Sanford, NC 27330

As a member of the Gene and Cell Therapy Manufacturing Technical Services Team located in Sanford, NC, the Senior Process Engineer - Upstream Process will serve as a technical Subject Matter Expert for upstream process manufacturing of Gene and Cell Therapy products. The successful applicant will provide strong technical and organizational leadership, effectively support verification of a commercial

multi-project late phase clinical and commercial portfolio and make strong technical contributions to multi-disciplinary/ cross-functional project teams. They will ensure efficient and timely execution of process transfers, manufacture of late phase clinical batches, commercial launches and providing technical support for ongoing commercial production startup activities.


+ Actively contribute to scale-up, transfer and successful execution of robust gene therapy products manufacturing processes

+ Drive application of the Right First Time co-development processes for upstream process risk assessments and control strategies

+ Support both late phase clinical and commercial manufacturing operations, including Tech Transfer to the Sanford Facility and facility start up activities

+ Contribute to Project Technical Teams, communicate and collaborate effectively to ensure effective interactions with all stakeholder groups.

+ Designs technical and engineering studies, writes technical reports summarizing study results and generates necessary data to support change impact assessments during process transfer and investigations.

+ Authors process and equipment descriptions, process flow diagrams and risks assessments.

+ Supports change management and implementation for changes to the manufacturing processes and associated systems.

+ Identifies potential process improvements projects. Leads implementation of process improvements projects and supports compliance driven projects that require technical support.

+ Contribute to process validation plans, protocols and reports.

+ Mentor and train junior colleagues



+ 5-8 years experience with BS, 3-5 years with MS or 1-2 years experience with PhD required.

+ Background in molecular biology or mammalian cell culture experience in bio pharmaceutical industry.

+ Process development or technical support for GMP manufacturing with single-use bio processing technologies such as WAVE bioreactor and XDR bioreactors

+ Strong mammalian cell culture expertise required, knowledge of other heterologous expression systems desirable

+ An in-depth knowledge of bioreactor operations and in particular perfusion cell culture highly desirable

+ Process Transfer and Scale up Experience in GMP environment

+ Strong leadership, organizational planning and project management skills, in addition to technical knowledge, is required to work with multi-disciplinary teams.

+ Must be self-motivated and work with minimum direction

+ Excellent interpersonal effectiveness and communication skills (written and oral) are required in order to interface across management levels and departments. Preferred

+ Molecular virology/ engineering and production of recombinant viruses based on transient transfection

+ Perfusion cell culture experience

+ **Last Date to Apply for Job: 5/10/2020**

+ Eligible for Employee Referral Bonus

+ Eligible for Relocation Package

+ \#LI - PFE

**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.



Posted: 2020-04-30 Expires: 2020-05-30

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Senior Process Engineer

Sanford, NC 27330

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