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Manager

Pfizer


Location:
Sanford, NC
Date:
02/09/2018
2018-02-092018-03-12
Pfizer
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Job Details

**ROLE SUMMARY**



As a member of the Gene and Cell Therapy Manufacturing Technical Services Team located in Sanford, NC, the Manager- Upstream Process s 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 a multi-project late phase clinical and commercial portfolio and make strong technical contributions to multi-disciplinary/ cross-functional project teams so as to ensure efficient and timely execution of process transfers, manufacture of late phase clinical batches, commercial launches and providing technical support for ongoing commercial production.







**ROLE RESPONSIBILITIES**







+ Actively contribute to process development, scale-up, transfer cand 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 CMOs



+ Contribute to Project Technical and Co-Development 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







**QUALIFICATIONS**







+ PhD or MS degree in Bioprocessing, Molecular Biology or related discipline



+ 8-12 years of relevant experience in biopharmaceutical industry



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



+ Process development or technical support for GMP manufacturing of gene or cell therapies including experience with single-use bioprocessing technologies such as WAVE bioreactor



+ 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.







**PHYSICAL/MENTAL REQUIREMENTS**







+ No unique physical requirements







Mental:



-Remains organized &; positive in ambiguous and fast-paced, rapidly changing environment



-Flexible and adaptable to changing priorities, meeting deadlines, and working well under pressure and in ambiguous situations



-Ability to process complex information and make recommendations with incomplete data set







**NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS**



Ability to adjust work schedule to meet business needs - overtime, off shift, weekends.



Ability to travel- travel time may be up to 20% according to business needs.







**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.







**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.







**Last Date to Apply for Job:** 22 February, 2018







Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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