26 days old

Sr. Manager, Gene Therapy Technical Services External Supply

Pfizer
Sanford, NC 27330
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**ROLE SUMMARY**

As a member of the Gene Therapy Manufacturing Technical Services team (MTS), the Senior Manager will support process transfers and process validation of Pfizer Gene Therapy products manufactured at CMOs partners. During commercial production the incumbent will serve as technical leader on the virtual site operations team.



**ROLE RESPONSIBILITIES**



+ Supports Process Validation of Gene Therapy processes at the CMOs: participates in risk assessments, contributes to the design of PV strategy, PPQ protocols and auxiliary process validation activities; reviews and approves technical studies, protocols and reports

+ Serves as a Person in the Plant (PIP) during PPQ batches execution

+ Serves a technical SME supporting deviations and process related change controls

+ Serves as a Technical Leader on the Virtual Site operations Team

+ Conducts oversight activities as a technical assessor of CMO capabilities and performance

+ Proactively manages technical support for suppliers and CMOs in concert with ESQ colleagues

+ Cultivate strong relationship with CMOs



**QUALIFICATIONS**



**Required**



+ BSc in a scientific/technical discipline of the life sciences such as biochemistry, biology, biochemical engineering or similar

+ 10+ years of experience in scientific / technical roles within the biotech industry, supporting transfer, process validation and commercialization of biotech products

+ Advanced technical expertise in a number of the following areas: mammalian cell culture, virology, downstream technologies, analytical sciences

+ Experience in taking major process and method changes through to the regulatory filing stage for marketed biologics

+ Proficient user of problem-solving, risk analysis and statistical tools

+ Hands-on familiarity with drug regulations/regulatory processes and quality/GMP/compliance systems of the pharmaceutical industry

+ Demonstrated record of success in leading process transfers to CMOs

+ Excellent communication skills (verbal + written).

+ Ability to matrix-work effortlessly across team and organizational / hierarchical boundaries.



**Preferred**



+ Master or PhD degree is preferred

+ Ability to effectively manage and influence global cross functional teams

+ Proven project management and complex problem solving skills

+ Demonstrated leadership with proven success in challenging status quo

+ Strong organizational and planning skills, as well as a high energy level and initiative

+ Experience with Gene therapy processes is a plus



+ **Last Date to Apply for Job** **: 5 /13/2020**

+ Eligible for Employee Referral Bonus

+ Eligible for Relocation Package



**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.



Engineering
Posted: 2020-04-30 Expires: 2020-05-31
Sponsored by:
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Sr. Manager, Gene Therapy Technical Services External Supply

Pfizer
Sanford, NC 27330

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