1+ months

Team Leader, Clinical Manufacturing (2nd Shift)

Pfizer
Andover, MA 01810
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**ROLE SUMMARY**

The clinical manufacturing manager is part of a multi-disciplinary team responsible for cGMP production of phase I/II clinical drug substance supporting the Pfizer Biotherapeutics portfolio.



The successful candidate will lead a 2nd shift a team of 5-7 colleagues responsible for the operation, troubleshooting, and data analysis of microbial fermentation and purification processes.



Focus for the initial assignment is on the shakedown and start-up of two production suites and hiring of staff in support of microbial fermentation operations.



**ROLE RESPONSIBILITIES**



+ Perform the operation and lead troubleshooting of manufacturing equipment and control systems used in the manufacture of biopharmaceuticals

+ Responsible for in plant manufacturing operations, production support or process technology transfer to ensure the on time delivery of high quality drug substance for clinical use.

+ Direct reporting and career development responsibility for a team of 5-7 engineers and/or technicians.

+ Lead troubleshooting of manufacturing equipment and control systems. May perform operations as needed.

+ Lead/Support the design and qualification of new equipment or system improvements, changes, or upgrades.

+ Strong bioprocess knowledge required to provide guidance or direction for team and effectively communicate and/or escalate process related issues.

+ Coordination of team activities and scheduling of operations with other area managers.

+ Cross functional collaboration with BRD lab scientists, Quality Unit, site and network manufacturing facilities, and Engineering on interdepartmental and cross site initiatives.

+ Lead team through product changeover activities

+ Support all investigations and audits as needed.

+ Provide off-shift and on call support when necessary.



**BASIC QUALIFICATIONS**



+ BS or MS in a biological or engineering discipline (Biotechnology, Biochemistry, Biochemical Engineering, or equivalent)

+ 5+ years of experience in biologics process development, technology transfer, pilot or manufacturing required.



**PREFERRED QUALIFICATIONS**



+ Understanding of upstream/downstream cell culture and/or fermentation is strongly desired.

+ Demonstrated capability to work across functional areas such as development, maintenance, quality and regulatory.

+ Good communication skills, verbal and written, are required.

+ Experience in a cGMP environment with increasing responsibility is desired.Management experience is also highly desirable.

+ Working knowledge of automated production systems with ability to manipulate and troubleshoot systems.



**ADDITIONAL OFFER DETAILS**



+ **Last Day to Apply: October 15, 2019**

+ Additional Location Information: Andover, MA

+ Eligible for Employee Referral Bonus: Yes



**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.



**\#LI-PFE**

N (Other) (United States of America)

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Posted: 2019-09-05 Expires: 2019-11-09

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Team Leader, Clinical Manufacturing (2nd Shift)

Pfizer
Andover, MA 01810

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