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Senior Manager, Clinical Manufacturing Technical Transfer

Pfizer


Location:
Andover, MA
Date:
12/22/2017
2017-12-222018-01-22
Pfizer
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Job Details

A career at Pfizer offers opportunity, ownership and impact. All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.







The clinical manufacturing technology transfer manager 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 with accountability to ensure compliance with Pfizer specifications during the facility/equipment commissioning and qualification, and the creation of all necessary cGMP documentation and work processes.







Post facility start up, the successful candidate will lead a team of 4-6 colleagues responsible for the technology transfer of mammalian and microbial fermentation processes.







**ROLE RESPONSIBILITIES**







+ Responsible for leading team to develop process technology transfer work processes as part of facility start up.



+ Oversight of technology transfer team in support of all early phase clinical pipeline. Potential support of technology transfers to contract manufacturing facilities.



+ Direct reporting and career development responsibility for a team of 4-6 engineers.



+ Lead team in troubleshooting process related issues in collaboration with operations group and lab scientists.



+ 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.



+ Support of product changeovers.



+ Support all investigations and audits as needed.



+ The manager will provide oversight to direct reports, and interact with a cross-functional team including engineering, quality, supply chain, and Bioprocess R&D Development Labs.



+ Responsible for the management, career development and performance of 4-6 engineers/scientists.







**BASIC QUALIFICATIONS**







+ BS or MS in a biological or engineering discipline (Biotechnology, Biochemistry, Biochemical Engineering, or equivalent) with 10+ years experience in biologics process development, technology transfer, pilot or manufacturing required.



+ 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 computers and associated applications such as MS Word, Excel, and PowerPoint are recommended.







**ADDITIONAL OFFER DETAILS**







+ **Last Date to Apply for Job: February 1, 2018**



+ Additional Location Information: Andover, MA



+ Eligible for Employee Referral Bonus: Yes







**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.







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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