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Team Leader, Upstream Clinical Manufacturing (2nd Shift)

Pfizer


Location:
Andover, MA
Date:
12/20/2017
2017-12-202018-01-20
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 Upstream Clinical Manufacturing area Team Leader 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 during 1st shift hours with accountability to ensure compliance with Pfizer specifications during the facility/equipment commissioning and qualification, and the creation of all necessary cGMP documentation.







Post facility start up, the successful candidate will transition to 2nd shift to lead a team of 5-7 colleagues responsible for the operation, troubleshooting, and data analysis of upstream mammalian and microbial fermentation processes.







**ROLE RESPONSIBILITIES**







+ 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.



+ Perform on the floor commissioning and startup of operations equipment



+ Lead/Support the design and qualification of improvements, changes, or upgrades to this equipment as needed



+ 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 tech transfer activities for new products and product changeovers.



+ Support all investigations and audits as needed.



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



+ 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.







**BASIC QUALIFICATIONS**







+ BS or MS in a biological or engineering discipline (Biotechnology, Biochemistry, Biochemical Engineering, or equivalent) with 5+ years experience in biologics process development, technology transfer, pilot or manufacturing required. Understanding of upstream 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



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







**NON-STANDARD WORK REQUIREMENTS**







+ This is a 2nd shift position, however during commissioning and start up, the candidate will work 1st shift hours. Once the facility is operational, the candidate will transition to 2nd shift.



+ Ability to work off shift (Nights and Weekends) as needed; non-routine



+ Ability to work in a clean room environment







**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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