1+ months

Team Lead, Clinical Manufacturing (3rd Shift)

Pfizer
Andover, MA 01810
Apply Now
Apply on the Company Site
**ROLE SUMMARY**



The Team Lead, Clinical Manufacturing is part of a multi-disciplinary team responsible for cGMP production of phase I/II clinical drug substance supporting the Pfizer Biotherapeutics portfolio. The position is located in Andover, MA.



The Team Lead, Clinical Manufacturing will manage a team of 5-7 colleagues responsible for biologics manufacturing operations inclusive of fermentation, purification, buffer preparation, equipment cleaning and autoclave operations. This role is a 3rd shift position.



**ROLE RESPONSIBILITIES**



+ Manage production operations across upstream, downstream and production support operational areas which includes the process, people, equipment, and documents, to ensure safe and quality drug substance is produced to support clinical trials.

+ Manages a team of 5-7 Technicians. Recruits and retains qualified, dedicated colleagues; promotes a collaborative culture that aligns with corporate culture; Grows, develops and establishes a cohesive team that is inspired, engaged and has key competencies needed. Creates and acts on succession plan.

+ Handles troubleshooting of manufacturing equipment and control systems within assigned operational area. May perform operations as needed.

+ Provides guidance or direction for team and effectively communicate and/or escalate process related issues for assigned operational area.

+ Coordinates weekly production operations schedule for assigned operational area to ensure trained colleagues, documents and equipment are available to meet production deliverables.

+ Cross functional collaboration with Quality Unit and Engineering for assigned operational area.

+ Manages product changeover activities within assigned operational area.

+ Supports all investigations and audits within assigned operational area as needed.

+ Provide off-shift and on call support within assigned operational area when necessary.



**BASIC QUALIFICATIONS**



+ Bachelors degree in a biological or engineering discipline +5 years of experience; Associates degree or completion of 2 years of undergraduate work + 7 years of experience; or HS diploma + 9 years of experience in a cGMP Clinical, Commercial Manufacturing, and/or non-cGMP Pilot Manufacturing setting with in depth expertise of common biotechnology processes and/or API small molecule processes including microbial fermentation, associated purification steps, and drug product/drug substance manufacturing.

+ A minimum of 6 months of people management, matrix leadership or project leadership experience.

+ Understanding of drug substance manufacturing processes.

+ Proven ability to troubleshoot complex processing issues and ability to make decisions with minimal guidance required.

+ Strong verbal and written communication skills.

+ Experienced with electronic systems including QTS (i.e. Trackwise), Documentation, LIMS, ERP (i.e. SAP/Axis 360), Building automation system, MMS/Maintenance, Process Automation systems (i.e. Delta V, Unicorn, Finesse), and other business systems (Microsoft Word, Excel, etc.)

+ Proven ability to make risk-based decisions in a complex/dynamic environment in a timely manner.

+ Experienced in authoring cGMP documentation including SOPs and Batch records.

+ Able to work with cross-functional areas such as quality and engineering in matrix environment.

+ Ability to flex and quickly adapt to changing environment and competing priorities.



**PHYSICAL/MENTAL REQUIREMENTS**



+ Must be able to climb flights of stairs and be standing for ~1-2 hours at a time.



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



+ This position is 3rd shift position

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

+ Ability to work in a clean room environment



**Other Job Details:**



+ Last Date to Apply: November 30, 2021

+ Eligible for Employee Referral Bonus

+ Eligible for Relocation



**\#LI-PFE**



**Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.**



**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.



Manufacturing



\#LI-PFE
Posted: 2021-11-03 Expires: 2022-02-10
Sponsored by:
ADP Logo

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Team Lead, Clinical Manufacturing (3rd Shift)

Pfizer
Andover, MA 01810

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast