Manager, Clinical Manufacturing (1st Shift)
The Manager, Clinical Manufacturing is part of a multi-disciplinary team responsible for cGMP production of phase I/II clinical drug substance the Pfizer Biotherapeutics portfolio. The position is located in Andover, MA.
The Manager, Clinical Manufacturing leads a team of 10 engineers and technical staff responsible for the operation of mammalian cell culture/microbial fermentation and downstream purification processes across various biologics modalities. The Manager leads and/or oversees cross business projects, and partners with process development, lab scientists, Quality Unit, site and network manufacturing facilities, and Engineering to work through investigations and troubleshoot issues.
- Manage upstream and downstream operations and process technology transfer within the clinical manufacturing facility, 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 10 engineers and 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.
- Leads troubleshooting of manufacturing equipment and control systems. May perform operations as needed.
- Leads/Supports the design and qualification of new equipment or system improvements, changes, or upgrades.
- Provides guidance or direction for team and effectively communicates and/or escalates process related issues.
- Owns and manages weekly production operations schedule to ensure trained colleagues, documents and equipment are available to meet production deliverables.
- Partners with development lab scientists, Quality Unit, site and network manufacturing facilities, and Engineering on interdepartmental and cross site initiatives.
- Supports all investigations and audits as needed.
- Provides off-shift and on call support when necessary.
- Bachelors degree in a biological or engineering discipline +7 years of experience; Associates degree or completion of 2 years of undergraduate work + 9 years of experience; or HS diploma + 11 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 mammalian cell culture, associated purification steps, and drug product/drug substance manufacturing.
- A minimum of 1 year of people management, matrix leadership or project leadership experience.
- 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), 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.
- Strong collaboration and partnership skills-able to work across functional areas such as development, maintenance, quality and regulatory functions in matrix environment.
- Ability to flex and quickly adapt to changing environment and priorities.
- Excellent time management and multi-tasking skills.
- Ability to work under minimal supervision
- 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
- 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: October 25, 2021
- Eligible for Employee Referral Bonus
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 ActPfizer 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 EligibilityPfizer 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