Team Lead, Clinical Manufacturing - Andover, United States - Pfizer

Pfizer

Verified Company

Andover, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

Why Patients Need You

Our breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing team.

We rely on a team of dedicated and agile members, who understand the importance and impact of their role in Pfizer's mission.

Patients need colleagues like you who take pride in their work and always look to improve outcomes. You will help to ensure that patients and physicians have the medicines they need, when they need them.

What You Will Achieve

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 8 colleagues responsible for the operation, troubleshooting, and data analysis of microbial fermentation, mammalian cell culture and purification processes.

This role is a 2nd shift position.

How You Will Achieve It- Manage production operations and process technology transfer within the upstream and downstream operational area 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 8 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.- 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.

Qualifications:

Must-Have- Bachelor's 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 mammalian cell culture, 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 upstream/downstream cell culture and/or fermentation.- Proven ability to troubleshoot complex processing issues and ability to make decisions with mínimal 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.

Nice-to-Have- Excellent time management and multi-tasking skills.- Ability to work under mínimal supervision.

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 is a 2nd shift position (2:30pm - 11:00pm).- Ability to work off shift (Nights and Weekends) as needed; non-routine- Ability to work in a clean room environment

Other Job Details:

Work Location Assignment: On Premise
On Premise colleagues work in a Pfizer site because it's needed to get their job done. They may have flexibility to work remotely from time to time, but they are primarily onsite

Relocation assistance may be available based on business needs and/or eligibility.
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