Tech Transfer Engineer II

Pfizer • Andover, MA

1d • Hybrid

About The Position

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 Tech Transfer Engineer II will be joining the Pfizer Andover Clinical Manufacturing Facility (ACMF) team. The ACMF is a facility located on the Pfizer Andover, MA campus and is responsible for cGMP production of phase I/II clinical drug substance supporting the Pfizer Biotherapeutics portfolio. The ACMF resides within the Research and Development organization. The ACMF Tech Transfer Team is responsible for incoming product site assessment, preparatory activities, campaign readiness, and overall product/project ownership to support ACMF manufacturing of clinical drug substance. How You Will Achieve Serve as tech transfer lead for incoming projects on a rotating basis (approximately 1-2 per year) When not serving as TT lead, execute tech transfer activities in support of all ACMF campaigns Work with development lines to improve scale up processes and identify best TT practices Partner with development lines on complex technical initiatives Lead/support the creation of manufacturing batch records and other GMP documentation Execute and troubleshoot upstream and downstream processes in a cGMP environment Authorship of SOPs for upstream and downstream unit operations Data analysis and communication/collaboration with tech transfer team, production operations, development labs, and quality Support implementation of new technologies and equipment Support investigations as needed Support facility audits as needed

Requirements

• BS/BA in Chemical Engineering, Biotechnology, Microbiology, Cell Biology, Biochemistry or equivalent +2 years of experience, or MS + 0 years of experience.
• Previous experience in Biologics GMP manufacturing and/or Biologics Tech Transfer

Nice To Haves

• Experience with Tech Transfer, facility fit assessments, and engineering design
• Knowledge of bioprocessing techniques and equipment
• Experience in a GMP manufacturing role
• Experience with Production Control Systems (i.e. DeltaV), ERP Systems (i.e. Microsoft Dynamics and/or SAP) and other business systems (Document Management Systems, LIMS, Microsoft Word, Excel, etc.)
• Ability to execute against SOPs and document entries in a compliant manner
• Demonstrated capability to work as a team member in a matrix manufacturing team
• Excellent oral and written communication skills
• Ability to work under minimal supervision

Responsibilities

• Serve as tech transfer lead for incoming projects on a rotating basis (approximately 1-2 per year)
• When not serving as TT lead, execute tech transfer activities in support of all ACMF campaigns
• Work with development lines to improve scale up processes and identify best TT practices
• Partner with development lines on complex technical initiatives
• Lead/support the creation of manufacturing batch records and other GMP documentation
• Execute and troubleshoot upstream and downstream processes in a cGMP environment
• Authorship of SOPs for upstream and downstream unit operations
• Data analysis and communication/collaboration with tech transfer team, production operations, development labs, and quality
• Support implementation of new technologies and equipment
• Support investigations as needed
• Support facility audits as needed

Benefits

• participation in Pfizer’s Global Performance Plan with a bonus target of 7.5% of the base salary
• 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution
• paid vacation, holiday and personal days
• paid caregiver/parental and medical leave
• health benefits to include medical, prescription drug, dental and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees