Tech Transfer Engineer in Andover, MA

Schedule: Hybrid 2.5 days onsite / Monday – Friday / First Shift

Candidates must be local to MA - Andover site

The Tech Transfer Engineer II will be joining the Client Andover Clinical Manufacturing Facility (ACMF) team.

• The ACMF is a facility located on the Client Andover, MA campus and is responsible for cGMP production of phase I/II clinical drug substance supporting the Client 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.

Job Responsibilities:

• 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 SOP’s 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 and author investigations as needed
• Support facility audits as needed

Minimum:

• BS/BA in Chemical Engineering, Biotechnology, Microbiology, Cell Biology, Biochemistry or equivalent +2 years of experience

or

• MS + 0 years of experience.

Preferable:

• BS/BA +3-5 years, MS +1-2 years

• Minimum: BS/BA in Chemical Engineering, Biotechnology, Microbiology, Cell Biology, Biochemistry or equivalent +2 years of experience, or MS + 0 years of experience.
• preferable: BS/BA +3-5 years, MS +1-2 years

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