Schedule: Hybrid 2.5 days onsite / Monday - Friday / First Shift
Candidates must be local to MA - Andover site
The 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 facility resides within the Research and Development organization.
The facility Tech Transfer Team is responsible for incoming product site assessment, preparatory activities, campaign readiness, and overall product/project ownership to support facility manufacturing of clinical drug substance.
Job Responsibilities:
Execute tech transfer activities in support of all facility 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
What is the minimum education experience required?
Minimum: BS/BA in Chemical Engineering, Biotechnology, Microbiology, Cell Biology, Biochemistry or equivalent +2 years of experience, or MS + 0 years of experience.