Associate Manager Process Sciences – Manufacturing Support
Summary: Responsible to support the Process Sciences Department through Process Validation, manufacturing floor support, product impact assessments, investigations, and technical evaluation as required. Active member of the Process Sciences management team.
Essential Duties and Responsibilities:
Lead a shift team and manage all activities to assure that manufacturing processes are supported. Responsible for developing a team such as development plans, upskilling and team forming.
Provide on the floor support to Manufacturing as part of a shift structure as required.
Lead/Participate Process and Quality risk assessments.
Lead troubleshooting activities associated with the manufacturing process.
Provide technical support for manufacturing personnel to improve understanding of both cell culture and purification operations.
Review and approve manufacturing documentation such as manufacturing records, SOPs and batch sheets.
Develops/writes/plans and reviews protocols and activities for manufacturing support.
Presents and reviews process monitoring data to IOPS Management as necessary.
Investigates and reviews OOS and OOT IPCs investigations.
Will be required to work shift patterns to meet business needs and the production schedule as required
Education and Experience:
Requires a BS/BA in Life Sciences, Biological Sciences or related field with 5+ years of relevant experience in a GMP environment.
Ideal candidate has previous experience in biological drug substance (DS) manufacturing.