(CW) Manufacturing Associate (Temporary/Contract)

Duties

• Understanding of process theory and equipment operation.
• Ability to learn biopharmaceutical manufacturing processes including mammalian cell culture, depth filtration, tangential flow filtration, column chromatography, centrifugation, protein purification, and formulation of bulk drug substance.
• Support initiatives for process optimization.
• Identify and elevate processing issues and support solutions.
• Gain experience with automation systems (LIMS, MES, PI, etc.).

Technical Documentation

• Provide feedback and/or suggested changes to operational procedures.
• Absorb and incorporate new technologies, practices, and standards into procedures.
• Capable of writing and reviewing process documents.

Quality and Compliance

• Understanding of cGMPs as related to Commercial Operations.
• Utilize Quality systems (Deviations, CAPAs, Change Requests, Action/Alert Reports, etc.).

Business

• Ability to participate on projects and contribute to outcomes.
• Learn and support new business systems (Track wise, ERP, etc.).
• Support trending of defined department metrics.