Manufacturing Associate (Pharmaceuticals)

Pharmaceuticals company in Novato, California is hiring a few Manufacturing Associates to join the department to support drug development manufacturing. The manufacturing facilities operates 24/7 and would need multiple shift coverage. Shift differential pay may be available to the Manufacturing Associate depending on the shift offered at the time of the job offer.

Duration: 6-month contract

Shift: 6:00 AM to 7:00 PM —Thursday to Saturday, alternating Wednesdays

Responsibilities

• Process Knowledge:
• Understanding of process theory and equipment operation.
• Ability to learn biopharmaceutical manufacturing processes including mammalian cell culture, depth filtration, tangential flow filtration, column chromatography, protein purification and formulation of bulk drug substance.
• Support initiatives for process optimization.
• Identify and elevate processing issues and support solutions.
• Demonstrated proficiency Gain experience with automation systems (LIMS, MES, PI, etc.).
• Technical Documentation:
• Provide feedback and/or suggested changes to operational procedures.
• Assist in the incorporation of 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.
• Ability to utilize Quality systems (Deviations, CAPAs, Change Requests, Action/Alert Reports, etc.)
• Business:
• Ability to participate on projects and contribute to outcomes.
• Capability to learn and support new business systems (Track wise, ERP, etc.).
• Support trending of defined department metrics.

Qualifications

• Bachelor's degree in science related area or engineering OR Associate’s degree in science related area OR Biotech certificate with 2+ years of experience in a biotech manufacturing environment or other regulated industry.