Job Details

Are you an experienced Manufacturing Associate with a desire to excel? If so, then Talent Software Services may have the job for you! Our client is seeking an experienced Manufacturing Associate to work at their company in Novato, CA.

Primary Responsibilities/Accountabilities:

• 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, 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. 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 science-related area or engineering
• Associate's degree in science science-related area or a Biotech certificate with 2+ years of experience in a biotech manufacturing environment or other regulated industry
• Consists of strenuous, repetitive work. The following list of physical movements may be used on a daily basis: bending, reaching, climbing stairs and ladders, kneeling and making numerous equipment connections using hands.
• Independently have the ability to regularly lift, dispense, push and/or pull items with an average weight of 25 pounds.
• May require working around loud equipment.
• The use of personal protective equipment will be required.
• Requires various shift-based work and off-hours.

Preferred:

• Strong communication skills—verbal and written
• Ability to work in a team environment, which includes good conflict resolution and collaboration
• Displays good initiative to identify areas for improvement and implement solutions