Manufacturing Associate

Title : Manufacturing Associate

Location : Novato , CA

Duration : 12 Months

These positions are for the 6pm to 7am shift from Wednesday to Saturday, with every other Saturday off.

Job Description : Duties

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.

WORK ENVIRONMENT / PHYSICAL DEMANDS

• 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 work around loud equipment.
• The use of personal protective equipment will be required.
• Requires various shift-based work and off hours.

Skills

Education