Manufacturing Associate

Manufacturing Associate

Duration: 6+ Months

Location: Novato CA 94949

Payrate: $25-$28/HR on w2 plus shift differential

Shift schedule:

06:00 PM to 07:00 AM

06:00 AM to 07:00 PM

Shift differential for 2nd shift: 10%

Shift differential for 3rd shift: 15%

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:

• Strong communication skillsverbal 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

Education:

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

Regards

Namrata Goel

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