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Manufacturing Associate - 2nd Shift
Ref No.: 18-08667
Location: Novato, California
Schedule Notes
Positions may be 5 x 8 hour shift, 4 x 10 hour shift, or 3 x 12 hour shift. Operations are 24/7, so position may be for any one of several shift schedules. Shifts will be discussed at interviews. Please note candidates will receive weighted overtime for the 2nd shift (10% extra) and the 3rd shift (15% extra). Manufacturing Associates must have a degree or 1-2 years of manufacturing experience and the pay rate is firm at (USD)22.75 for all candidates to ensure internal pay equity.
WORK ENVIRONMENT/PHYSICAL DEMANDS
• Consists of strenuous, repetitive work. The following list of physical movements maybe 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
Operate large scale bioprocess equipment for the cell culture and purification processing
Perform all aspects of processing with a broad understanding of science, compliance and technical aspect
Display competency with process equipment and automated control systems
Perform cleaning and sterilization of parts and equipment used with manufacturing process
Broad knowledge of biotech manufacturing process and equipment including cell culture, depth and tangential flow filtration, column chromatography, protein purification and formulation
Ability to understand, apply, and evaluate basic chemistry, biology and scientific principles as appropriate for the position
Proficiency with compliance; adherence to standard operating procedures, batch record, good documentation practices and data capturing

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
Broad knowledge of biotech manufacturing process and equipment including cell culture, depth and tangential flow filtration, column chromatography, protein purification and formulation
Ability to understand, apply, and evaluate basic chemistry, biology and scientific principles as appropriate for the position