Manufacturing Associate

Title: Manufacturing Associate

Location: Novato, CA

Contract: 12 months

Candidates must be flexible with their schedule.

Positions may be 5 x 8 hour shift, 4 x 10 hour shift, 3 x 12 and 4x12 hour shift. Manufacturing operations are 24/7, so this requires multiple off shift coverage. Candidates need to be open to work any shift. 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.

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
• Operate large scale bioprocess equipment for the Cell Culture and Purification operations.
• Prepare Buffer and Media solutions.
• Perform all aspects of processing: preparation of equipment, disassembling equipment, assembling process equipment, perform CIP and SIP of equipment, perform pressure tests of equipment, perform I Testing of filters, calibration and use of analytical equipment.
• Display competency with process equipment and automated control systems
• Knowledge of biotech manufacturing process and equipment including cell culture, depth and tangential flow filtration, column chromatography, protein purification and formulation and/or buffer and media operations.
• Proficiency with compliance; adherence to standard operating procedures, batch record, good documentation practices and data capturing

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

Education & Qualifications:

• 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
• 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