Manufacturing Associate (6-Month Contract)

Location: Novato

Pay Rate: $28/hour

Shift Schedule: Sunday – Tuesday, 6:00 p.m. – 7:00 a.m., with alternating Saturdays

Eligibility: May graduates are welcome to apply

Position Overview

The Manufacturing Associate supports biopharmaceutical production processes, ensuring adherence to quality and compliance standards while contributing to process optimization and operational excellence.

Key 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
• Centrifugation
• Protein purification
• 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 incorporating 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 in projects and contribute to outcomes
• Capability to learn and support new business systems (Trackwise, ERP, etc.)
• Support trending of defined department metrics

Work Environment & Physical Demands

• Consists of strenuous, repetitive work
• Daily physical activities may include:
• Bending, reaching, climbing stairs and ladders, kneeling
• Making numerous equipment connections using hands
• Ability to independently lift, dispense, push, and/or pull items averaging 25 pounds
• May require working around loud equipment
• Use of personal protective equipment is required
• Requires shift-based work and off-hours

Required Skills

• Strong verbal and written communication skills
• Ability to work in a team environment, including conflict resolution and collaboration
• Demonstrates initiative to identify areas for improvement and implement solutions

Education Requirements

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