Job Details

Manufacturing Associate

  2025-12-17     Insync Staffing     Novato,CA  
Description:



Shift & Schedule

  • Rotating 12-hour night shift from 6:00 PM – 7:00 AM

  • Wednesday–Saturday, with alternating Saturdays

Compensation & Duration

  • Pay Range: $27.00–$28.00 per hour

  • Assignment: 6-month contract with potential extension or conversion to permanent


Role Overview

The Biotech Manufacturing Associate supports commercial biopharmaceutical manufacturing operations by executing process activities, maintaining compliance with cGMP standards, and contributing to continuous improvement initiatives within a regulated environment.


Key Responsibilities

Process Knowledge & Operations

  • Learn and apply biopharmaceutical manufacturing processes, including:

    • Mammalian cell culture

    • Depth filtration

    • Tangential flow filtration

    • Column chromatography

    • Centrifugation

    • Protein purification

    • Bulk drug substance formulation

  • Operate manufacturing equipment in accordance with procedures and safety requirements

  • Support process optimization initiatives

  • Identify, escalate, and assist in resolving process-related issues

  • Gain hands-on experience with automation systems such as LIMS, MES, and PI

Technical Documentation

  • Provide feedback and recommend updates to operational procedures

  • Assist with integrating new technologies, practices, and regulatory standards into documentation

  • Write, review, and maintain process-related documents

Quality & Compliance

  • Follow cGMP requirements related to commercial manufacturing operations

  • Utilize Quality systems including:

    • Deviations

    • CAPAs

    • Change Requests

    • Action and Alert Reports

  • Maintain compliance with internal procedures and regulatory expectations

Business & Continuous Improvement

  • Participate in cross-functional projects and contribute to defined outcomes

  • Learn and support business systems such as TrackWise and ERP platforms

  • Assist with trending and tracking departmental performance metrics


Work Environment & Physical Requirements

  • Perform strenuous and repetitive tasks, including bending, reaching, kneeling, climbing stairs and ladders, and making frequent equipment connections

  • Regularly lift, push, pull, or dispense materials averaging 25 pounds

  • Work in environments with loud equipment

  • Wear required personal protective equipment (PPE)

  • Support shift-based work schedules, including off-hours as needed


Required Skills

  • Strong verbal and written communication skills

  • Ability to work effectively in a team environment with strong collaboration and conflict-resolution skills

  • Demonstrated initiative to identify improvement opportunities and implement solutions


Education & Experience

  • Bachelor's degree in a science-related field or engineering
    OR

  • Associate's degree in a science-related field or Biotech certificate with 2+ years of experience in biotech manufacturing or another regulated industry


Benefits (employee contribution):
  • Health insurance
  • Health savings account
  • Dental insurance
  • Vision insurance
  • Flexible spending accounts
  • Life insurance
  • Retirement plan

All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.


We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment-qualified applicants with arrest and conviction records. For Los Angeles, CA applicants: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act

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