Description

Major Responsibilities:

• Perform cGMP cell-based potency assays testing in support of the manufacture of biologics products. Responsible for the timely completion of assigned laboratory testing.

• Generate, compile, and evaluate data for technical reports to support commercial and clinical supplies.

• Review and approve raw data and laboratory logbooks/worksheets.

• Perform cell culture and cell banking.

• Manage critical reagents and supplies.

• Write quality systems records including laboratory investigations, change controls, non-conformances.

• Support regulatory inspections where needed.

• Ensure that all lab equipment is used and maintained correctly. Support lab equipment validation and equipment preventive maintenance.

• Generate and update SOPs.

• Adhere to and supports all EHS standards, procedures and policies.

• Understand regulations and business processes required to maintain laboratory data integrity.

• Maintain and comply with laboratory documentation and computerized systems data integrity requirements.

Incumbent will work to ensure that the company is in compliance with all environmental, health and safety requirements and assure our business practices enhance the welfare of our customers, employees and the community in which we operate.

Skills

gmp environment, bioassay, PCR, automation, quality systems management, microsoft project, aseptic technique, cell culture, cell banking

Top Skills Details

gmp environment,bioassay,PCR,automation,quality systems management,microsoft project

Additional Skills & Qualifications

Qualifications:

• MS in Chemistry/Biochemistry/Cell Biology or a related Biological Science field with 3+ years of relevant industrial experience or BS in Chemistry/Biochemistry/Cell Biology or a related Biological Science field with 5+ years of relevant industrial experience.

• Proficiency in quality systems, Microsoft Project, and Excel.

• Experience in a GMP regulated environment.

• Experience in bioassays, Chemi-ECL ELISA, PCR and automation preferred.

• Experience with aseptic cell culture and cell banking preferred.

Job Type & Location

This is a Contract position based out of Irvine, CA.

Pay and Benefits

The pay range for this position is $45.00 - $47.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Irvine,CA.

Application Deadline

This position is anticipated to close on Feb 18, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.