Manufacturing Associate

BioTalent; Tustin (CA); On-site; USD 28,000 - 39,000; Full time

Job summary

BioTalent in Tustin, CA is seeking Manufacturing Associates with upstream biology experience for a fully onsite role. The position supports upstream operations in a cGMP environment and offers exposure to both commercial and clinical manufacturing activities.

Applicants should have hands-on upstream manufacturing/cell culture experience, familiarity with GMP/cGMP, and strong documentation skills. Priority shifts include 5:00 PM–2:00 AM, Monday–Friday, with additional schedules possible.

Qualifications

• Experience in biotechnology, biopharmaceutical, or biologics manufacturing.
• Hands-on upstream manufacturing / cell culture experience.
• GMP/cGMP-regulated environment experience.

Responsibilities

• Support upstream biologics manufacturing operations in a cGMP environment.
• Work with upstream processes such as cell culture, media/buffer prep, bioreactors, seed train, sampling, and related activities.
• Execute manufacturing processes per SOPs, batch records, and GMP requirements.
• Complete accurate and timely GMP documentation.
• Support equipment prep, cleaning, setup, and manufacturing activities.
• Collaborate with Manufacturing, Quality, MSAT and cross-functional teams.
• Assist with troubleshooting, investigations, and continuous improvement.
• Maintain a safe, compliant, inspection-ready manufacturing environment.

Skills

Upstream manufacturing

Cell culture

GMP documentation

SOP adherence

Biologics manufacturing

Team collaboration

Job description

Tustin, California | Fully Onsite

I'm currently looking for Manufacturing Associates with Upstream experience to join our company, a leading biologics CDMO supporting the development and manufacturing of life-saving biopharmaceuticals.

This is a great opportunity for candidates looking to continue building their careers in biologics manufacturing within a cGMP environment, with exposure to commercial and clinical manufacturing operations and strong opportunities for professional growth.

What you'll be doing:

• Supporting upstream biologics manufacturing operations in a cGMP environment
• Working with upstream processes such as cell culture, media/buffer preparation, bioreactors, seed train operations, sampling, and related manufacturing activities
• Executing manufacturing processes according to SOPs, batch records, and GMP requirements
• Completing accurate and timely GMP documentation
• Supporting equipment preparation, cleaning, setup, and manufacturing activities
• Collaborating with Manufacturing, Quality, MSAT, and other cross-functional teams
• Supporting troubleshooting, investigations, and continuous improvement activities as needed
• Maintaining a safe, compliant, and inspection-ready manufacturing environment

We're especially interested in candidates with:

• Experience in biotechnology, biopharmaceutical, pharmaceutical, or biologics manufacturing
• Hands-on upstream manufacturing / cell culture experience
• Experience working in a GMP/cGMP-regulated environment
• Familiarity with bioreactors, aseptic processing, cell culture, single-use systems, or related upstream equipment
• Strong documentation skills and attention to detail
• Ability to work effectively in a highly regulated, team-oriented manufacturing environment

Priority Shift: 5:00 PM - 2:00 AM, Monday through Friday

We are prioritizing candidates who are open to the 5 PM-2 AM shift. If this schedule doesn't work for you, I'd still love to hear from you, as additional Manufacturing Associate schedules may be available, including alternative weekday/weekend schedules.

Why consider our company?

This is an opportunity to join an established biologics manufacturing organization where you can gain valuable hands-on experience, expand your technical manufacturing skills, and continue growing within the biopharmaceutical industry.

And if you know someone with Upstream Biologics Manufacturing experience in Southern California, feel free to share or tag them!

Please note that this position is fully onsite in Tustin, California, and relocation assistance is not available. We are prioritizing candidates who are currently located in Tustin, Orange County, or within a reasonable commuting distance.

Work Authorization:

• U.S. Citizens and Green Card holders are welcome to apply.
• Candidates currently authorized to work in the U.S. through F-1 OPT may also be considered.
• Employer-sponsored visa sponsorship, visa transfers, or future sponsorship are not available for this position.

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