Biopharmaceutical Manufacturing Associate

Job Description

Upstream, Formulation & Downstream Manufacturing Associate

Location:Tustin, CA
Industry:Biopharmaceutical Manufacturing
Schedule:5:00PM – 2:00AM
Employment Type:Full-Time

Position Summary

A leading biopharmaceutical manufacturing company in
Tustin, CA
is seeking motivated
Manufacturing Associates
to support
Upstream, Formulation, and Downstream manufacturing operations
. These positions are responsible for executing manufacturing activities in a controlled GMP environment while following established procedures, safety requirements, and quality standards.

Multiple shifts are available, including
1st, 2nd, and 3rd shifts
. Candidates with a degree in Biology, Biochemistry, Biotechnology, Microbiology, or another related Life Science discipline are encouraged to apply.

Key Responsibilities

Upstream Manufacturing

• Support cell culture and upstream bioprocessing activities.
• Prepare and stage materials, equipment, and solutions for manufacturing operations.
• Assist with media and buffer preparation.
• Monitor and document manufacturing processes and equipment readings.
• Perform sampling and in-process testing as required.
• Follow SOPs, batch records, GMP requirements, and safety procedures.
• Maintain clean and organized manufacturing areas.
• Accurately document manufacturing activities in accordance with GMP requirements.

Formulation Manufacturing

• Support formulation and preparation of biopharmaceutical products.
• Weigh, measure, and prepare raw materials and components according to approved procedures.
• Operate manufacturing equipment following established SOPs.
• Perform equipment setup, cleaning, and sanitization.
• Conduct in-process checks and sampling.
• Complete batch documentation and manufacturing records accurately.
• Follow aseptic and GMP practices as required.

Downstream Manufacturing

• Support downstream purification and processing activities.
• Assist with filtration, chromatography, centrifugation, and related manufacturing processes.
• Prepare and stage materials and equipment for production.
• Monitor equipment and process parameters.
• Collect and document process samples.
• Perform equipment setup, cleaning, and sanitization.
• Follow SOPs, batch records, GMP requirements, and safety procedures.

Qualifications

• Bachelor's degree in Biology, Biochemistry, Biotechnology, Microbiology, Chemistry, or another related Life Science discipline required.
• Manufacturing, laboratory, pharmaceutical, biotechnology, or biopharmaceutical experience preferred.
• Understanding of basic biological and laboratory principles.
• Ability to accurately follow written procedures and SOPs.
• Strong attention to detail and documentation skills.
• Ability to work effectively in a team-oriented manufacturing environment.
• Ability to work multiple shifts, including evenings, nights, weekends, or overtime as required.
• Ability to work in a controlled/GMP manufacturing environment.
• Strong communication and organizational skills.
• Ability to learn manufacturing equipment, processes, and procedures quickly.

Preferred Experience

• GMP or cGMP experience.
• Biopharmaceutical or pharmaceutical manufacturing experience.
• Cell culture or upstream processing experience.
• Formulation or solution preparation experience.
• Downstream purification experience.
• Experience with batch records and manufacturing documentation.
• Experience working in a cleanroom or controlled manufacturing environment.

Physical Requirements

• Ability to stand and walk for extended periods.
• Ability to wear required PPE and cleanroom garments.
• Ability to lift and move materials and equipment as required.
• Ability to perform repetitive manufacturing activities.
• Ability to work in a controlled manufacturing environment.

Why Join Us?

This is an excellent opportunity for a
Life Science graduate
to build hands-on experience in biopharmaceutical manufacturing and develop expertise across
Upstream, Formulation, or Downstream processing
. Successful candidates will work in a regulated GMP environment supporting the production of high-quality biopharmaceutical products.