Upstream Manufacturing Associate
Position Summary
We are seeking a motivated Upstream Manufacturing Associate to join our biopharmaceutical manufacturing team. This entry-level position supports the production of biologic drug substances through upstream manufacturing processes in a cGMP-regulated environment. The ideal candidate is a recent graduate with a strong scientific background who is eager to begin a career in biopharmaceutical manufacturing.
Key Responsibilities
Perform upstream manufacturing activities including media and buffer preparation, cell culture support, and bioreactor operations.
Execute manufacturing processes according to batch records, standard operating procedures (SOPs), and cGMP requirements.
Operate, monitor, clean, and maintain manufacturing equipment and process systems.
Accurately complete batch records and manufacturing documentation in accordance with Good Documentation Practices (GDP).
Monitor critical process parameters and report any deviations or equipment issues.
Assist with equipment setup, sanitization, and routine maintenance activities.
Maintain a clean and organized manufacturing environment while following safety and contamination control procedures.
Collaborate with Manufacturing, Quality Assurance, Quality Control, and Engineering teams to support production goals.
Participate in training programs and continuously develop technical knowledge of upstream bioprocessing.
Minimum Qualifications
Bachelor's degree required in Biology, Chemistry, Biochemistry, or a closely related Life Science discipline.
No prior industry experience required. Recent graduates are encouraged to apply.
Basic understanding of cell biology, microbiology, biochemistry, or laboratory techniques gained through coursework or academic laboratory experience.
Strong attention to detail and ability to follow written procedures.
Excellent communication and teamwork skills.
Ability to work in a fast-paced, regulated manufacturing environment.
Basic computer proficiency, including Microsoft Office.
Preferred Qualifications
Academic laboratory experience with cell culture, microbiology, or biochemistry.
Knowledge of cGMP, aseptic techniques, or biopharmaceutical manufacturing principles through coursework or internships.
Experience using laboratory equipment such as balances, pH meters, pipettes, or analytical instruments.
Physical Requirements
Ability to stand for extended periods during manufacturing operations.
Ability to lift up to 35 pounds.
Ability to wear required personal protective equipment (PPE), including cleanroom gowning.
Ability to work flexible schedules, including weekends or holidays, as production needs require.
Upstream Manufacturing Associate • Tustin, CA, US
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