Manufacturing Associate
2 days ago
We are collaborating with a leading biotechnology manufacturer, known for its innovation and commitment to regulatory excellence. Our client is seeking a skilled Manufacturing Associate to support cGMP manufacturing processes in a controlled cleanroom environment.
About the Job
Manufacturing Associate
Location: San Antonio, TX
Position: 6 Month Contract (Extension likely)
As a Manufacturing Associate, you will play a key role in supporting clinical and commercial manufacturing programs, adhering to cGMP standards and regulatory guidelines. You will assist with microbial fermentation, mammalian cell culture, and various downstream processing operations. This role offers an opportunity to contribute to the success of innovative biologic products while working in a collaborative, cross-functional team environment.
Key Responsibilities
- Support daily manufacturing activities for clinical and commercial manufacturing programs.
- Execute and document batch records following Good Documentation Practices (GDP).
- Review and revise SOPs, batch records, and manufacturing documentation.
- Perform microbial fermentation and mammalian cell culture, including bacterial fermentation and single-use mammalian systems (up to 1000L).
- Operate upstream and downstream processing equipment, including continuous flow centrifuges, depth filtration, chromatography (AKTA), and HPLC systems.
- Ensure compliance with GMP, QA/QC policies, and regulatory requirements.
- Support deviation and CAPA resolution in collaboration with quality teams.
- Assist in MSAT/PD during development and scale-up activities.
- Maintain and ensure proper calibration and preventative maintenance of equipment.
- Enforce safety policies and ensure compliance within the team.
Required Experience
- Associate’s, BS, or MS degree in a Scientific or Engineering discipline.
- 4+ years (AS/BS) or 3+ years (MS) of experience in biomanufacturing.
- Experience in microbial systems and cGMP environments is essential.
- Strong understanding of Quality Management Systems and GMP principles.
- Familiarity with upstream and downstream processing in a biomanufacturing setting.
Sounds like a fit? Apply today
Please note, you will only be considered if you have the required experience listed.
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