Manufacturing Technician

Manufacturing Associate I/II — Downstream

Location: San Diego, CA

Schedule: Full-Time, Onsite

Pay Rate: $24/hr - $37/hr

Position Summary

The Manufacturing Associate I/II, Downstream will support GMP manufacturing operations with a primary focus on downstream processing activities, including purification and related sub-processes, in an onsite biopharmaceutical production environment. This role is best suited for an entry- to mid-level candidate with hands-on chromatography and AKTA experience, UFDF/TFF knowledge, strong GMP documentation habits, and the ability to work effectively in a fast-paced, team-oriented setting.

Key Responsibilities

• Perform downstream manufacturing operations in accordance with approved SOPs, batch records, and GMP documentation requirements.
• Execute purification-related processing steps and support routine manufacturing activities in assigned GMP areas.
• Set up, operate, maintain, and clean downstream bioprocessing equipment, including chromatography systems, UF/DF systems, filtration skids, and mixers.
• Perform hands-on chromatography work, including AKTA operation.
• Support UFDF or TFF processes; manual operation experience is a plus.
• Complete batch records, equipment logs, and other GMP documentation accurately and in a timely manner following Good Documentation Practices.
• Assist with SOP and batch record revisions as needed.
• Perform basic troubleshooting of downstream process equipment and escalate issues appropriately.
• Support cleaning, sterilization, setup, and readiness activities in manufacturing areas.
• Collaborate with team members to meet production goals and support process improvements.

Qualifications

• Associate’s or Bachelor’s degree in Biology, Biochemistry, Biotechnology, Chemical Engineering, or a related scientific discipline preferred.
• Entry- to mid-level experience in pharmaceutical or biotech manufacturing preferred.
• Strong downstream processing experience required.
• Hands-on experience with chromatography and AKTA systems required.
• Experience with UFDF or TFF required; manual operation is strongly preferred.
• Understanding of the science behind downstream processing, not just task execution.
• Working knowledge of cGMPs, SOPs, batch records, and GMP documentation practices required.
• Experience with protein chromatography, TFF, depth filtration, viral filtration, bulk drug substance formulation, final filtration, buffer preparation, and aseptic sampling is highly desirable.
• Experience with UNICORN or similar control software is a plus.
• Strong communication skills, attention to detail, and the ability to work cross-functionally are important for success in this role.

Work Environment / Schedule

• Fully onsite, 5 days per week
• Flexible schedule based on production needs, including options such as 8:00 AM - 4:00 PM or 9:00 AM - 5:00 PM
• Earlier or later hours may be needed depending on manufacturing demands
• Some overtime expected, with occasional weekend work and advance notice
• Approximately 70% floor operations and 30% documentation