GMP Biotech Manufacturing Associate II

Abzena Ltd; San Diego (CA); On-site; USD 70,000 - 90,000; Full time

Job summary

Abzena Ltd in San Diego, CA, seeks a GMP Biologics Manufacturing Associate to execute daily tasks in strict compliance with batch records, SOPs, and GMP. You will own the production process, collaborate with QA, MS&T, Facilities, and other departments to support compliant manufacturing and operational success.

This role involves shift progression, aseptic processing in cleanrooms, and performing downstream steps. A minimum of 2 years’ GMP biotech experience and a technical degree are required.

Qualifications

• Minimum of 2 years in a GMP pharmaceutical/biotech environment with a technical degree or equivalent.
• Knowledge of cGMPs and how they apply to responsibilities.
• Experience with aseptic handling, including BSC operations to maintain sterile systems.
• Knowledge of purification using column chromatography.
• Experience using single-use technologies (tube welding, tube sealing, disposable systems).
• Ability to perform basic arithmetic calculations.

Responsibilities

• Operate under cGMP manufacturing conditions.
• Ensure training compliance prior to GMP execution.
• Adhere to gowning procedures for Class 10,000 and Class 100,000 cleanrooms.
• Perform aseptic operations in a biosafety cabinet and maintain asepsis.
• Ensure right‑the‑first‑time performance of all process steps.
• Carry out production activities including depth filtration, chromatography, viral inactivation, tangential flow filtration, and sterile fills.
• EscALate process issues as they arise and maintain proper batch readiness.
• Inventory manufacturing lab supplies and ensure proper stocking.

Skills

GMP manufacturing

Aseptic handling

Team collaboration

Quality compliance

Education

Technical degree or equivalent

Tools

Column chromatography

Single-use systems

BSC operations

Downstream processing equipment

Job description

Abzena Ltd in San Diego, CA, seeks a GMP Biologics Manufacturing Associate to execute daily tasks in strict compliance with batch records, SOPs, and GMP. You will own the production process, collaborate with QA, MS&T, Facilities, and other departments to support compliant manufacturing and operational success.

This role involves shift progression, aseptic processing in cleanrooms, and performing downstream steps. A minimum of 2 years’ GMP biotech experience and a technical degree are required.