GMP Gene Manufacturing Specialist (Clinical & Commercial)

Precigen; Germantown (MD); On-site; USD 60,000 - 90,000; Full time

Job summary

Precigen is seeking a GMP Gene Manufacturing Associate I/II to join a dynamic team responsible for cGMP manufacturing of adenovector products. The role requires attention to detail, proactive improvements, and experience operating GMP process equipment.

The position involves assembling materials, executing MBRs, following SOPs, and supporting deviations, clean room changeovers, and technology transfer in a fast-paced environment. Weekend and shift work may be required.

Qualifications

• Bachelor's or Master's in biology or life sciences.
• 1-3 years in GMP environment (Associate I: 1-3 yrs; Associate II: 3+ yrs).
• Aseptic technique experience required.
• Knowledge of cGMPs and SOPs.

Responsibilities

• Perform GMP manufacturing for clinical and commercial materials.
• Assemble raw materials.
• Execute Master Batch Records (MBRs) under cGMPs.
• Follow SOPs, MBRs, deviations, and reports.
• Support deviations initiation/closure.
• Support cleaning and changeover in clean rooms.
• Assist in technology transfer.
• Work in cross-functional teams to complete production tasks.
• Adhere to safety and regulatory requirements.
• Occasional weekend and shift work.

Skills

GMP manufacturing

Aseptic technique

Team collaboration

Attention to detail

Education

Bachelor's degree in biology/life science

Master's degree in biology/life science

Tools

MBR execution

SOP adherence

Job description

Precigen is seeking a GMP Gene Manufacturing Associate I/II to join a dynamic team responsible for cGMP manufacturing of adenovector products. The role requires attention to detail, proactive improvements, and experience operating GMP process equipment.

The position involves assembling materials, executing MBRs, following SOPs, and supporting deviations, clean room changeovers, and technology transfer in a fast-paced environment. Weekend and shift work may be required.