GMP Manufacturing Associate

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

GENERAL DESCRIPTION

GMP Gene Manufacturing Associate I/II will require a professional who thrives in a dynamic team environment, brings meticulous attention to detail in the quality of their work and is proactive in implementing improvements. This position will perform a broad range of tasks in the cGMP manufacturing of clinical and commercial adenovector products. Prior experience in GMP manufacturing and operation of GMP process equipment are required.

DUTIES AND RESPONSIBILITIES

• Perform manufacturing for clinical and commercial materials in GMP setting, including, but not limited to:
• Assembling raw materials
• Execute Master Batch Records (MBR) under current Good Manufacturing Practices (cGMPs.)
• Following and assisting in the development of specific standard operating procedures (SOP), MBRs, deviations and summary reports for manufacturing
• Support initiation and closure of deviations
• Support routine cleaning and changeover procedures for clean room suites and equipment
• Participating in and facilitating technology transfer
• Work in a team based, cross-functional environment to complete production tasks.
• Adhere to all safety and regulatory requirements while performing job functions.
• This position requires occasional weekend and shift work.
• Other duties as assigned.

EDUCATION AND EXPERIENCE

• Bachelor's degree or master degree in biology, biomedical science or life science
• Minimum of one to three (1 - 3 for Associate 1, 3+ for Associate 2) years in a GMP environment required
• Aseptic technique experience is required.
• Knowledge in principles and practices of current Good Manufacturing Practices (cGMPs)
• Prior cell culture and/or purification experience in a GMP facility is preferred.

DESIRED KEY COMPETENCIES

• Comfortable in a fast-paced company environment and able to adjust workload based upon changing priorities.
• Self-motivated and willing to accept temporary responsibilities outside of initial job description and perform other responsibilities to support the needs of the department, as assigned.
• Positive interpersonal skills.
• Outstanding knowledge, and ability to apply scientific principles utilized to solve operational, as well as routine production tasks
• Ability to troubleshoot unit operations.
• Self-organizer, meticulous hands-on habits, keen attention to detail.
• Ability to manage multiple and varied tasks and prioritize workload
• Prior Tangential Flow Filtration (TFF) experience is preferred.

EOE MFDV