GMP Manufacturing Associate

Precigen, Inc; Germantown (MD); On-site; USD 70,000 - 85,000; Full time

Job summary

Precigen, Inc. in Germantown, MD is seeking a GMP Manufacturing Associate I/II to join a dynamic team focused on clinical and commercial adenovector product manufacturing. The role requires GMP experience, attention to detail, and proactive process improvement.

The position involves assembling materials, executing Master Batch Records, and supporting deviations, SOPs, and technology transfer in a fast-paced cGMP environment. Weekend/shift work may be required.

Qualifications

• Bachelor’s or Master’s degree in biology, biomedical science or life sciences is required.
• Minimum 1–3 years in a GMP environment for Associate 1, 3+ years for Associate 2.
• Aseptic technique experience is required.
• Knowledge of current Good Manufacturing Practices (cGMPs) is required.
• Prior cell culture and/or purification experience in GMP facility is preferred.

Responsibilities

• Perform manufacturing in GMP setting for clinical and commercial materials.
• Assemble raw materials and execute Master Batch Records (MBR).
• Follow SOPs, MBRs, deviations and prepare summary reports.
• Support deviations initiation and closure; assist in changeover procedures.
• Participate in technology transfer and work in cross-functional teams.
• Adhere to safety and regulatory requirements; occasional weekend/shift work.

Skills

Aseptic technique

cGMP knowledge

Team collaboration

Attention to detail

Education

Bachelor’s or Master’s in biology or life sciences

Tools

GMP equipment operation

MBR documentation

Job description

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GMP Manufacturing Associate

Full-time Regular Associate - STAFF Germantown, MD, US

Salary Range: $70,000.00 To $85,000.00 Annually

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.