Precigen is a dedicated discovery and clinical stage biopharmaceutical company advancing the next generation of gene and cell therapies using precision technology to target the most urgent and intractable diseases in our core therapeutic areas of immuno-oncology, autoimmune disorders, and infectious diseases.

Precigen has developed a novel manufacturing process to rapidly produce and deliver UltraCAR-T® therapies to patients. We have multiple products being evaluated in the clinic using this non-viral, rapid and innovative manufacturing approach to cell therapies.

We are seeking an experienced GMP Cell Therapy Manufacturing Associate at our Germantown, MD location to join us in our mission to serve patients with our next generation of innovative cell therapies. This position 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 manufacture of cell therapy products for use in clinical studies in our growing pipeline. Prior experience in GMP cell therapy manufacturing and operation of GMP equipment is required.

Upon hire to this position Precigen will require documentation of a COVID-19 vaccination or exemption for medical or religious reasons.

DUTIES AND RESPONSIBILITIES:

• Perform cell therapy product manufacturing for use in clinical trials in a GMP focused setting, including, but not limited to:
  • Maintain appropriate inventories of materials support manufacturing activities
  • Ensure raw materials are identified, prepared and available in time for all production runs
  • Follow detailed standard operating procedures (SOP) for manufacturing
  • Operate GMP manufacturing equipment and troubleshooting issues
  • Complete batch records, logbooks and other GMP documents using cGDP
  • Report and investigate deviations
  • Support technology transfers to and from the site
• Work in a team-based, cross-functional environment to complete production tasks.
• Adhere to all regulatory requirements while performing job functions.

EDUCATION AND EXPERIENCE:

• Bachelor's degree or Master’s degree in biology, biomedical science, or life science.
• Minimum of 2 years prior cell therapy manufacturing experience in a GMP facility.
• Knowledge in principles and practices of current Good Manufacturing Practices (cGMPs.)
• Outstanding aseptic technique in GMP cleanroom environment.
• Demonstrated ability to think critically with proven troubleshooting and analytical skills.
• Experience with automated processing equipment in GMP environment.

DESIRED KEY COMPETENCIES:

• Comfortable in a fast-paced company environment and able to adjust workload based upon manufacturing schedule.
• Comfortable working fully gowned within a cleanroom environment.
• Self-organizer, meticulous hands-on habits, keen attention to detail.
• Self-motivated and willing to accept temporary responsibilities outside of initial job description.
• Ability to work off-shift and extra hours if required.
• Perform other responsibilities to support the needs of the department, as assigned.
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
• Proficient in MS-Word and MS-Excel.
• Strong quantitative and analytical skills.
• Ability to understand and execute on the company’s mission and values.
• Maintain a high degree of ethical standard and trustworthiness.
• Exhibits and open mindset when approaching challenges and conflict.
• Ability to think and adapt to a rapidly changing environment and demands.

EOE MFDV