QC Analyst I/II, Environmental Monitoring

2 months ago

Germantown, United States Precigen, Inc Full time
Job DescriptionJob Description

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 novel manufacturing processes to deliver UltraCAR-T® and AdenoVerse™ immunotherapies to patients. We have multiple products being evaluated in the clinic using our innovative manufacturing approach to cell and gene therapies.

Precigen, Inc. is seeking a hard-working QC Analyst I/II, Environmental Monitoring who is serious about their discipline and wants to be a key player in a high-performing team. This position will require performing environmental monitoring sampling, sample incubation, as well as data analyzing and reporting according to quality requirements to support GMP manufacturing. Secondary responsibilities include GMP lot release testing.

DUTIES AND RESPONSIBILITIES:

  • Perform environmental monitoring duties including sampling of viable surfaces, viable air and non-viable particulates in a GMP Manufacturing Facility.
  • Incubation and culture of viable EM samples
  • Perform GMP personnel gowning certifications.
  • Report results from environmental monitoring and personnel samples and ship for ID testing when applicable.
  • Report and investigate environmental monitoring excursions.
  • Track and trend EM data.
  • Write and revise QC SOP’s related to environmental monitoring equipment and procedures.
  • Perform QC testing of raw materials and/or schedule testing through contract testing laboratories.
  • Perform QC lot release testing including but not limited to: Endotoxin, Gram Stain, Bioburden.
  • Maintain and operate QC laboratory equipment in a cGMP-compliant manner.
  • General maintenance of the laboratory including ordering and receiving QC materials.

EDUCATION AND EXPERIENCE:

  • Bachelor’s Degree in biological science
  • Minimum of 2-years environmental monitoring experience in a GMP environment.
  • Knowledge in principles and practices of current Good Manufacturing Practices (cGMPs).
  • Experience with methods and systems used in a biological QC laboratory.

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.
  • Self-organizer, meticulous hands-on habits, keen attention to detail.
  • Ability to manage multiple and varied tasks, and prioritize workload.
  • 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.
  • Responsive, can-do attitude.
  • Deals with conflict in a direct, positive manner.
  • Ability to think and adapt to a rapidly changing environment and demands.

EOE MFDV

Precigen (Nasdaq: PGEN) 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 immuno-oncology, autoimmune disorders, and infectious diseases. We invite you to discover more at www.precigen.com.

#LI-ONSITE #LI-AZ1

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