Gene Therapy Quality Assurance Specialist

5 days ago


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

Precigen, Inc is a dedicated biopharmaceutical company advancing the next generation of gene and cell therapies using precision technology to target life-threatening diseases. The company has developed novel manufacturing processes to deliver UltraCAR-T and AdenoVerseTM immunotherapies to patients with various types of cancer.

We are seeking a highly motivated and organized Lab Operations Coordinator, Quality Control who will support Sample Management, Stability Management, Sample Shipping, Outside Testing Services and Raw Materials. This cross-functional role requires collaboration with different departments such as manufacturing, supply chain, facilities, and testing groups.

Duties and Responsibilities:

  • Support activities within the scope of the Lab Operations Group, including sample submission, receipt, shipment, Purchase order generation, and coordination of testing with Outside Testing Laboratories.
  • Implement Raw Material Program activities, ensure proper handling and storage of samples and materials per procedures, and support the QC sample retain program.
  • Author quality documents, such as standard operating procedures, stability assessment reports, stability protocols, submission forms, etc.

Required Skills and Qualifications:

  • BS/BA degree in a related field and 2+ years of Quality Control experience in a GMP environment.
  • Excellent attention to detail, communication, and interpersonal skills; able to work cross-functionality.
  • Able to effectively collaborate amongst individuals, open to learn and implement new processes.

The estimated salary for this position is around $65,000 - $85,000 per year, depending on qualifications and experience. As a key player in our high-performing team, you will have the opportunity to grow professionally and make a meaningful contribution to the development of innovative gene and cell therapies.



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