JOB 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.
We are seeking a highly motivated individual to join us as a Quality Control Analyst II/III. (level determined by candidate experience) This position provides Quality Control Testing of clinical products, in-process and final product testing in addition to qualification of QC instrumentation.
This is an onsite role based in our Germantown, MD facility.

GENERAL DESCRIPTION:

• QC Analyst is responsible for performing lot release and stability testing following approved SOP’s in a cGMP compliant laboratory, and training junior staff. They will participate in technology transfer and validation activities, including protocol and report writing. Additionally, they will maintain and operate GMP equipment and perform general laboratory duties including ordering/receiving QC materials.

EDUCATION AND EXPERIENCE:

• Bachelor’s Degree in biological science or related field.
• Minimum of five (5) years’ experience working in a regulated QC laboratory for biological test samples, with demonstrated responsibility progression.
• Experience with analytical methods specific to gene therapy products including (but not limited to) PCR/RT-qPCR, ELISA, Spectrophotometry, Dynamic Light Scatter and HPLC.
• Demonstrated experience in the development of SOPs.
• Knowledge in principles and practices of current Good Manufacturing Practices (cGMPs.)
• Experience with methods and systems used in a biological QC laboratory.

• Perform GMP release and stability testing in Quality Control including but not limited to: Cell-based potency assays, PCR/RT-qPCR, ELISA, Spectrophotometry, and Dynamic Light Scatter for biological samples.
• Perform HPLC for biological samples and Troubleshoot Agilent HPLC equipment and Empower software.
• Train junior Analysts on test methods.
• Participate in technology transfer and validation activities including protocol and report writing.
• Complete documentation, including testing records and equipment logs, following Good Documentation Practices.
• Write, revise and review QC SOP’s.
• Conduct peer review of test data and equipment logs.
• Maintain and operate QC laboratory equipment in a cGMP-compliant manner.
• Order, receive and manage inventory for QC materials.
• Apply critical thought to solving problems of complex scope.
• Prepare investigation reports, including those related to OOS, invalid assays and deviations.