Quality Control Analyst II

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, Cell Based Assays with an emphasis on cell-based test methods. This position provides Quality Control Testing of clinical products responsible for raw materials, in-process and final product testing in addition to qualification of QC instrumentation.

This is an onsite role based in our Germantown, MD facility.

DUTIES AND RESPONSIBILITIES:

• Perform the following test methods: cell based and PCR based.
• Maintain cell cultures.
• Complete routine records of test results data and related documents associated with testing.
• Maintain lab equipment and perform lab equipment cleaning.
• Order and maintains laboratory consumables.
• Participate in method transfers from development into quality control.
• Participate in conducting lab investigations, writing deviations and implementing CAPAs.
• Develop, revise and review SOPs.
• Responsibility may also include performing GMP lot release and stability testing for gene therapy products.

EDUCATION AND EXPERIENCE :

• Bachelor’s Degree in biological science or related field.
• Minimum of three (3) years’ experience working in a regulated environment Demonstrated experience working with, or development, of SOPs. Knowledge in principles and practices of current Good Manufacturing Practices (cGMPs.)
• Proficiency in aseptic technique, cell culture and the use of automated cell counting.
• Experience with cell culture required.
• 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 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 .

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