Quality Control Analyst III

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.

In support of these efforts, we are seeking a hard-working Quality Control Analyst III who is serious about their discipline and wants to be a key player in a high-performing team. This position will help guide the Quality Control team while also working hands-on performing and training on analytical testing for lot release and stability samples following approved SOP’s in a GMP compliant laboratory. The QC Analyst III will oversee laboratory maintenance and ordering. Responsibilities also include analytical method development and qualification, ensuring that samples are collected, tested, and reviewed according to quality requirements and that results reported are valid, accurate, and documented per applicable regulatory and corporate requirements.

DUTIES AND RESPONSIBILITIES:

  • Perform GMP release and stability testing in Quality Control including but not limited to: HPLC for biological samples, Spectrophotometry, pH, Conductivity, Dynamic Light Scattering (DLS) and PCR/RT-PCR.
  • Supervision of other Analysts in the completion of HPLC testing.
  • Maintain and troubleshoot HPLC instrumentation.
  • Participate in analytical method development, qualification, validation and technology transfer.
  • Manage and operate QC laboratory equipment in a cGMP-compliant manner
  • Oversee ordering and receiving of QC materials.
  • Write and revise QC SOP’s.
  • Apply critical thought to solving problems of complex scope.
  • Prepare investigation reports, including those related to OOS, invalid assays and deviations.

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 or assay development, with demonstrated responsibility progression.
  • Demonstrated experience in conducting HPLC assays.
  • Demonstrated experience using Agilent HPLC systems and Empower software.
  • Experience with analytical methods specific to cellular and gene therapy products including (but not limited to) Spectrophotometry, DLS, and PCR/qPCR preferred.
  • 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.

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.

#LI-ONSITE #LI-AZ1

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