Quality Control Scientist

Position Summary

Quality Control Scientist

Rocket Pharma is a company bringing hope and relief to patients with undertreated rare diseases through the development and commercialization of curative first-in-class gene therapies. We are seeking a Quality Control Scientist with the responsibility to support clinical manufacturing of a range of Gene Therapy products. Technical proficiency in analytical methodology for drug substances and drug products is required for gene based products. 

Primary Responsibilities:

  • Experience with mammalian and progenitor cell culture maintenance and passage
  • Perform assays in support of method optimization/validation and method transfer for gene therapy products
  • Support analytical and process development activities
  • Conduct GMP study projects
  • Experience in GxP environment
  • Hands-on experience, immunoassays, q-PCR and/or ddPCR
  • Hands-on experience with binding assays (ELISA, Flow Cytometry) and in cell-based functional assays
  • Support daily QC operations by maintaining cell culture, controls and reference materials
  • Perform routine testing of samples for release and stability
  • Documents test execution according to cGMP, maintains up to date QC records, logbooks and notebooks
  • Review protocols, data summaries, reports for stability studies and validation
  • General biological lab experience

Education/Experience and Skills Requirements:

  • MS or BS in Biology, molecular biology, virology, Life Sciences or equivalent
  • MS/BS + 3 years of relevant experience in QC or equivalent experience in biotechnology industry
  • Preferred experience with Gene/Cell therapy products for clinical and commercial
  • Ability to work independently with excellent problem solving skills
  • Expertise in method validation
  • Thorough knowledge of cGMPs (CFR/ICH/EU) and applicable international regulations and guidelines as they apply to drug manufacturing and aseptic processing

Desired Competencies:

  • Hands-on experience with AAV or other viral vectors for gene therapy is highly preferred
  • Strong analytical skills to troubleshoot and investigate issues from the testing
  • Strong leadership and project management skills to support a multi-project environment in small biotech or large pharma
  • Ability to interact, cooperate and motivate across departments and functions
  • Effectively works in a fast-paced pharmaceutical environment with prior start-up experience preferred
  • Handle issues appropriately and with a sense of urgency
  • Possesses a positive, can-do attitude and creatively solves problems

Interested in joining our team?

Contact us today!

Resumes with cover letters may be submitted to careers@rocketpharma.com