Manager, Quality Control - Raw Materials

Rocket Pharma
Cranbury, NJ
Category Research
Job Description
ROCKET PHARMA is seeking a Manager of Quality Control for their raw materials program, supporting clinical manufacturing of AAV and LVV Gene Therapy products. The role involves method optimization, risk assessment, specification development, quality inspection, and qualification/validation of assays. The company values collaboration, scientific rigor, and employee wellbeing, aiming to be a leading biotechnology innovator.

Requirements

  • Perform method optimization/validation and transfer of analytical methods.
  • Conduct Risk Assessment (RA) for the development of Raw Materials program.
  • Review and Develop specifications for Raw materials.
  • Manage the Raw materials program within QC.
  • Manage Raw materials inspection.
  • Manage the qualification/validation of assays for raw materials testing.
  • Support QC testing of raw materials.
  • Author and review technical documents.
  • Work with cross-functional peers to meet deadlines.
  • Perform QC data review, generate CoAs and all related QC documents.
  • Train and assist Junior QC associates.
  • Hold issues appropriately and with a sense of urgency.
  • Handle issues appropriately and with a sense of urgency.
  • Possess a positive, can-do attitude.

Benefits

  • Competitive compensation package
  • 401k match
  • Stock options
  • Medical, dental, and vision insurance
  • Life insurance
  • Paid vacation and holidays
  • Wellness resources
  • Employee support programs
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