We are seeking a Manager, QC Materials with the responsibility to support clinical manufacturing of a range of AAV and LVV Gene Therapy products.

• Perform method optimization/validation and transfer of analytical methods that include but not limited to: Cell-based assays, Immunoassays, Biochemical assays (Capillary Electrophoresis, HPLC/UPLC)
• Conduct Risk Assessment (RA) for the development of the 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
• Experience with droplet digital PCR (ddPCR), qPCR, Flow cytometry
• Develop, review and execute stability protocols for critical raw materials
• Maintain the Stability Master planner for raw materials stability
• Follow up the ongoing external stability studies for raw materials at CTOs and CDMOs if applicable.
• Support QC testing of raw materials
• Author and review technical documents (protocols, reports, SOPs, test methods, memos and Impact Assessment) relevant to Raw Materials
• Work with cross functional peers to meet company’s deadlines
• Perform QC data review, generate CoAs and all related QC documents for QC release of products in accordance to Rocket’s procedure
• Assure that all required QC records (testing, methods, protocols, reports and raw data) are generated and approved
• Train and assist Junior QC associates in their functions

• MS in Biology, Molecular biology, Immunology with 6+ years of industry experience or BS in Biology, Immunology with 8+ years of relevant experience in QC or equivalent experience in the biotechnology industry.
• Preferred experience with Gene/Cell therapy products for clinical and commercial.
• Ability to work independently and make decision.
• Expertise in method validation.
• Experience with mammalian cell culture.
• Thorough knowledge of cGMPs (CFR/ICH/EU) and applicable international regulations and guidelines as they apply to drug manufacturing and aseptic processing.
• Expertise in analytical characterization of viral vectors.
• Strong analytical skills to troubleshoot and investigate issues from the testing.
• Expertise in multi color flow cytometry technology.
• Ability to think critically and demonstrate problem solving skills.
• Leadership experience and project management skills to support a multi-project environment in small biotech.
• 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.

The expected salary range for this position is $118,000 to $154,000.

At Rocket, our compensation philosophy and ranges are built upon data and insights collected from validated world-class providers. We are committed to compensating employees equitably based on several factors, including responsibilities and level of the position, depth and types of the employee’s experience, location of the position and availability of similar talent in a competitive market.

For U.S.-based candidates, this is an at-will position, and Rocket reserves the right to adjust the range at hire or during the year due to market shifts.

In addition to base salary, Rocket offers a competitive total rewards package that may include bonuses (short-term incentives), medical, dental, and vision insurance, life insurance, 401(k) with company match and generous vesting, paid vacation and holidays, global shutdown days between Christmas and New Year’s, and a variety of wellness resources and employee support programs. Also, certain positions are eligible for added forms of compensation, such equity awards (long-term incentives).

A diverse workforce fosters innovation and strengthens Rocket’s business. We ensure equal opportunity without discrimination or harassment in the workplace on the basis of gender, race, color, religion, national origin, age, physical or mental disability, pregnancy, citizenship, status as a protected veteran, marital status, sexual orientation, gender identity and expression, genetic information, or any other characteristic protected by applicable local, state, and federal laws.