Associate Director, Quality Control – Method Validation

Cranbury, NJ /
Quality – Quality Control /
Full Time
/ On-site
Work at ROCKET PHARMA and help cure rare diseases!

Rocket Pharma is a fully integrated, clinical-stage company advancing gene therapies with curative potential for multiple rare childhood diseases. Rocket places enormous value on people and considers team member progress and well-being to be as important as the progress of its pipeline. We are looking for hands-on team players who enjoy collaborating with colleagues.  We share a passion for seeking gene therapy cures for devastating diseases and making a difference for patients. This is an opportunity to become an integral part of a small, highly productive team and to help grow an entrepreneurial, scientifically driven organization that is increasingly recognized as a leading biotechnology innovator. In addition to a competitive compensation package featuring a generous 401K match and stock options, the position includes excellent health benefits.

We are seeking for an Associate Director, Quality Control – Method Validation with the responsibility to support clinical and commercial manufacturing of a range of AAV and LVV gene therapy products. 


    • Validate Analytical Methods for both platforms( AAV and LVV) from Rocket Analytical & Development and and/or external laboratories to Rocket Quality Control labs using various Analytical techniques which include but not limited to Flow cytometry, q-PCR, ddPCR, ELISAs and Chromatographic techniques
    • Evaluate new technologies for method optimization
    • Partner and align with AD/CMC and Program management to meet the objectives of each program plan 
    • Plan strategically with other QC Managers to ensure that resources are allocated adequately to meet the program’s needs
    • Author QC version of Analytical Methods post transfer
    • Author and review technical documents (protocols, reports, SOPs,  Risks and Impact Assessment)
    • Ensure that QC decisions are aligned with Rocket’s Quality Management System and regulatory requirements including but not limited to the following: 
    • Qualification of Analytical Cell Banks
    • Characterization and qualification of Reference standards and Control Materials used for all analytical testing of DS LVV
    • Qualification of Critical Reagents
    • QC data review of all qualification/validation activities 
    • Work with cross functional peers to meet company’s deadlines
    • Author in a timely manner the validation reports so they are readily available to support all filings 
    • Prepare source documents and compile data sets  as required for Regulatory and CMC to support IND/BLA 
    • Identify gaps and assist with annual budget both CAPEX and Operation levels


    • PhD. in Molecular Biology, Cell Biology, Immunology or related field with 8 years of experience in QC or equivalent experience in the biotechnology industry; M.S. with 10 years of experience or BS with 12 years of experience 
    • Preferred experience with Gene/Cell therapy products (CART-Therapies) for clinical and commercial
    • Strong abilities in scientific analysis and writing
    • Strong analytical skills to troubleshoot and investigate issues from the testing
    • 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
    • Ability to work 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
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.