Quality Control Manager, LVV

Cranbury, NJ /
Quality – Quality Control /
Full Time
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.

Be an architect of world-class Quality! 
As the regulatory environment for cell and gene therapy continues to evolve, patients are counting on developers’ culture and quality systems to deliver safe and effective products. The Rocket Quality team is a pioneer in this territory, applying efficient, effective, and compliant approaches to support a growing pipeline of five active clinical programs using both AAV and LV platforms. In a new, state-of-the-art R&D and Manufacturing facility, the Quality organization works to develop and validate the latest analytic technologies while building and continually improving quality systems that serve a robust pipeline of curative gene and cell therapies.

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, Manager LVV with the responsibility to support clinical manufacturing of a range of LVV Gene Therapy products. 

Responsibilities:

    • Perform method optimization/validation and transfer of analytical methods that include but not limited to: Cell-based assays and  Immunoassays
    • Experience required in PCR and Flow cytometry.
    • Support QC testing of LVV In-process and final product.
    • Follow up the ongoing external testing at CTOs and CDMOs.
    • Support LVV Stability Programs as needed.
    • Characterize and qualify reference standard and control materials.
    • Handle cell line expansion, characterization, banking and cryopreservation.
    • Author and review technical documents (protocols, reports, SOPs, test methods, memos and Impact Assessment).
    • 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.
    • Work with CMC and regulatory to provide Analytical information.
    • Train and assist Junior QC associates in their functions.

Requirements:

    • PhD in Molecular Biology  or Cell Biology with 2+ years of experience; M.S.  in Biology, Molecular biology, Immunology with 8+ years of industry experience or BS in Biology, Immunology with 10+ 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 and make decision.
    • Thorough knowledge of cGMPs (CFR/ICH/EU) and applicable international regulations and guidelines as they apply to drug manufacturing and aseptic processing.
    • 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.
    • 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.
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.

Full COVID-19 vaccination is required for employment at Rocket Pharmaceuticals.