Senior Director, Quality Control
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.
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 for a Sr Director, Quality Control with the responsibility to support clinical and commercial manufacturing of a range of AAV and LVV gene therapy products.
Responsibilities:
- Overall responsibility for the strategic planning and technical operations of the Quality Control Department to ensure that business needs are met.
- Full oversight of bioanalytical assays, cell-based assays, compendial assays, method validation, raw materials, stability program management, environmental monitoring, and microbiology.
- Represent QC on the cross-functional meetings for AAV and LVV Platforms to ensure that common company objectives are met.
- Provide strategic leadership to further strengthen both AAV and LVV platforms with a highly efficient QC organization.
- Establish proper communication channels to manage, mentor direct reports to higher levels of management capability and provide strategic leadership to further strengthen the platform with a highly functional QC AAV team.
- Play key role in communication with external CTOs and CDMOs regarding QC testing.
- Provide technical guidance for validation of analytical methods as well as ensuring adequate management of all Critical Reagents, Reference Standard, Analytical Cell Banks and Reference Standard/Controls materials used in the laboratory.
- Identify and monitor key performance metrics to optimize quality and productivity of the laboratory.
- Ensure that QC decisions are aligned with Rocket’s Quality Management System and regulatory requirements.
- Ensure that adequate Laboratory Controls are in place, and Procedures and Instructions are very comprehensive to facilitate flawless execution in the QC laboratories.
- Ensure continuous improvement of departmental SOPs to stay up-to-date with regulatory and compliance guidelines in conjunction with being fit for purpose operationally and commercially
- Evaluate and track the performance of the assays. Implement Quality management system to ensure risks are adequately controlled in accordance with requirements.
- Ensure all activities are performed in accordance with GMP in the laboratories, and monitor the compliance through robust internal audit program.
- Partner and align with AD/CMC and Program management to implement strategies and drive organizational success
- Plan strategically/proactively with management to ensure that resources are allocated adequately to meet each program’s needs
- Review technical documents (protocols, reports, SOPs, test methods, Risks and Impact Assessment)
- Ensure that QC decisions are aligned with governance from Quality Management System and regulatory requirements
- Coordinate management structure of the laboratory to build Analytical datasets (release and stability, analytical validation) for Starting materials, DS and DP so they are readily available to support CMC and all Regulatory filings (IND/BLA)
- Identify gaps and assist with annual budget both CAPEX and Operation levels
Responsibilities:
- PhD. in Molecular Biology, Cell Biology, Immunology or related field with 12 years of experience in QC or equivalent experience in the biotechnology industry; M.S. with 15 years of experience or BS with 18 years of experience
- Experience with Gene/Cell therapy products (CART-Therapies) for clinical and commercial
- Strong abilities in scientific analysis and writing
- Strong analytical skills in different techniques to troubleshoot and investigate issues from the testing
- Strategic thinker and demonstrate problem solving skills
- Progressive 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
- Handle issues appropriately and with a sense of urgency
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.
