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 an Associate Vice President, Quality Control with the responsibility to support clinical and commercial manufacturing of a range of AAV and LVV gene therapy products.

• Overall responsibility for leading the strategic planning and technical operations of the Quality Control Department to ensure that business needs are met.
• Work with complex issues that require broad-based sustainable solutions involving other functions.
• Represent QC on the cross-functional meetings for AAV and LVV Platforms to ensure that common company objectives are met.
• Partner and align with Analytical Development/CMC/Pharmaceutical Development 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.
• Oversee critical investigations (e.g., failure/CAPA) to ensure that these result in thorough root cause analysis & implementation of effective preventive actions.
• Ensure method validations & transfers meet regulatory expectations & requirements.
• Ensure accuracy & scientific soundness of QC laboratory data.
• Ensure GMP compliance with laboratory operations and contribute to the compliance of site.
• Identify and monitor key performance metrics to optimize quality and productivity of the laboratory.
• Ensures quality control systems and equipment are compliant with all applicable regulatory guidelines and data integrity principles are adhered to, to provide confidence in the data generated.
• Tracks and trends cGMP data including the evaluation and approval of data received from external contract laboratories. Compiles and reports data with appropriate interpretations for applicable management reviews, Annual Product Reviews, and all other required assessments.
• Ensures continuous improvement across the Quality Control department.
• Maintain awareness of competitors, markets, best practices, and new industry standards and development
• Play key role in communication with external CTOs and CDMOs regarding QC testing.
• 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)
• Oversee daily operations of Quality Control organization; lead, guide, and coach a team of directors, managers, scientists, and ensure a healthy and engaged working environment.
• Identify needs and opportunities for overall strategic changes in the culture and organization.
• Manage areas of accountability via subordinate management by setting direction, following up to ensure progress and goal attainment, and to providing feedback and coaching. A high level of innovation and collaboration is expected to continuously improve QC processes and achieve improved quality.
• Set financial goals, prepare, and allocate resources, identify ways to increase revenue and decrease costs within their area of responsibility. Assist with annual budget both CAPEX and Operation levels.
• Coordinates with Quality Assurance to ensure contract laboratory service providers are suitably qualified to conduct the services contracted to them.
• Coordinates with Quality Assurance to ensure Quality Agreements are complete, approved and updated at appropriate intervals.

Education/Experience and Skills Requirements:
• PhD. in Molecular Biology, Cell Biology, Immunology, or related field with 15 years of experience in GMP/QC environment or equivalent experience in the biotechnology industry; M.S. with 15 years of experience GMP/QC environment or BS with 18 years of experience GMP/QC environment.
• Minimum of ten (10) years of leadership experience required.
• Experience with Gene/Cell therapy products (CART-Therapies) for clinical and commercial.2
• Experience with method validation and/or method transfer preferred.
• Working knowledge of GMPs & compendia requirements (USP/EP/JP) required.
• Experience interacting with regulatory health authorities at pre- and post-approval inspection.
• Experience supporting all phases of a program’s lifecycle (pre-IND through commercial lifecycle management).
• Experience authoring CMC sections of regulatory submissions.
• Strong abilities in scientific analysis and writing.

Desired Competencies:
• 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.
• Manage 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.