Manager, Quality Control- Stability

Rocket Pharmaceuticals - Cranbury, NJ

Full-time - Mid Level

Cranbury, NJ

Professional, Scientific, and Technical Services

About the position

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.

Responsibilities

• Coordinate the Stability Program across all programs and platforms of development, clinical, and commercial drug products at Rocket.
• Ensure compliance in stability testing, study protocols, Quality Agreements, data analysis, and regulatory submissions/commitments.
• Collaborate with cross-functional teams to maintain product quality and efficiency while monitoring project timelines and identifying opportunities for improvement in the stability program.
• Facilitate and execute stability study protocols and design including calculation and execution of stability study set downs and pulls independently.
• Create, revise, and approve SOPs, and reports in accordance with current GMP, FDA, EU, Global, and ICH guidelines and regulations.
• Assist with the summarization of stability data and interim reports.
• Serve as the primary point of contact for stability-related inquiries and issues.
• Ensure all records adhere to cGMP/GDP expectations.
• Maintain the Stability Master planner across all programs.
• Follow up all ongoing external stability studies at Contract Testing Laboratories and Contract Development, and Contract Development Manufacturing Organizations.
• Maintain quality metrics for stability testing adherence.
• Support investigations related to stability data by performing root cause analyses and develop corrective actions.
• Author, review, and/or approve data and trending reports.
• Identify areas for improvement and drive projects to implement solutions.
• Effectively communicate with internal and external stakeholders.
• Provide strong teamwork in establishing a quality culture and shared accountability.
• Monitor, react, track and publish clinical and commercial stability program KPIs.
• Ensure accurate and timely documentation and reporting of stability data to Quality Assurance.
• Ensure all stability studies comply with GMP, ICH guidelines, and other relevant regulatory requirements.
• Conduct regular audits of stability studies and processes to maintain high-quality standards.
• Implement corrective and preventive actions (CAPAs) as needed to address any deviations or non-conformances.
• Manage QMS records for QC Stability which includes deviations, change controls, CAPA, and other applicable stability-related investigations and events.

Requirements

• M.S. in Biology, Molecular biology, Immunology with 6+ years of industry experience or BS in Biology, Immunology with 8+ years of relevant experience in QC environment managing a stability program or equivalent experience in biotechnology industry.
• Experience in the administration of a stability program for Gene/Cell therapy products for clinical, commercial products, including viral vector and other critical materials.
• Knowledge of cGMPs CFR/ICH/EU and applicable international regulations and guidelines as they apply to drug manufacturing, aseptic processing, quality control and stability.
• Experience implementing corrective and preventive actions (CAPAs) as needed to address any deviations or non-conformances.
• Experience creating, revising, and approving SOPs, and reports in accordance with current GMP, FDA, EU, Global, and ICH guidelines and regulations.
• Experience with cell and gene therapy assays including UV-spectroscopy, microscopy, and flow cytometry, chromatography, dissolution, Karl Fisher, SEC-HPLC, RP HPLC, IEX, SDS-Page, cIEF, AUC, and compendial assays as well as ELISA (Plate base assay), potency assay (cell-based assays), and PCR.
• Effective communication skills, both verbal and written.
• Ability to prioritize objectives from multiple projects, adhere to scheduled timelines while maintaining flexibility and attention to detail; work independently and make decisions; interpret analytical data and investigate issues from the testing; to think critically and demonstrate problem-solving skills; interact, cooperate and motivate across departments and functions.

Nice-to-haves

• Demonstrate problem-solving skills.
• Possesses a positive, can-do attitude and creatively solves problems.
• Handle issues appropriately and with a sense of urgency.
• Project management skills to support a multi-project environment in small biotech.
• Ability to interact, cooperate across departments and functions.
• Ability to work efficiently and adapt quickly to new challenges and priorities.
• Proactive attitude with a strong sense of ownership, accountability, and commitment to achieving the organization's goals.

Benefits

• Competitive compensation package featuring a generous 401K match and stock options.
• Excellent health benefits.