Manager, Quality Control- Stability

Overview

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.

Position Summary

Rocket Pharmaceuticals 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 an Manager, Quality Control Stability with the responsibility to support clinical and commercial manufacturing of a range of AAV and LVV gene therapy products. Strong technical expertise in standard CGT analytical methodologies and strong communication and collaboration skills are necessary to succeed in this role.

Responsibilities

• Coordinate the Stability Program across all programs and platforms of development, clinical, and commercial drug products at Rocket including Starting Materials, Drug Substances, Drug Product, Critical Reagents, Reference Standard and Reference Materials. Also, ensures compliance in stability testing, study protocols, Quality Agreements, data analysis, and regulatory submissions/commitments.
• Collaboration with cross-functional teams to maintain product quality and efficiency while monitoring project timelines and identifying opportunities for improvement in the stability program.
• Facilitates and executes stability study protocols and design including calculation and execution of stability study set downs and pulls independently.
• Creation, revision, and approval of 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.
• Authors, reviews, and/or approve data and trending reports
• Identifies areas for improvement and drives 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.

Qualifications

• 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. Managing QMS records for QC Stability which includes deviations, change control