Rocket Pharmaceuticals
Associate Director, Quality Control- Stability
Rocket Pharmaceuticals, Cranbury, New Jersey, United States,
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 Associate Director, Quality Control 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:
Responsibility for the QC Raw Materials, and Stability programs across AAV and LVV platform and all stages of development through commercialization. Oversee stability programs to ensure timely testing, real-time trending, and generation of stability reports. Develop stability reports and summaries for inclusion in INDs, BLAs, and other regulatory submissions. Monitor, report, and escalate any trends from stability testing results to management, ensuring timely awareness and action on potential quality issues. Mentor and train team members on stability study design, execution, and data analysis techniques, fostering their professional growth and expertise in biopharmaceutical stability studies and comparability programs. Perform data review of trending for in-process testing, release, and stability and identify data trends, to ensure compliance with regulatory filings and ICH or other global health authority guidance documents. Review, approve and ensure thorough investigation of Invalid Assay(IA), out-of-specification (OOS) and out-of-trend (OOT) results, coordinating with QC teams to identify root causes and implement corrective and preventive actions (CAPAs). Manage investigations for significant deviations and quality incidents related to testing at CTL sites, ensuring thorough resolution to maintain product quality and compliance. 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. Ensure all activities are performed in accordance with GMP in Rocket laboratories and at external vendors; monitor the compliance through robust internal audit program. Ensure that all systems, laboratory controls, procedures and instructions are described adequately to enable assurance of quality of the test results generated in the QC laboratories and at external vendors. Establish proper communication channels to manage, mentor direct reports to higher levels of management capability. Partner and align with Analytical Development/Pharmaceutical Development/CMC and Program management to implement strategies and drive organizational success. Deliver results in a team-oriented setting and willing to work across scientific disciplines to drive programs through critical milestones. Plan proactively with management of other platform to ensure that resources are allocated adequately to meet each program’s needs. Write, and 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, including Plasmids, Cell Banks, Drug Substance and Drug Product 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. Qualifications:
Education/Experience and Skills Requirements: M.S. with 8 years of Quality Control experience or BS with 12 years of Quality Control experience in biotech industry and in an GMP environment. In-depth technical, regulatory understanding and experience with Gene/Cell therapy products manufacturing and testing including applicable international regulations/standards (GMP regulations, US FDA and European regulatory requirements, ICH Guidelines, and Quality System Regulations, ICH guidelines) in all phases of product development and commercialization. Including experience performing statistical analysis. Hands-on industry experience in Quality Control authoring, reviewing, and approving various release, stability of drug substance and drug product assays in GMP setting including upstream and downstream GMP Drug Substance manufacturing, and Drug product. Proven track record managing stability programs and COA processes for clinical and commercial products. Hands on experience overseeing a raw materials program. Experience writing stability reports and summaries for inclusion in INDs, BLAs, and other regulatory submissions. Experience creating, revising, and approving SOPs, and reports in accordance with current GMP, FDA, EU, Global, and ICH guidelines and regulations. Experience performing data review, including trending for in-process testing, release, and stability and identify data trends, to ensure compliance with regulatory filings and ICH or other global health authority guidance documents. Experience authoring, and approving investigations related to Invalid Assay(IA), out-of-specification (OOS) and out-of-trend (OOT) results, coordinating with QC teams to identify root causes and implement corrective and preventive actions (CAPAs). Experience managing significant deviations and quality events at Contract Testing Laboratories and ensuring thorough resolution to maintain product quality and compliance. Subject matter expertise on stability-related topics during internal and external audits, inspections, and regulatory interactions. Strong background and understanding of various analytical methods such as SEC-HPLC, RP HPLC, IEX, SDS-Page, cIEF, AUC, and compendial assays as well as ELISA (Plate base assay), potency assay (cell-based assays), PCR, and testing. Proficiency in data analysis and KPI development to support quality metrics and continuous improvement. Leadership experience and project management skills to support a multi-project environment in small biotech. Strong abilities in scientific analysis and writing. Desired Competencies: Strategic thinker and demonstrate problem solving skills. Ability to interact, cooperate and motivate across departments and functions. Ability to work efficiently and make swift decisions in a fast-paced environment, adapting quickly to new challenges and priorities. Ability to prioritize and manage multiple projects simultaneously, meet deadlines, and adapt to changing priorities in a dynamic environment. Demonstrated commitment to making informed decisions based on scientific evidence and data analysis. Proactive attitude with a strong sense of ownership, accountability, and commitment to achieving the organization's goals. EEO Statement:
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.
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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 Associate Director, Quality Control 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:
Responsibility for the QC Raw Materials, and Stability programs across AAV and LVV platform and all stages of development through commercialization. Oversee stability programs to ensure timely testing, real-time trending, and generation of stability reports. Develop stability reports and summaries for inclusion in INDs, BLAs, and other regulatory submissions. Monitor, report, and escalate any trends from stability testing results to management, ensuring timely awareness and action on potential quality issues. Mentor and train team members on stability study design, execution, and data analysis techniques, fostering their professional growth and expertise in biopharmaceutical stability studies and comparability programs. Perform data review of trending for in-process testing, release, and stability and identify data trends, to ensure compliance with regulatory filings and ICH or other global health authority guidance documents. Review, approve and ensure thorough investigation of Invalid Assay(IA), out-of-specification (OOS) and out-of-trend (OOT) results, coordinating with QC teams to identify root causes and implement corrective and preventive actions (CAPAs). Manage investigations for significant deviations and quality incidents related to testing at CTL sites, ensuring thorough resolution to maintain product quality and compliance. 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. Ensure all activities are performed in accordance with GMP in Rocket laboratories and at external vendors; monitor the compliance through robust internal audit program. Ensure that all systems, laboratory controls, procedures and instructions are described adequately to enable assurance of quality of the test results generated in the QC laboratories and at external vendors. Establish proper communication channels to manage, mentor direct reports to higher levels of management capability. Partner and align with Analytical Development/Pharmaceutical Development/CMC and Program management to implement strategies and drive organizational success. Deliver results in a team-oriented setting and willing to work across scientific disciplines to drive programs through critical milestones. Plan proactively with management of other platform to ensure that resources are allocated adequately to meet each program’s needs. Write, and 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, including Plasmids, Cell Banks, Drug Substance and Drug Product 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. Qualifications:
Education/Experience and Skills Requirements: M.S. with 8 years of Quality Control experience or BS with 12 years of Quality Control experience in biotech industry and in an GMP environment. In-depth technical, regulatory understanding and experience with Gene/Cell therapy products manufacturing and testing including applicable international regulations/standards (GMP regulations, US FDA and European regulatory requirements, ICH Guidelines, and Quality System Regulations, ICH guidelines) in all phases of product development and commercialization. Including experience performing statistical analysis. Hands-on industry experience in Quality Control authoring, reviewing, and approving various release, stability of drug substance and drug product assays in GMP setting including upstream and downstream GMP Drug Substance manufacturing, and Drug product. Proven track record managing stability programs and COA processes for clinical and commercial products. Hands on experience overseeing a raw materials program. Experience writing stability reports and summaries for inclusion in INDs, BLAs, and other regulatory submissions. Experience creating, revising, and approving SOPs, and reports in accordance with current GMP, FDA, EU, Global, and ICH guidelines and regulations. Experience performing data review, including trending for in-process testing, release, and stability and identify data trends, to ensure compliance with regulatory filings and ICH or other global health authority guidance documents. Experience authoring, and approving investigations related to Invalid Assay(IA), out-of-specification (OOS) and out-of-trend (OOT) results, coordinating with QC teams to identify root causes and implement corrective and preventive actions (CAPAs). Experience managing significant deviations and quality events at Contract Testing Laboratories and ensuring thorough resolution to maintain product quality and compliance. Subject matter expertise on stability-related topics during internal and external audits, inspections, and regulatory interactions. Strong background and understanding of various analytical methods such as SEC-HPLC, RP HPLC, IEX, SDS-Page, cIEF, AUC, and compendial assays as well as ELISA (Plate base assay), potency assay (cell-based assays), PCR, and testing. Proficiency in data analysis and KPI development to support quality metrics and continuous improvement. Leadership experience and project management skills to support a multi-project environment in small biotech. Strong abilities in scientific analysis and writing. Desired Competencies: Strategic thinker and demonstrate problem solving skills. Ability to interact, cooperate and motivate across departments and functions. Ability to work efficiently and make swift decisions in a fast-paced environment, adapting quickly to new challenges and priorities. Ability to prioritize and manage multiple projects simultaneously, meet deadlines, and adapt to changing priorities in a dynamic environment. Demonstrated commitment to making informed decisions based on scientific evidence and data analysis. Proactive attitude with a strong sense of ownership, accountability, and commitment to achieving the organization's goals. EEO Statement:
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.
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