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 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 a Senior Manager, Quality Control/Bioassay 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.

• Overall responsible for oversight of the day-to-day operations of the QC Bioassay group within the QC Operations (Ops) department in support of our clinical and commercial AAV and LVV-based products. This includes but is not limited to cGMP routine/non-routine testing of in-process, drug substance, final product, virus banks, cell banks, in-process, lot release, stability, and raw material testing following respective procedures.
• Oversee the critical reagents, reference standard, reference control materials, laboratory supplies and analytical cell banks used for bioassays procedures across both AAV and LVV platforms.
• Support method validation and analytical technology transfer activities partnered with Analytical Development and QA.
• Perform method transfer of analytical methods that include but not limited to: Cell-based assays, Immunoassays and Ligand biding assays using PCR, Flow cytometry, and LICOR.
• Initiate, review, lead, and/or manage QMS not limited to: Change Controls, Deviations, Out of Specification, Out of Tolerance and CAPA including.
• Authors and/or reviews complex documentation such as retest/method/critical reagent protocols and reports, investigations, Impact Assessment, CMC regulatory sections, and SOPs/Form.
• Manage cell lines expansion, banking and cryopreservation activities for AAV and LVV
• Perform QC data review, generate CoAs and all related QC documents for QC release of products in accordance to Rocket’s procedure
• Monitor inventory of all reference materials and reference standard
• Initiate qualification and requalification of reference materials and reference standards, generate COA for new lots and COT after each requalification of a lot
• Management of quality system elements such as deviations, corrective and preventive actions (CAPAs), investigations, Out of Specifications (OOS), Invalid Assay (IA), Out of Trend(OOT), change controls, data integrity, and training in support of Quality Control testing, as well as audit readiness/support.
• Creation and approval of SOPs, trend data, qualification and validation protocols, reports, method validation/verifications and equipment qualifications.
• Support/Review/Approve Instrument Equipment/Instrument validation protocols and reports, as well as routine PM/annual OQ.
• Ensure all QC equipment/instrumentation is maintained in the validated state and associated logbooks compliant.
• Maintain a safe, efficient, functional and compliant cGMP laboratory according to regulatory, site and corporate guidelines.
• Interface with management on significant matters, often requiring the coordination of activity across organizational units and exercise judgment independently.
• Responsible for managing, coaching, and development of a team
• Responsible for the training of bioassay analysts and maintain proper documentation of training and transfer the records to QA. Also, ensure the team is trained to meet capacity and business continuity
• Translate complex data into actionable information and apply strong technical knowledge to meet business objectives.
• Ensure the laboratory is operated in compliance with safety guidelines, cGMPs and other applicable regulatory requirements.
• Participate in regulatory agency inspections and support site licensure.
• Establish and enable LEAN principles across all areas of responsibility.
• Identify process gaps, introduce innovative solutions, and lead operational excellence projects within QC to improve efficiency and productivity, while decreasing expense/operating costs

Education/Experience and Skills Requirements:
• PhD. in Molecular Biology or Cell Biology with 5+ years of experience; M.S. in Biology, Molecular biology, Immunology with 8+ years of industry experience in QC/GMP environment
• Preferred experience with Gene/Cell therapy products for clinical and commercial AAV and LVV-based products
• Thorough knowledge of cGMPs (CFR/ICH/EU) and applicable international regulations and guidelines as they apply to drug manufacturing, aseptic processing and quality control.
• 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.
• Experience in analytical characterization of viral vectors
• Experience overseeing critical reagents, reference standard, reference control materials, laboratory supplies and analytical cell banks used for bioassays procedures across both AAV and LVV platforms.
• Experience creating, revising, and approving SOPs, and reports in accordance with current GMP, FDA, EU, Global, and ICH guidelines and regulations.
• 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.
• Experience leading bioassay topics during internal and external audits, inspections, and regulatory interactions.
• Experience in method transfer, validation and qualification
• Experience with mammalian cell culture, including cell lines expansion, banking and cryopreservation activities for AAV and LVV
• Experience in scientific analysis and writing
• Leadership experience and project management skills to support a multi-project environment in small biotech

Desired Competencies:
• Strong analytical skills to troubleshoot and investigate analytical testing issues
• Ability to think critically and demonstrate problem solving skills
• Ability to interact, cooperate and motivate across departments and functions
• Ability to work independently and make decision
• Effectively works in a fast-paced pharmaceutical environment with prior start-up experience
• Handle issues appropriately and with a sense of urgency
• Possesses a positive, can-do attitude and creatively solves problems
• Proactive attitude with a strong sense of ownership, accountability, and commitment to achieving the organization's goals

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.