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 Scientist, Quality Control  Analytics with the responsibility to support clinical and commercial manufacturing of a range of AAV and LVV gene therapy products, including overseeing Contract Research Organization’s(CRO) that are responsible for testing GMP materials. Strong technical expertise in standard cell and gene therapy (CGT) analytical methodologies and strong communication and collaboration skills are necessary to succeed in this role.

• Provide support for Contract Research Organization(CRO) that are conducting GMP analytical testing for Rocket, including but not limited to PCR, ELISA and other protein detection methodologies, flow cytometry, cell-based potency, HPLC, compendial microbiological testing, particulate matter detection, and container closure integrity testing (CCIT).
• Review and approve drug substance and drug product release data, stability reports, and method qualification/validation protocols and reports
• Review data for accuracy, evaluate results against specifications, and generate certificate of analysis.
• Provide support for CRO’s investigation of invalid assay and out-of-specifications/out-of-trend results
• Provide support for CRO’s deviations and CAPAs, and technical input when necessary
• Provide support for CRO’s risk assessments and change controls to ensure changes to equipment, methods, and/or reagents do not negatively impact test method performance
• Manage sample shipping as necessary
• Participate in site audits of CRO and meetings
• Perform similar tasks as above to support internal Rocket QC operations as necessary 

• M.S. in Biology, Molecular Biology, Immunology with 3+ years’ experience with cell and gene therapy products or BS in Biology, Immunology with 4+ years of relevant biotech experience in QC/GMP environment
• 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), microbiological, particulate, and CCIT potency assays (cell-based assays), and PCR.
• Experience with method transfer, qualification and validation
• Experience in analytical characterization of viral vectors
• Experience with mammalian cell culture including cell lines expansion, banking and cryopreservation activities for AAV and LVV
• Experience  Quality Management Systems, including creating, revising, and approving SOPs, and reports in accordance with current GMP, FDA, EU, Global, and ICH guidelines and regulations.
• Knowledge and strong understanding of cGMPs (CFR/ICH/EU) and applicable international regulations and guidelines as they apply to drug manufacturing, aseptic processing and quality control
• 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).
• Strong communication and collaboration skills are required
• Ability to travel: 5-10%

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.