Quality Control, Senior Associate Scientist

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.

We are seeking a Senior Associate Scientist, Quality Control Analyst with the responsibility to support clinical manufacturing of a range of Gene Therapy products. Technical proficiency in analytical methodologies (PCR, ELISA, cell-based assays, and/ or chromatography) for drug substances and drug products is required for gene-based products.

Perform method optimization/validation and transfer of analytical methods that include but not limited to: ddPCR, qPCR, NGS, and microorganism Identification through sequence analysis. Conducts routine laboratory PCR and DNA sequencing testing and data analysis. Support daily QC operations of AAV, LVV, and Microbiology sample testing including assay execution and data analysis Follows Quality System Procedures and adheres to cGxP principles and ISO 17025 regulatory requirements Author and review technical documents (protocols, reports, SOPs, test methods, and Impact Assessments) Author and review CAPAs and Change Controls Author and assist with invalid assay, out of specification results, and associated investigations Work with cross functional peers to meet companys deadlines Perform QC data review, generate CoAs and all related QC documents for QC release of products in accordance to Rockets procedure Assure that all required QC records (testing, methods, protocols, reports, and raw data) are generated and approved Work with CMC and regulatory to provide information for the Analytical sections of IND/BLA/MAA filings/amendments Train and assist Junior QC associates in their functions

MS or BS in Biology, molecular biology, virology, Life Sciences or equivalent BS +5 or MS + 2 years of relevant experience in QC or equivalent experience in biotechnology industry Experience working in a QC environment is required Experience with Gene/Cell therapy products is preferred Experience working on clinical and commercial phase products is preferred Experience with method validation is preferred Thorough knowledge of cGMPs (CFR/ICH/EU) and applicable international regulations and guidelines as they apply to drug manufacturing and aseptic processing is preferred. Expertise in PCR technologies Strong analytical skills to troubleshoot and investigate issues from the testing Ability to work independently and make decisions. Ability to think critically and demonstrate problem solving skills Ability to multi-task to support a multi-project environment in small biotech Ability to interact, cooperate and motivate across departments and functions Effectively works in a fast-paced pharmaceutical environment with prior start-up experience preferred Handle issues appropriately and with a sense of urgency Proficiency at the lab bench to conduct product release and stability testing Must have a positive, can-do attitude and creatively solve problems

A diverse workforce fosters innovation and strengthens Rockets 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.