What are the responsibilities and job description for the Senior Scientist, Quality Control- Microbiology position at Rocket Pharmaceuticals?
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 a Senior Scientist, Quality Control Microbiology, with the responsibility to support clinical and commercial manufacturing of a range of AAV and LVV gene therapy products.
Responsibilities
• Perform method optimization/validation and transfer of microbiological methods that include but not limited to: Bioburden, Sterility, Endotoxin, Growth Promotion, and Organism Identification.• Experience with bioburden testing (filtration and pour plate methods), and endotoxin testing using kinetic chromogenic or gel clot techniques.• Support daily QC operations of AAV and LVV products testing.• Support daily QC microbiological monitoring of AAV/LVV manufacturing facility (utilities and environmental monitoring)• Author and review technical documents (protocols, reports, SOPs, test methods, memos and Impact Assessment)• Author and review CAPA’s and Change Controls• Author and assist with laboratory out of specifications and environmental monitoring Alert/Actions investigations.• Work with cross-functional peers to meet the company’s deadlines.• Perform QC data review, generate CoAs and all related QC documents for QC release of products in accordance with Rocket’s 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 generation of the Microbiological sections for IND/BLA/MAA filings/amendments.• Train and assist Junior QC associates in their functions.
Qualifications
Education/Experience and Skills Requirements:• PhD in Biology, Chemistry, or Molecular biology with 2 or MS with 8 years of pharmaceutical industry experience and relevant experience in QC/GMP environment or equivalent experience in the biotechnology industry• Preferred experience with Gene/Cell therapy products for clinical and commercial• Experience with Quality Management Systems, including 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 out-of-specification (OOS) and environmental monitoring excursions, and out-of-trend (OOT) results, coordinating with QC teams to identify root causes and implement corrective and preventive actions (CAPAs).• Experience in method qualification/validation and method transfer related activities.
Desired Competencies:• Thorough knowledge of cGMPs (CFR/ICH/EU) and applicable international regulations and guidelines as they apply to drug manufacturing and aseptic processing• Expertise in environmental monitoring of regulated cleanroom environments• Strong communication and collaboration skills are required.• Ability to work independently and make decisions.• Strong analytical skills to troubleshoot and investigate issues from the testing.• Ability to think critically and demonstrate problem solving skills.• Leadership experience and project management skills 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.• Stand for extended periods of time to conduct testing.• Possesses a positive, can-do attitude and creatively solves problems.
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.
