Quality Control, Senior Associate Scientist
Apply NowCompany: Rocket Pharmaceuticals, Inc.
Location: Cranbury, NJ 08512
Description:
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
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.
Responsibilities
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 company's deadlines
Perform QC data review, generate CoAs and all related QC documents for QC release of products in accordance to 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 Analytical sections of IND/BLA/MAA filings/amendments
Train and assist Junior QC associates in their functions
Qualifications
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
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.
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
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.
Responsibilities
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 company's deadlines
Perform QC data review, generate CoAs and all related QC documents for QC release of products in accordance to 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 Analytical sections of IND/BLA/MAA filings/amendments
Train and assist Junior QC associates in their functions
Qualifications
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
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.