Scientist, Quality Control
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
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 an Scientist QC/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.
Responsibilities
Perform various laboratory techniques that include q-PCR and/or ddPCR, ELISAs, Western Blot, Infectivity assays and in compliance with cGMPs, and Rocket's procedures
Perform routine testing of samples for release and stability, and ensure testing performed is reported within the most efficient timeframe
Perform stability data mining from external CTL LIMS and prepare data summaries
Perform QC stability data review and generate Certificate of Compliance (COC)
Executing laboratory protocols and preparing reports, as assigned.
Sub-culturing mammalian cell lines and performing cell counts
Maintaining laboratory reagents and supplies
Qualifying reagents, reference material, analytical techniques and relevant equipment
Preparing reagent aliquots and media for use in cell-based assays
Maintaining equipment in the laboratory
Conducting laboratory investigations and generating reports in response to invalid assays, deviations, OOS/OOT
Initiating and completing CAPAs in accordance with Rocket's procedures
Writing new and updating current SOPs as needed
Presenting bioanalytical data reports clearly and concisely to management
Identifying and implementing lab process improvements and lean initiative
Performing any other duties relevant to the QC laboratory position as required
Assist in planning and executing stability studies
Follow up ongoing external stability studies at CTOs and CDMOs
Author and review technical documents (protocols, reports, SOPs, test methods, memos and Impact Assessment)
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
Ensuring that all work carried out is in compliance with current GMP, the required regulatory standards, conforming to company policies and standard operating procedures (SOPs)
Laboratory maintenance and housekeeping, self-inspections and stock control.
Data trending and performing quality investigations.
Maintaining and improving knowledge of analytical techniques and procedures.
Contributing to team building, training and problem-solving initiatives internally.
Liaising with functional groups both within and outside quality control as appropriate to ensure projects and plans are progressed.
Qualifications
Education/Experience and Skills Requirements:
M.S. in Biology, Molecular Biology, Immunology with 5+ years of industry experience or BS in Biology, Immunlogy with 10+ years of relevant experience in QC/GMP environment or equivalent experience in biotechnology industry
Preferred experience with Gene/Cell therapy products for clinical and commercial AAV and LVV-based products
Knowledge and understanding 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 with mammalian cell culture including cell lines expansion, banking and cryopreservation activities for AAV and LVV
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).
Knowledge of method transfer, qualification and validation
Desired Competencies:
Analytical skills to troubleshoot and investigate issues from testing
Ability to think critically and demonstrate problem solving skills
Ability to work independently and make decisions
Effectively works in a fast-paced pharmaceutical environment
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
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
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 an Scientist QC/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.
Responsibilities
Perform various laboratory techniques that include q-PCR and/or ddPCR, ELISAs, Western Blot, Infectivity assays and in compliance with cGMPs, and Rocket's procedures
Perform routine testing of samples for release and stability, and ensure testing performed is reported within the most efficient timeframe
Perform stability data mining from external CTL LIMS and prepare data summaries
Perform QC stability data review and generate Certificate of Compliance (COC)
Executing laboratory protocols and preparing reports, as assigned.
Sub-culturing mammalian cell lines and performing cell counts
Maintaining laboratory reagents and supplies
Qualifying reagents, reference material, analytical techniques and relevant equipment
Preparing reagent aliquots and media for use in cell-based assays
Maintaining equipment in the laboratory
Conducting laboratory investigations and generating reports in response to invalid assays, deviations, OOS/OOT
Initiating and completing CAPAs in accordance with Rocket's procedures
Writing new and updating current SOPs as needed
Presenting bioanalytical data reports clearly and concisely to management
Identifying and implementing lab process improvements and lean initiative
Performing any other duties relevant to the QC laboratory position as required
Assist in planning and executing stability studies
Follow up ongoing external stability studies at CTOs and CDMOs
Author and review technical documents (protocols, reports, SOPs, test methods, memos and Impact Assessment)
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
Ensuring that all work carried out is in compliance with current GMP, the required regulatory standards, conforming to company policies and standard operating procedures (SOPs)
Laboratory maintenance and housekeeping, self-inspections and stock control.
Data trending and performing quality investigations.
Maintaining and improving knowledge of analytical techniques and procedures.
Contributing to team building, training and problem-solving initiatives internally.
Liaising with functional groups both within and outside quality control as appropriate to ensure projects and plans are progressed.
Qualifications
Education/Experience and Skills Requirements:
M.S. in Biology, Molecular Biology, Immunology with 5+ years of industry experience or BS in Biology, Immunlogy with 10+ years of relevant experience in QC/GMP environment or equivalent experience in biotechnology industry
Preferred experience with Gene/Cell therapy products for clinical and commercial AAV and LVV-based products
Knowledge and understanding 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 with mammalian cell culture including cell lines expansion, banking and cryopreservation activities for AAV and LVV
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).
Knowledge of method transfer, qualification and validation
Desired Competencies:
Analytical skills to troubleshoot and investigate issues from testing
Ability to think critically and demonstrate problem solving skills
Ability to work independently and make decisions
Effectively works in a fast-paced pharmaceutical environment
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
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.