Contract Manager, Quality Assurance
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 Manager, Quality Assurance responsible for in-house activities supporting Rocket's Cranbury, NJ GMP viral vector drug substance manufacturing and testing facility. The incumbent will ensure conformance to Rocket's quality standards and regulatory requirements while developing and continually improving quality systems and related processes such as validation, material control and disposition, risk management and training.
Responsibilities
Provide support for the transition from phase-appropriate to commercial expectations for site-related GMP activities
Perform product release activities, including reviews of batch records, and other documentation for product release/disposition.
Assess and approve analytical related documents, including validation protocols/reports, stability, shelf-life extension, drug substance and drug product testing data and OOS
Assess change controls for risks and impact on processes, product, and programs
Serve as QA reviewer/approver for development reports, change requests, product specifications, and product labeling
Pro-actively identify and escalate business-critical issues affecting Compliance, Operations, and Quality Assurance
Assist with preparation for FDA and other regulatory inspections
Review raw data and data summaries presented in internal reports and regulatory submissions
Work with subject matter experts to define and implement process and procedure improvements
Review and approve SOP's, specifications, and other controlled documents
Provide support with tracking and trending deviations, corrective actions, and process data
Coordinate Annual Product Quality Review, and other summary reviews
Provide support to ensure audit observations (both internal and external), changes, and corrective actions are addressed and closed in a timely manner
Support the internal audit (self-inspection) program for the facility
Provide support for reviews of product and program risk, working with subject matter experts and key stakeholders to ensure communication and timely follow-up of mitigation activities
Provide support with coordination and execute quality assurance activities during technology transfer projects
Qualifications
BS degree (minimum) in biological sciences or related field of study. Advance degree is a plus
BS with 6 + years of relevant experience in biological sciences or biotechnology
5 + years of experience with Master's degree in biological sciences or biotechnology
Preference given to candidates with +3 years of cell and gene therapy experience, in manufacturing, Quality Control or Quality Assurance
Hands-on experience in the interpretation and application of cell and gene therapy regulations and guidance documents
Thorough knowledge of cGMPs (CFR/ICH/EU) and applicable international regulations and guidelines as they apply to drug manufacturing and aseptic processing
Ability to work as part of a cross-functional team in a dynamic, fast-paced environment
Travel requirements 20%
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 Manager, Quality Assurance responsible for in-house activities supporting Rocket's Cranbury, NJ GMP viral vector drug substance manufacturing and testing facility. The incumbent will ensure conformance to Rocket's quality standards and regulatory requirements while developing and continually improving quality systems and related processes such as validation, material control and disposition, risk management and training.
Responsibilities
Provide support for the transition from phase-appropriate to commercial expectations for site-related GMP activities
Perform product release activities, including reviews of batch records, and other documentation for product release/disposition.
Assess and approve analytical related documents, including validation protocols/reports, stability, shelf-life extension, drug substance and drug product testing data and OOS
Assess change controls for risks and impact on processes, product, and programs
Serve as QA reviewer/approver for development reports, change requests, product specifications, and product labeling
Pro-actively identify and escalate business-critical issues affecting Compliance, Operations, and Quality Assurance
Assist with preparation for FDA and other regulatory inspections
Review raw data and data summaries presented in internal reports and regulatory submissions
Work with subject matter experts to define and implement process and procedure improvements
Review and approve SOP's, specifications, and other controlled documents
Provide support with tracking and trending deviations, corrective actions, and process data
Coordinate Annual Product Quality Review, and other summary reviews
Provide support to ensure audit observations (both internal and external), changes, and corrective actions are addressed and closed in a timely manner
Support the internal audit (self-inspection) program for the facility
Provide support for reviews of product and program risk, working with subject matter experts and key stakeholders to ensure communication and timely follow-up of mitigation activities
Provide support with coordination and execute quality assurance activities during technology transfer projects
Qualifications
BS degree (minimum) in biological sciences or related field of study. Advance degree is a plus
BS with 6 + years of relevant experience in biological sciences or biotechnology
5 + years of experience with Master's degree in biological sciences or biotechnology
Preference given to candidates with +3 years of cell and gene therapy experience, in manufacturing, Quality Control or Quality Assurance
Hands-on experience in the interpretation and application of cell and gene therapy regulations and guidance documents
Thorough knowledge of cGMPs (CFR/ICH/EU) and applicable international regulations and guidelines as they apply to drug manufacturing and aseptic processing
Ability to work as part of a cross-functional team in a dynamic, fast-paced environment
Travel requirements 20%
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.