Location: Cranbury,NJ, USA
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 for an Associate Director, Quality Control - Method Validation with the responsibility to support clinical and commercial manufacturing of a range of AAV and LVV gene therapy products.
Responsibilities
* Design and oversee validation of various analytical methods including but not limited to PCR, ELISA, potency, infectivity, chromatography, and compendial for Rocket's AAV and LVV programs in the QC lab in a manner compliant with ICH Q2(R2).
* Define the strategy and oversee the execution of method transfer from the Rocket Analytical Development (AD) lab to the Rocket QC lab.
* Define the strategy and oversee the execution of method validations at CROs.
* Serve as a technical SME to assist with investigation of invalid assays and out-of-specification test results.
* Author and review analytical methods, validation protocols, validation reports, and SOPS.
* Author and review Quality Management System (QMS) documents (deviations, CAPAs, change controls, gap/risk/impact assessments) as necessary.
* Ensure that QC decisions are aligned with Rocket's QMS and regulatory requirements including but not limited to:
* Qualification of analytical cell banks
* Qualification of reference standards and assay controls
* Qualification of critical reagents used in analytical methods
* Data review
* Partner and align with the AD, CMC, and Program Management departments to meet the objectives of each program plan.
* Plan strategically with other QC managers to ensure that resources are allocated adequately to execute the validations.
* Prepare source documents and compile data sets for Regulatory and CMC teams to support regulatory filings (e.g. IND, BLA)
* Evaluate new technologies for method optimization.
* Identify gaps and assist with annual QC budget (OPEX and CAPEX).
Qualifications
Education/Experience
* PhD. in Molecular Biology, Cell Biology, Immunology or related field with 8 years of experience in QC or equivalent experience in the biotechnology industry; M.S. with 10 years of experience GMP environment and with cell gene therapy product or BS with 12 years of experience.
Required and Preferred Competencies:
* Familiarity with ICH Q2 (R2) and other regulatory documents (e.g. USP, EP, ICH, FDA guidelines) relevant to method validation is required.
* Strong technical writing skills are required.
* Strong analytical skills to troubleshoot and investigate aberrant test results is required.
* Ability to collaborate and motivate across departments and within QC is required.
* Ability to work in a fast-paced pharmaceutical GMP environment is required.
* Experience with Cell and Gene Therapy (CGT) products in clinical and commercial phases is preferred.
* Leadership experience and project management skills to support a multi-project environment is preferred.
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.