Head of Analytical
Philadelphia, PA
Experience: 0
Category: Scientific & Clinical
Brand: Joule
Job ID: 300243
Date Posted: 09/15/2023
Shortcut: http://jobs.systemone.com/TafTjh
Title: Head of Analytical - Cell and Gene Therapy
Location: Philadelphia, PA
Type: Direct Hire
Start date: ASAP
Overview:
Our client is a CDMO whose focus is in the Cell and Gene Therapy field. They are looking for a Director of QC and Analytical Services to develop laboratory procedures and build out Laboratory Services. Ideal candidates will have a working knowledge of bioassay analytical development, QC, and assay technical transfers within the cell and gene therapy space, as well as experience creating laboratory SOPs, GMPs and other requirements, processes and procedures.
Responsibilities:
- Supporting a build-out of a facility and team of scientists conducting analytical development, quality control, and assay technical transfer (molecular team, biochemical team, bioassay team, physical/chemical team, and quality control (QC) team
- Oversee analytical development and testing activities as well as ensure appropriate training and documentation for bioassays
- Authoring and reviewing development and technical reports, SOPs and test records, study reports, qualification reports, and relevant sections of regulatory submissions and participating in the establishment of electronic information systems
- Overseeing QC functions, including QC testing, analytical testing, and stability programs
- Oversee the development, conduct, and qualification as necessary of assays to evaluate viral vector drug substance and drug product concentration purity, identity, and infectivity
- Oversee the conduct of analytical studies such as biodistribution and shedding and testing for stability studies. Analytical testing may be conducted as research testing or as GLP/GMP testing with Quality Assurance oversight
- Build and manage strong relationships with vendors and external suppliers in support of technical and clinical operations.
Requirements:
- Bachelor’s/Master’s degree with 10-15 years of experience or Ph.D. with 8-10 years
- Working knowledge of methods and assays such as ddPCR, qPCR, ELISA, TCID50, and RCAAV to oversee development and testing activities as well as ensure appropriate training and documentation (technical reports, test records)
- Strong Technical writing skills
- Must have knowledge of molecular and/or biochemical and/or cell-based assays for the characterization of biological products
- Must have a thorough understanding of GxP and of CMC regulatory guidance for the manufacturing and testing of gene therapy products
Our client provides a comprehensive benefits package; competitive salaries plus bonus, medical, dental, vision, PTO
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, and MOUNTAIN, LTD., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
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