Title: Principal Scientist-AD & QC

　　Location: Philadelphia, Pa

　　Schedule: M-F 8am-5pm

　　Type: Permanent/Direct

　　Start date: Immediate

　　Our Client is a start-up CDMO that delivers promising cell and gene therapies to our partners addressing some of life’s most challenging and rare diseases. Based in Philadelphia—the epicenter of cell and gene therapy innovation—the company is uniquely positioned to provide research, process development, manufacturing, and CMC services to help biotech and biopharmaceutical companies advance their cell and gene therapy candidates from discovery through the clinic. Be part of our expanding success, centered on a commitment to deliver world-class, cutting-edge therapeutics with exceptional client service and support.

　　Responsibilities:

　　Set up lab procedures, equipment, and materials for Cell-Based assays and molecular biology assays at ADQC group.

　　Develop, and qualify, optimize, and validate cell-based assays and molecular biology methods for release and characterization of drug substance, products and manufacture process.

　　Establish specifications and testing protocols for raw materials, intermediates, and final drug products, ensuring compliance with regulatory standards and guidelines.

　　Author original technical documents including Standard operating Procedures (SOP's), protocols, technical reports, and applicable regulatory submissions.

　　Collaborate closely with Process Development and Manufacturing teams to optimize analytical methods for in-process monitoring and product release testing.

　　Design and execute experiments to evaluate the performance and reliability of analytical methods, ensuring accuracy, precision, specificity, and sensitivity according to ICH Q2 and Q14 guidance.

　　Validate analytical methods for the analysis of raw materials, intermediates, and finished products in accordance with regulatory guidelines.

　　Conduct testing to support in- process characterization, stability, and release of cell and gene therapy products.

　　Own troubleshooting, deviations, non-conformance (OOT/OOS) investigations, CAPA’s, and change controls associated with analytical and QC operations for cell-based group.

　　Train and supervise ADQC employees on areas of expertise, and provide operational, technical, and quality oversight of QC testing.

　　Serve as SME in site audits and client meetings, review of regulatory submissions.

　　This position is hands on, and you will spend most of your time in the lab.

　　Requirements:

　　Education: Master’s degree or other advanced degree in Biology, Biochemistry, Virology, Microbiology or related discipline.

　　Experience: At least 5 years of experience in a GMP pharmaceutical setting, performing both AD and QC functions.

　　Extensive knowledge and hands-on experience with cell culture, bio-separations methods, cell-based assays for potency and replication competence, and digital PCR, and real-time PCR.

　　Demonstrated success developing, qualifying, and validating assays/methods.

　　Scientific background related to viral vectors (e.g., Lentivirus, AAV) is strongly preferred.

　　Strong understanding of cGMP, GLP ICH/ FDA guidelines, and phase appropriate requirement for product development is required.

　　Excellent written and verbal communication skills, with the ability to author original technical documents including Standard operating Procedures (SOP's), Protocols, and technical reports.

　　System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services 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 full-time 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.