Title: Senior Scientist, Cell Processing

Location: Princeton NJ

Schedule: Monday through Friday 8-5 on site

Duration 3-month Contract to Hire

Responsibilities:

• Work experience in cell therapy process development, manufacturing science, analytical development, and familiarity with GMP/FDA/ICH guidelines.

• Develop and optimize cell therapy manufacturing processes from scratch or using existing processes.

• Apply Quality by Design (QbD) methodology and Design of Experiments (DoE) approach in development to maximize capacity and reduce cost of goods.

• Assist in defining Target Product Profile (TPP), identifying Critical Process Parameters (CPP) and Critical Quality Attributes (CQA).

• Lead and assist in technology transfer, GAP analysis, process industrialization of client projects

• Identify, assess, and implement new technologies to improve product quality, success rate, reproducibility and/or reduce cost and time of manufacturing processes.

• Act as the accountable point of contact from the process development for product/process support for technology transfers and ongoing cGMP drug product manufacturing.

• Responsible for trouble shooting, deviation investigation and product impact assessment for projects employing developed technology/processes.

• Coordinate with AD/QC team in analytical method development and characterization of products that are currently in development.

• Organize and prioritize work to meet timelines and ability to execute on multiple projects. Support client facing activities for the cell therapy process development team.

• Support Business and Project Management team for technical discussion with prospects/clients.

• Provide appropriate documentation and support clients in authoring CMC sections.

• Demonstrate strong oral and written communication skills. Author protocols, reports, risk assessments, SOPs, and batch records.

• Supervise, train and mentor junior staff to create a high performing team.

• Occasional domestic or international travel will be required.

  Requirements:

• BS with 8+ years, MS with 6+ years OR Ph.D. and 4+ years of experience in a biotechnology, cell therapy industry

• Experience of cell therapy process development is a must

• Expertise in bioprocess development, QbD and DoE methodology

• Knowledge in various cell therapy/culture technologies

• Experience with common equipment used in cell therapy manufacturing such as Sepax, Lovo, G-Rex, Xuri Bioreactors, CliniMACs Plus, CliniMACS Prodigy, MaxCyte GT

• Good organizational and problem-solving skills, and attention to detail.

• Experience in GMP and Aseptic processing is preferred.

• Experience with nucleic acid/viral vector transduction/transfection is preferred.

• Hands-on experience with flow, PCR and cell-based assays is a plus.

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.