Process Development Scientist

Hybrid (East Hanover, NJ 2-5 times a week)

1 year contract (high likelihood of extension)

As a member of the Technical Development group, this individual will manage and own current and future Cell and Gene development projects and contribute to interdisciplinary technical development work in the larger CGT organization. The candidate will act as a subject matter expert for cell therapies projects, interpret and communicate results, evaluate data, draw relevant conclusions and write protocols, reports, and other source documents for regulatory submissions. Contribute to risk analyses and/or peer review and process challenge meetings.

Daily Expectations:

•Perform experimental design, protocol development and execution, data analysis, technical report writing and presentation.

•Provide scientific/technical leadership for efficient and robust processes for the manufacture and/or analysis of intermediates, drug substances and drug products as per own discipline.

•Report and present of scientific/technical work at internal/external meetings/conferences and publish in peer reviewed international scientific journals including patents.

•Assume scientific/technical key function in teams, projects, networks, platforms and/or department activities.

•Delivery on project milestones, including technical presentations, development reports and other documents relevant to GMP operations.

•Adherence to company standards, in particular, quality, ethical, health, safety, and environment (HSE), and information security (ISEC) standards.

•Feedback from other team leaders and advisory boards.

•Refer to annual individual and team objective setting.

•Outcome of risk analyses, process challenge meetings, audits and inspections.

•Measurable contributions to the success, efficiency and productivity of the department and new programs/initiatives started and implemented. Contributions to management decision making and advisory boards.

•Internal and external publications/presentations invited lectures. Internal/external awards.

Qualifications:

•Bachelor’s degree with 5 years of industry experience OR master's degree with 3 years of industry experience OR a PhD with 1 years relevant experience in Immunology/Cell Therapy

•Scientific background and understanding of CAR-T manufacturing and development process scale up and scale down

•Recognized expertise in immunology, cell biology, biomarker identification, clinical research

•Demonstrated record of accomplishment in fostering innovation and creative problem-solving

•Experience with primary cell isolation and maintenance.

•Demonstrated history of working on team-oriented projects, managing team members

•Strong communication/presentation skills and scientific/technical writing skills.