Job Title: Senior Scientist, Cell Processing (Cell Therapy Process Development)
Location: Princeton, NJ 08540
Duration: 03 Months

Shift: Monday - Friday, 8:00 AM - 5:00 PM (Onsite Position)

Position Overview:

We are actively seeking a Senior Scientist specializing in Cell Therapy Process Development to support the development of early and late-stage clinical manufacturing processes. This role is crucial in the technology transfer and process optimization of internal and client-related projects. The ideal candidate will leverage expertise in modern bioprocess methodologies, including Design of Experiment (DoE) and Quality by Design (QbD), to deliver innovative and efficient solutions in cell therapy manufacturing.

Key Responsibilities:

• Process Development:

  • Develop and optimize cell therapy manufacturing processes from scratch or by enhancing existing methodologies.
  • Apply Quality by Design (QbD) and Design of Experiments (DoE) to improve capacity and reduce manufacturing costs.
  • Define Target Product Profile (TPP) and identify Critical Process Parameters (CPP) and Critical Quality Attributes (CQA).

• Technology Transfer:

  • Lead and assist in technology transfer, GAP analysis, and process industrialization of client projects.
  • Act as the key point of contact for product/process support during technology transfers and cGMP drug product manufacturing.

• Innovative Technology Integration:

  • Identify and assess new technologies to enhance product quality, reproducibility, and cost/time efficiency in manufacturing processes.

• Client and Cross-functional Collaboration:

  • Collaborate with internal Manufacturing (MFG), Analytical Development (AD), Quality Control (QC), and Quality Assurance (QA) teams and external client SMEs.
  • Support business development and project management teams during technical discussions with prospects and clients.
  • Author and provide technical documentation such as CMC sections, SOPs, risk assessments, and batch records.

• Supervision and Training:

  • Mentor and supervise junior staff, creating a high-performance team environment.

• Troubleshooting & Problem Solving:

  • Investigate deviations and assess product impact for projects employing developed processes.
  • Coordinate with QC/AD teams for analytical method development and product characterization.

• Documentation & Communication:

  • Maintain high-quality documentation and communicate effectively across cross-functional teams, clients, and stakeholders.

• Travel:

  • Occasional domestic or international travel may be required to support client-facing or project-related activities.

Education and Experience Requirements:

• BS with 8+ years, MS with 6+ years, or Ph.D. with 4+ years of relevant experience in biotechnology or cell therapy industries.
• Strong background in cell therapy process development and bioprocess development.
• Experience with QbD, DoE, and various cell therapy technologies.

Preferred Knowledge and Skills:

• Proficiency with cell therapy manufacturing equipment such as Sepax, Lovo, G-Rex, Xuri Bioreactors, CliniMACS Plus/Prodigy, MaxCyte GT.
• Familiarity with nucleic acid/viral vector transduction/transfection.
• Hands-on experience with flow cytometry, PCR, and cell-based assays.
• Strong organizational, problem-solving, and attention-to-detail skills.
• Experience with GMP and aseptic processing.