Remote Cell Therapy Scientist – R&D & Manufacturing

Pharmavise Corporation; United States; Teletrabalho; USD 150 000 - 190 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Comprehensive benefits

Per diem options

Resumo da oferta

PharmaviseConsulting Corp. is a fully remote role partnering with Pharmaceutical, Medical Device and Biotechnology clients to ensure compliance and manufacturing excellence.

You will lead cell therapy R&D, design manufacturing processes, and mentor a跨-functional team to advance programs toward clinical trials and commercialization. The position requires a PhD with 5+ years in cell therapy, strong GMP knowledge, and a track record in regulatory submissions.

Qualificações

• PhD or equivalent in related field.
• Min 5 years in cell therapy R&D in biotech/pharma.
• Strong cell culture and engineering expertise.
• Experience with GMP manufacturing and QC/QA.
• Knowledge of FDA/EMA guidelines.
• Excellent analytical and collaboration skills.

Responsabilidades

• Lead and contribute to cell therapy research and development projects.
• Design and optimize cell therapy manufacturing processes, including cell isolation, expansion, differentiation, and characterization.
• Develop innovative strategies to enhance the efficacy, safety, and scalability of cell therapy products.
• Collaborate cross-functionally with research, translational, clinical, and regulatory teams to advance cell therapy programs from preclinical development through to clinical trials and commercialization.
• Stay abreast of emerging technologies, scientific advancements, and regulatory requirements in the field of cell therapy.
• Contribute to the preparation and review of regulatory submissions, including INDs, BLAs, and marketing authorization applications.
• Mentor and provide guidance to junior staff members and collaborators working on cell therapy projects.

Conhecimentos

Cell culture techniques

Cell engineering

Cell-based assays

Regulatory knowledge

Analytical skills

Problem-solving

Leadership experience

Effective communication

Formação académica

PhD or equivalent in cell biology/immunology/regen medicine

Descrição da oferta de emprego

PharmaviseConsulting Corp. is a fully remote role partnering with Pharmaceutical, Medical Device and Biotechnology clients to ensure compliance and manufacturing excellence.

You will lead cell therapy R&D, design manufacturing processes, and mentor a跨-functional team to advance programs toward clinical trials and commercialization. The position requires a PhD with 5+ years in cell therapy, strong GMP knowledge, and a track record in regulatory submissions.