Pharmavise Corporation · 1 month ago
Cell Therapy Experts – Full Time & Per Diem
Pharmavise Corporation is a regulatory compliance consulting firm that partners with Pharmaceutical, Medical Device and Biotechnology clients. They are seeking Cell Therapy Experts to lead and contribute to research and development projects aimed at advancing novel cellular therapies, while collaborating with various teams to ensure compliance and enhance product efficacy.
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Responsibilities
Lead and contribute to cell therapy research and development projects aimed at advancing novel cellular therapies for various diseases and conditions
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
Qualification
Required
PhD or equivalent degree in cell biology, immunology, regenerative medicine, or related field
Minimum of 5 years of experience in cell therapy research and development within the biotechnology or pharmaceutical industry
Strong expertise in cell culture techniques, cell engineering, and cell-based assays
Experience with cell therapy manufacturing processes, including GMP requirements and quality control/assurance
Knowledge of regulatory requirements and guidelines governing cell therapy product development (e.g., FDA, EMA)
Excellent analytical and problem-solving skills, with the ability to design and interpret complex experiments
Effective communication and collaboration skills, with the ability to work in a fast-paced, team-oriented environment
Preferred
Leadership experience and a track record of successfully leading cell therapy projects preferred but not required
Benefits
Competitive compensation packages
Comprehensive benefits for full-time positions
Flexible scheduling options for per diem roles