Cell Therapy Expert

February 11

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Pharmavise Corporation

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Pharmavise Corporation is the first Continuous Compliance Organization (CCO) dedicated to maintaining the highest standards of quality and regulatory compliance in the life sciences industry. Our esteemed client base includes Fortune 500 companies in pharmaceuticals, medical devices, and biotechnology. We offer bespoke solutions tailored to meet the specific compliance needs of our clients, supporting them from development through commercialization and ensuring they exceed their compliance goals while enhancing patient health and safety.

FDA Compliance Consulting • Project Management • Auditing • External Supply Operations • Quality Systems Management

11 - 50 employees

Founded 2013

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• This is a remote position. • From development to commercialization, we partner with Pharmaceutical, Medical Device and Biotechnology clients to provide solutions to complex compliance issues. • We collaborate with our partners by providing technical expertise in Quality, Regulatory Compliance and Manufacturing Science and Technology. • Our business mission is to ensure our clients exceed their compliance goals while improving patient health and safety. • 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.

🎯 Requirements

• 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. • 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