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Category: Medical Device
Location:
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. Visit us atwww.pharmavise.com
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.
Qualifications:
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.
We offer competitive compensation packages, including comprehensive benefits for full-time positions, and flexible scheduling options for per diem roles.
Be part of our network of Subject Matter Experts.
EEO Employer:
PharmaviseConsulting Corp. is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law.PharmaviseConsulting Corp. will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require accommodation in using our website for a search or application, please .
PharmaviseConsulting Corp. is a regulatory compliance consulting firm that partners with Pharmaceutical, Medical Device and Biotechnology clients. When you joinPharmavise, you become part of a team that values Excellence Through Quality.
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