Gene 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. • We are actively seeking skilled and knowledgeable professionals to join our team as Gene Therapy Experts – Full Time & Per Diem. • Lead and contribute to gene therapy research and development projects from early discovery through to clinical development. • Design and execute experiments to optimize gene therapy vectors, transgene expression, and delivery systems. • Develop and implement innovative strategies to address challenges related to gene therapy vector design, manufacturing, and scalability. • Collaborate cross-functionally with research, preclinical, clinical, and regulatory teams to advance gene therapy programs. • Stay abreast of emerging technologies, scientific advancements, and regulatory requirements in the field of gene therapy. • Contribute to the preparation and review of regulatory submissions, including INDs, BLAs, and orphan drug applications. • Mentor and provide guidance to junior staff members and collaborators working on gene therapy projects.

🎯 Requirements

• PhD or equivalent degree in molecular biology, genetics, biotechnology, or related field. • Minimum of 5 years of experience in gene therapy research and development within the biotechnology or pharmaceutical industry. • Strong expertise in gene therapy vector design, optimization, and characterization. • Experience with gene editing technologies (e.g., CRISPR/Cas9) and viral vector platforms (e.g., AAV, lentivirus). • Knowledge of regulatory requirements and guidelines governing gene 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 gene therapy projects preferred but not required.