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. Visit us at www.pharmavise.com
We are actively seeking skilled and knowledgeable professionals to join our team as Gene Therapy Experts – Full Time & Per Diem. Below, you'll find a comprehensive job description detailing the responsibilities, qualifications, and expectations for this role:
Responsibilities:
- 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.
Qualifications:
- 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.
We offer competitive compensation packages, including comprehensive benefits for full-time positions, and flexible scheduling options for per diem roles.
EEO Employer:
Pharmavise Consulting 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. Pharmavise Consulting 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 contact info@pharmavise.com.
Pharmavise Consulting Corp. is a regulatory compliance consulting firm that partners with Pharmaceutical, Medical Device and Biotechnology clients. When you join Pharmavise, you become part of a team that values Excellence Through Quality.
