Senior Director CMC Technical Innovation - Gene Therapies

Senior Director CMC Technical Innovation - Gene Therapies - Permanent - Massachusetts

Proclinical is seeking a Senior Director of CMC Technical Innovation to focus on Gene Therapy. This role requires a combination of CMC technical expertise (e.g. gene therapy, RNA, gene editing), effective communication, business and strategic acumen.

Primary Responsibilities:

This leader will drive technical innovation by both enhancing and leveraging our Technical Operations capabilities to maintain our position as a world leader and change driver in the industry. This role will collaborate with internal stakeholders, including but not limited to: Process Development, Analytical Development, Manufacturing, Supply Chain, Quality, R &D, Business Development, Legal (IP and contracts) and Finance, as well as external collaborators. Success in this role will be to advance Technical Operations' platform through new technology and internal inventions; technical presence through publications, conferences, collaborations and industry consortiums; and strategic opportunities identified through data analytics and sciences.

The Senior Director of CMC Technical Innovation's responsibilities will be:

• Establishes formation of a centralized innovation framework, including creation and leadership of the strategy, forum, and process that drives implementation of new technology, and streamlines IP engagement
• Expands the organization's Technical Operations presence through publications, speaking engagements participation in industry consortiums
• Screens, analyzes and negotiates potential technical collaborations from a scientific, financial and strategic perspective
• Drives identification and enablement of novel technologies and cross-functional Technical Operations improvements
• Serves as the liaison to Technical Operations scientific and business teams to provide proposals to senior leadership and prioritizes innovation in alignment with the organizational and Technical Operations strategy
• Demonstrates influential leadership capabilities and fosters a collaborative team environment
• Leads organizational initiatives and represents Technical Operations on behalf of the organization
• Participates in project related teams and other internal/external collaborations to support the client's objectives

Skills & Requirements:

• Bachelor's degree in Life Sciences or Engineering with 15+ years of relevant experience with 5+ years in a leadership role. Advanced degree preferred.
• Experience in end-to-end CMC drug development from early to late-stage development, GMP clinical and commercial operations and regulatory submissions
• Proficient in GMP, GLP and regulatory guidelines related to pharmaceutical development
• Excellent communication and interpersonal skills to help build strong relationships across scientific and business functions
• Extensive experience with the process and principles of development, technical transfer, scale up design, drug substance/drug product unit operations, and analytical methods
• Excellent listener, seeks broad input and feedback, provides frequent and effective follow up
• Solid understanding of statistical design and modeling of experiments
• Experience leading negotiations and executing agreements (e.g. material, license, etc.)
• Must have effective written and verbal communication skills

If you are having difficulty in applying or if you have any questions, please contact Dominic Williams at d.williams@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.