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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 engagementExpands the organization's Technical Operations presence through publications, speaking engagements participation in industry consortiumsScreens, analyzes and negotiates potential technical collaborations from a scientific, financial and strategic perspectiveDrives identification and enablement of novel technologies and cross-functional Technical Operations improvementsServes 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 strategyDemonstrates influential leadership capabilities and fosters a collaborative team environmentLeads organizational initiatives and represents Technical Operations on behalf of the organizationParticipates 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 submissionsProficient in GMP, GLP and regulatory guidelines related to pharmaceutical developmentExcellent communication and interpersonal skills to help build strong relationships across scientific and business functionsExtensive experience with the process and principles of development, technical transfer, scale up design, drug substance/drug product unit operations, and analytical methodsExcellent listener, seeks broad input and feedback, provides frequent and effective follow upSolid understanding of statistical design and modeling of experimentsExperience 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.
