- Merck & Co. (North Wales, PA)
- …is responsible for developing and implementing Chemistry, Manufacturing, and Controls ( CMC ) regulatory strategies for our organization's biologics product ... the probability of regulatory success together with risk mitigation measures.Lead the development , communication, and review of the CMC Regulatory Strategy… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …or to the governance bodies. Responsibilities - Accountability to lead teams within overall CMC development project(s), to support Sr CMC Lead. In case ... early and late phase drug development candidates within the team to support overall CMC development plan.- Represent CMC development project teams on… more
- Novo Nordisk Inc. (Boulder, CO)
- …reporting, & overall first level of project guidance. Relationships Reports into Director , CMC Program Development . Essential Functions Project Management ... With a new laboratory completed in 2021 to support analytical and process development , the CMC team works alongside Quality, Regulatory, Technical Operations and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …including (mAb, Drug Substance, Drug Product , or New Modality) process and product development preferred Travel Ability to travel up to 30%. Global and ... activities across the projects for (mAb, Drug Substance, Drug Product , or New Modality) manufacturing, evaluates CMC ...and associated teams for internal and external sites and development projects. Serve as the main interface to internal… more
- Merck & Co. (Rahway, NJ)
- …to a diverse and inclusive work environment.Knowledge, Duties & Responsibilities for the Director Include:Oral drug product development concepts, tools, and ... mindset, and collaboration with various partners and stakeholders in development is expected.The Director will report to...step across boundaries, and implement novel innovations during drug product development to enable the best science… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionFLEx is a set of multi-modality Drug Product development and GMP clinical manufacturing assets being constructed in the Rahway, New Jersey site, ... collaborative scientific community that inspires innovation and enables speed of new product development from clinical research to commercialization of robustly… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …engineering, science, or related field. Minimum 8+ years of industrial biologics CMC development or manufacturing experience, CAR-T experience is highly ... in the treatment of multiple myeloma. Legend Biotech is seeking Associate Director , Global Strategy & Investigations Owner/Lead as part of the Technical Operations… more
- Merck & Co. (North Wales, PA)
- …The leader will interact with our cross-divisional/functional teams from development through commercialization to ensure implementation of the designed quality ... policies as well as other divisional policies related to management of product quality.Implement a fit-for-purpose QMS, ensuring end-to end quality oversight of New… more
- AbbVie (North Chicago, IL)
- …with respect to science, time, budget and resources. + Develops and implements a CMC product development plan and updates as necessary in collaboration ... from various departments and divisions. Accountable for creating a CMC development plan in collaboration with line...convenience + Critically evaluates and integrates drug substance, drug product , and device inputs to CMC team… more
- Merck (North Wales, PA)
- …is responsible for developing and implementing Chemistry, Manufacturing, and Controls ( CMC ) regulatory strategies for our organization's biologics product ... success together with risk mitigation measures. + Lead the development , communication, and review of the CMC ... in-license/due diligence review, product divestment and product withdrawal. + Support new technology development .… more
- Teva Pharmaceuticals (West Chester, PA)
- …regulatory colleagues to prepare dossiers for global registration. + Identify and evaluate CMC issues associated with product development including ... Senior Director , Regulatory Affairs CMC , Innovative...+ Relevant technical experience in Analytical (QC, Analytical R&D), process/ product development , or manufacturing + Knowledge of… more
- Taiho Oncology (Pleasanton, CA)
- Director , Regulatory Affairs CMC Pleasanton, CA, USA Req #355 Tuesday, March 26, 2024 Looking for a chance to make a meaningful difference in the oncology space? ... and expanding mid-size oncology company in the role of Director , Regulatory CMC , reporting directly...Inc., (TOI) projects; provides strategic regulatory guidance especially for CMC during drug development , approval and post… more
- Lilly (Indianapolis, IN)
- …strategy based upon global regulatory changes. + Provide regulatory guidance to allow CMC development teams to make well-informed decisions on development ... + Takes a proactive leadership role in the critical review of molecule specific CMC development strategies and submission content. + Makes decisions on CMC… more
- Merck (Rahway, NJ)
- …in CMC regulatory strategy and dossier management activities across product development , registration, and life-cycle management. Present and influence key ... mitigation, and overall plan to the GRACS, R&D, Manufacturing, GHH management team, product development teams (PDT), and executive management, as relevant. +… more
- Takeda Pharmaceuticals (Boston, MA)
- …organization to think proactively and utilize science and risk based approach to product development and LCM activities. + Contribute to creating and ... CMC experience including experience as an RA CMC product lead, or equivalent industry experience,...Agencies having served as lead in Agency Interactions and product development meetings, international experience preferred. +… more
- Amicus Therapeutics (Marlow, OK)
- …Certification (eg RAC) Professional Work Experience Requirements . 7-10 years' experience in CMC product development , regulatory . Experience in managing ... Associate Director CMC RA Location Marlow, UK...Affairs, Technical Operations, Science and Quality Assurance . Ensure CMC development strategies are aligned with global… more
- Editas Medicine (Cambridge, MA)
- …including but not limited to developing regulatory strategy and plan for CMC development , assessing regulatory scenarios risks and opportunities, proposing risk ... functional teams to provide regulatory guidance and support for CMC development and ensure compliance with applicable...is preferred. + A broad understanding of the drug product development process is required. + This… more
- Lilly (Indianapolis, IN)
- …and evolving global regulatory expectations + Provide regulatory guidance to allow CMC development teams to make well-informed decisions on development ... + Takes a proactive leadership role in the critical review of molecule specific CMC development strategies and submission content + Makes risk-based decisions on… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …or to the governance bodies. **Responsibilities** - Accountability to lead teams within overall CMC development project(s), to support Sr CMC Lead. In case ... early and late phase drug development candidates within the team to support overall CMC development plan. - Represent CMC development project teams… more
- BeiGene (San Mateo, CA)
- …cell therapy development . Ideal candidate must be proficient in both CMC strategic planning, execution, and matrix team management. The successful applicant will ... cell therapies is a plus. + Broad understanding of all aspects of CMC including process development , regulatory and quality requirements, analytical … more
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