- 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)
- Job Description Position Description: Director , Business Development Responsible for leading and executing business development and commercial activities ... Analytical, Commercialization and Operations), as well as o ur Research & Development Division Process, Analytical and CMC Regulatory groups.Defines, assesses,… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the FDA to providing medical education and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps us all ... other areas as needed. Relationships Reports to a Manager, Senior Manager, Associate Director or Director . Works with personnel in other departments including… more
- AbbVie (North Chicago, IL)
- …technology, quality, regulatory/compliance requirements, budget and resources. *Multiple product development experiences of leading a CMC team through IND ... from various departments and divisions. Accountable for creating a CMC development plan in collaboration with line...needed. + Critically evaluates and integrates drug substance, drug product , and device inputs to CMC team… 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
- 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
- Lilly (Philadelphia, PA)
- …standards, and cost targets. + Collaborate with cross-functional team leaders, including development , CMC regulatory, manufacturing, and supply chain teams, to ... radiopharmaceutical development and manufacturing and incorporate them into the CMC strategy. + Mentor and develop team members, providing coaching and feedback… 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
- Boehringer Ingelheim (Ridgefield, CT)
- …EACD and is expected to support non-traditional EACD strategies for NCE CMC development accessed through external collaborations supplemented by academic ... and to sustain an innovative portfolio of technologies and processes that will advance CMC Development . As an employee of Boehringer Ingelheim, you will actively… more
- Novo Nordisk (Boulder, CO)
- …risk reporting, & overall first level of project guidance. Relationships Reports into Director , CMC Program Development . Essential Functions + Project ... With a new laboratory completed in 2021 to support analytical and process development , the CMC team works alongside Quality, Regulatory, Technical Operations and… more
- Pfizer (Groton, CT)
- …drive the analytical development strategy in full alignment with the other CMC and associated functions (Drug Product Design, Clinical and Commercial Supply ... characterize and develop drug candidates from early phases of development to commercial launch. As a Director ...relevant experience in small molecule drug substance / drug product development , or BS/MS in Analytical Chemistry,… more
