- AbbVie (North Chicago, IL)
- …LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description Advance your career as Director , CMC Product Development , where you'll oversee ... champion quality and resource management. + Develops, updates, and implements CMC product development plans while ensuring regulatory, health, safety, and… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …work effectively with CDMOs. The position reports to Executive Director , CMC & Product Development . **Job Description** **Pharmaceutical Development ... Director , Formulation Development is an experienced...they will empower decision making while serving as a product development expert to all relevant internal… more
- Lilly (Indianapolis, IN)
- …a proactive leadership role in the critical review of molecule specific CMC development strategies and submission content for registration, post-approval ... Demonstrated deep technical knowledge and experience of small molecule drug product development , commercialization and manufacturing processes. + Prior… more
- Boehringer Ingelheim (Ridgefield, CT)
- …Director or Senior Associate Director to join our External Alternative CMC Development (EACD) department located at our Ridgefield, CT facility. EACD ... within the project(s), in support of CMC development within EACD. The Associate Director /Senior Associate...CMC project strategies for drug substance and drug product development accessed through external collaborations supplemented… more
- Lilly (Philadelphia, PA)
- …and advance care for patients with unmet needs. **Position Overview:** The Associate Director , CMC Development will be responsible for the execution ... of multiple radiopharmaceutical CMC development and manufacturing programs supporting various...+ Familiarity with Stage 1-3 process validation and pharmaceutical product lifecycle management. + Excellent interpersonal, verbal, and written… more
- Boehringer Ingelheim (Ridgefield, CT)
- … or Senior Associate Director , Analytical to join the External Alternative CMC Development (EACD) team at our Ridgefield, CT facility. EACD is dedicated ... relevant external scientific bodies / consortia **Compensation Data** This position, Associate Director , External Alternative CMC Development (EACD) , offers… more
- Merck (Rahway, NJ)
- …expertise in CMC regulatory strategy and dossier management activities across product development , registration, and life-cycle management. + A strong track ... plan to the Regulatory Affairs, R&D, Manufacturing and GHH management teams, product development teams, and executive management. + Establishes strong… 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
- AbbVie (North Chicago, IL)
- …& Development (R&D) organizations. Represents CMC on teams such as product development , Global Regulatory Product Teams and Operations brand teams to ... requests. + Represents CMC regulatory affairs on teams such as the product development , Global Regulatory Product Teams and Operations brand teams,… more
- Lilly (Indianapolis, IN)
- … Project Management is the program and project management arm of our critical Product Research and Development group. CMC Project Managers are responsible ... teams and therapeutic areas to translate clinical, asset and portfolio strategy into clear CMC development and delivery goals for cross-functional CMC teams.… more
- Boehringer Ingelheim (Athens, GA)
- …Boehringer Ingelheim's high regard for our employees. The Director , Scientific Expert CMC is responsible for providing new product and marketed product ... extensive experience and a high level of technical competency, ensuring that product development objectives are achieved efficiently, compliantly, and in… more
- BeOne Medicines (San Mateo, CA)
- …consistent with company goals. This individual will be responsible for development of strategies, planning, drafting, and managing CMC -related regulatory ... CMC regulatory issues and mitigation activities needed throughout product life cycle. Escalate the critical issues to senior...to senior management timely. + Lead or contribute to development of internal small molecule CMC regulatory… more
- AbbVie (North Chicago, IL)
- …a matrix management approach. + Serve as the primary Drug Product Development (DPD) representative to interface with the CMC Regulatory group. Develop ... the clinical/regulatory development strategy and provides drug development experience and advice to the CMC ...drug development experience and advice to the CMC team. Influences development of new regulatory… more
- Gilead Sciences, Inc. (Foster City, CA)
- …help create possible, together. **Job Description** **Responsibilities** **1. Strategy and Roadmap Development ** + Define and continuously refine a CMC RA ... member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we… more
- Takeda Pharmaceuticals (Boston, MA)
- …Agencies, having served as lead in successful Agency Interactions related to CMC submissions and product development meetings; international experience ... oversee the development and execution of regulatory CMC development and registration strategies. You will...Agencies having served as lead in Agency Interactions and product development meetings, international experience preferred. +… more
- Lilly (Boulder, CO)
- …Pharmaceutical Sciences, or a related field and 10 years of experience with pharmaceutical product development . Experience must include a minimum of: 8 years of ... around the world. Eli Lilly and Company seeks a Director , CMC Pharmaceutics to work collaboratively to...and commercial supply. Author and review technical documents, formulation development reports, and drug product sections for… more
- Takeda Pharmaceuticals (Boston, MA)
- …to the best of my knowledge. **Job Description** **About the role:** As a CMC Lead, Small Molecules (Associate Director ), you will be responsible for leading ... to the world. **How you will contribute:** + Provide strong direction to CMC Leads to drive effective life cycle management for Takeda's commercial small molecule… more
- Danaher Corporation (Fargo, ND)
- …for management of already established contracts and project/program execution. This position reports to the Director of Drug Product CMC and is part of the ... of life. At Aldevron, we deliver world-class CDMO services that accelerate the development of groundbreaking therapies. Our mission is to be the engine of innovation… more
- Atlantic Health System (Pompton Plains, NJ)
- …or hemolyzed blood according to approved procedures + Monitors blood and blood product inventory to ensure adequate supply for patient transfusion, orders blood and ... cost. This commitment is also echoed in the respect, development and opportunities we give to our more than...members. Offerings vary based on role level (Team Member, Director , Executive). Below is a general summary, with role-specific… more
- Bristol Myers Squibb (Devens, MA)
- …work and in their personal lives. Read more: careers.bms.com/working-with-us . The ** Director , Vector Product Champion** is accountable for leading an ... risks, and ensuring technical alignment with stakeholders. As a key member of the CMC and Global Operations (GO) Team, the Product Champion will deliver… more