- Programmable Medicine Operatin (Redwood City, CA)
- …Oversee the execution of activities associated with injectable and solid oral drug product development and manufacturing, supporting clinical development and ... to focus on leading our contract manufacturing efforts including Drug Substance and Drug Product . The successful candidate will be required to work on site 5 days… 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
- Danaher Corporation (Fargo, ND)
- …that safeguard and improve human health. We are seeking a strategic and technically accomplished Director of Drug Product CMC to lead client-facing drug ... + Serve as the primary CMC technical lead for drug product development projects, acting as a key liaison between clients and internal cross-functional teams.… more
- AbbVie (North Chicago, IL)
- …Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Pharma Product Group Director will be fully responsible for providing CMC leadership and ... initiatives. + Independently lead complex and/or hybrid cross-functional PDS&T product teams. Represent the CMC team and/or...with at least 12+ years of relevant experience. + CMC development experience through IND and/or NDA/MAA.… 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
- 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 (North Wales, PA)
- … Development and Commercialization Teams (DCTs) responsible for building and executing CMC development plans. Under the guidance of the CIPM Staff Manager ... Development & Commercialization Teams (~70%)** + Able to independently manage CMC development projects of any type, including those which require extensive… 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
- Gilead Sciences, Inc. (Foster City, CA)
- …inflammation, and serious respiratory and cardiovascular conditions. **KEY RESPONSIBILITIES** The Director , CMC Regulatory Affairs for Biologics is responsible ... multiple products. + Lead the execution and influence the development of global CMC regulatory strategies, including...risk mitigation strategies to ensure right first-time approvals of product submissions. + Lead the execution of these global… more
- Bristol Myers Squibb (Indianapolis, IN)
- …leader in radiopharmaceuticals . We are seeking an experienced and motivated **Senior Director , Regulatory Affairs - CMC (Manufacturing)** . This position will ... Application (NDA), and Marketing Authorization Application (MAA) submissions + Lead the development and execution of global CMC regulatory strategies for… 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)
- …scientific knowledge, and company policies and procedures. + Develops and implement CMC regulatory strategies, guiding teams across product lifecycle stages. + ... 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
- 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
- Organon & Co. (Jersey City, NJ)
- …basis. Primary responsibilities include, but are not limited to: **Responsibilities** + Serve as the CMC Product Lead or support the CMC Product Lead ... Principal Scientist will lead the preparation and submission of CMC dossiers for programs in clinical development ,...of all regulatory milestones for assigned products through the product lifecycle. + Lead development and execution… 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
