- Xeris Pharmaceuticals, Inc. (Chicago, IL)
- …provides subject matter expertise for all aspects of Drug Substance (API), Drug Product , and Combination/Device product development against the applicable ... **Overview** The Director , CMC provides leadership for the...questions. + Supports the preparation and management of complex CMC development plans including long-range planning. +… 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 (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
- Boehringer Ingelheim (Duluth, 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
- 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
- Amgen (Washington, DC)
- …to CMC data, spanning drug substance, drug product , and delivery device development . As Director , CMC Modeling & Advanced Statistics, you will: + ... CMC development and commercial support. Reporting to the Senior Director , CMC Statistics, you will drive innovation in kinetic modeling, Bayesian… 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
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