- Organon & Co. (Jersey City, NJ)
- …guidance on the pharmacokinetic performance of drug products during formulation development and the drug product life cycle, including interpretation ... knowledge-sharing events. + Contribute to and/or review the nonclinical, early clinical development or CMC documentation to support regulatory or other… more
- Insmed Incorporated (NJ)
- …personnel and internal cross-functional stakeholders across disciplines of Manufacturing, CMC , Quality, Legal, Procurement and Finance. The ideal candidate would ... and lead work groups. This position reports to the Director , Supplier Relationship Management.What You'll Do: Responsibilities:Support supplier selection sourcing… more
- 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 (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
- 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
