- Merck & Co. (Rahway, NJ)
- …in CMC regulatory strategy and dossier management activities across product development , registration, and life-cycle management.A strong track record of ... to the Regulatory Affairs, R&D, Manufacturing and GHH management teams, product development teams, and executive management.Establishes strong cross-functional… more
- Merck & Co. (Rahway, NJ)
- …Regulatory, Quality, Compliance, Supply Chain and Commercial. Understanding of product development lifecycle and integration of CMC and clinical strategy and ... of brand operating metrics. The VCM PL will partner with the Product Development Team (PDT), Development and Commercialization Team (DCT), and Global… more
- Insmed Incorporated (San Diego, CA)
- …regulatory review of documentation prepared by other technical functions supporting product development activities (eg, clinical protocols, clinical study ... RAC certification desired10+ years of experience in Regulatory Affairs, and product development experience within the pharmaceutical or biotechnology industry,… more
- Merck & Co. (Rahway, NJ)
- …activities/projects - Willingness to grow and learn all areas of Pharmaceutical new product development - - Preferred Experience and Skills: - Medical Device ... Director , Engineering, Packaging Commercialization will lead packaging development for new products including parenteral products including small molecules,… more
- 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
