- Merck & Co. (Rahway, NJ)
- …process comparability reports, Process performance qualification, and/or regulatory submissions. CMC RA: Experience supporting/writing regulatory filings (IND, MAA, ... (FDA, EMA, JNDA, TGA).-Leadership:-Establish and manage Cell Banking working groups, support CMC teams, and align resources to deliver on priorities. Manage and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …globally with Formulation and Analytical Scientists, Clinical Operations, Regulatory Affairs CMC , and Clinical Development to collate the necessary information to ... author the Dose Preparation Instructions and address questions from the clinical sites. The candidate will optimize and continuously improve the Pharmacy Manual (PM) template with inputs from internal and external stakeholders. Collaboration with external… more
- Merck & Co. (Rahway, NJ)
- …with a passion for biologics? We're looking for a dynamic and visionary- Director , Drug Substance Leader-to drive innovation and excellence across our Biologics ... working groups (DSWG) across the Biologics Commercialization portfolio Support CMC teams and align resources to deliver on program...working a Hybrid work consisting of three total days on- site per week, Monday - Thursday, although the specific… more
- Merck & Co. (Rahway, NJ)
- …process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients ... as well as supply chain documentation to support critical CMC activities.-- Support the collection of clinical supply chain...working a Hybrid work consisting of three total days on- site per week, Monday - Thursday, although the specific… more
- Merck & Co. (Rahway, NJ)
- …cross-functional development teams to enable pipeline decisions. -The Executive Director , Biologics Analytical Research and Development (B-AR&D) is responsible for ... of Biologics programs (approximately 10-15 programs), and leading multiple Director lead Development teams, overall approximately 40-50 scientists. Strategic… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Director , DCT Leadership position in our company's Manufacturing Division is a dedicated full-time role and is accountable for leading the DCT at ... supply chain to-achieve launch on time and uninterrupted long-term supply.Represents CMC and effectively communicates across the governance bodies, stakeholders, and… more
- Takeda Pharmaceuticals (Boston, MA)
- …what is possible in order to bring life-changing therapies to patients worldwide. The Director Site CMC ensures efficient and compliant management of ... on risk and scientific rationale. + Facilitate alignment between site teams and global Regulatory CMC on...alignment between site teams and global Regulatory CMC on post-approval strategies and activities and represent global… more
- Lilly (Indianapolis, IN)
- …strategies impacting product submissions across geographies and networks for alignment with CMC team members. + Engage in site -specific regulatory activities to ... the world. Lilly is looking for post approval regulatory CMC scientists to join us in delivering life-changing new...who need them all over the world. The Senior Advisor/ Director Post approval scientist in Global Regulatory Affairs -… more
- Bristol Myers Squibb (Indianapolis, IN)
- …aims to be the global leader in radiopharmaceuticals. **Summary** The Associate Director of Chemistry, Manufacturing & Controls ( CMC ) - Quality Assurance ... develops and drives Quality (manufacturing and analytical) strategies for CMC activities (drug substance, API, drug product, and analytics) for compounds in… more
- AbbVie (North Chicago, IL)
- …high complexity utilizing a matrix approach. Leads Chemistry, Manufacturing and Controls ( CMC ) teams and Product Presentation and Device Strategy Teams (PPDST) of ... key member of AST, has accountability for creating a CMC strategy and development plan that aligns with overarching...level. Qualifications *This position will be required to sit on- site 3 days / week* Qualifications: + Bachelor's Degree… more
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