- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Director , Engineering, Packaging Commercialization will lead packaging development for new products including parenteral products ... erience developing and commercializing new products on cross-functional teams. - - The Associate Director will be accountable for the d efinition and execution… more
- AbbVie (North Chicago, IL)
- …(https://www.tiktok.com/@abbvie) . Job Description The Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls ( CMC ) works with ... CMC development of peptides and sterile injectables. This individual prepares CMC regulatory strategies that enable first pass approvals. Develops and… more
- BeOne Medicines (San Mateo, CA)
- …assigned projects. The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on relevant topics. ... **Essential Functions of the job:** + Lead, develop and implement small molecule CMC regulatory strategies as well as authoring CTD CMC sections for the… more
- Boehringer Ingelheim (Ridgefield, CT)
- …currently seeking an Associate Director or Senior Associate Director to join our External Alternative CMC Development (EACD) department located at ... activities within the project(s), in support of CMC development within EACD. The Associate Director /Senior Associate Director of EACD for drug… more
- Lilly (Philadelphia, PA)
- …new medicines, and advance care for patients with unmet needs. **Position Overview:** The Associate Director , CMC Development will be responsible for the ... Process Development, Analytical Sciences, Manufacturing, Quality, Supply Chain, R&D, Finance, and Regulatory to ensure delivery of CMC milestones for priority… more
- Boehringer Ingelheim (Ridgefield, CT)
- …seeking an experienced Associate Director or Senior Associate Director , Analytical to join the External Alternative CMC Development (EACD) team at ... and relevant external scientific bodies / consortia **Compensation Data** This position, Associate Director , External Alternative CMC Development (EACD) ,… more
- AbbVie (North Chicago, IL)
- …external third parties. The primary function is to ensure consistent preparation of CMC regulatory submission documents of high scientific and technical quality ... strong negotiating, influencing, and leadership skills. + Manages completion of CMC regulatory submission documentation for multiple projects of moderate… more
- Takeda Pharmaceuticals (Boston, MA)
- …is true to the best of my knowledge. **Job Description** **About the role:** As a CMC Lead, Small Molecules ( Associate Director ), you will be responsible for ... to the world. **How you will contribute:** + Provide strong direction to CMC Leads to drive effective life cycle management for Takeda's commercial small molecule… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …and company goals and objectives. Essential Functions: + Develop and Execute Global Regulatory Strategies: Formulate and lead global CMC and clinical ... compliance with FDA, EMA, and Health Canada regulations. Assess regulatory impact of changes in CMC procedures...regulations. Assess regulatory impact of changes in CMC procedures and oversee internal regulatory guidance… more
- CSL Behring (King Of Prussia, PA)
- …therapies that make a meaningful difference worldwide. Could you be our next Associate Director Global Regulatory Lead, EHT (Enabling Healthcare Technologies ... connects and maintains relationships with GRAST members, including GRAS Regions and Regulatory CMC . *Applies the CSL Leadership Capabilities - Build Bridges,… more
- Lilly (Philadelphia, PA)
- …determined to make life better for people around the world. **Position Overview:** The Associate Director , Supply Chain will lead and grow a supply chain team ... of approved suppliers, products, and components + Review technical and regulatory documentation to ensure accuracy, consistency, and currency of all critical… more
- Otsuka America Pharmaceutical Inc. (Salem, OR)
- ** Associate Director , Small Molecule Analytical Development** + Lead and oversee phase appropriate method development and optimization for drug substance and ... drug substance and drug product ensuring compliance with relevant ICH and regulatory guidelines + Develop and implement stability study protocols and timelines,… more
- Takeda Pharmaceuticals (Boston, MA)
- …application is true to the best of my knowledge. **Job Description** **Title: Associate Director -Process Engineer SM API Process Sci** **Location: Cambridge, MA ... (Hybrid)** **About the role:** As an Associate Director -Process Engineer SM API Process Sci,...o Other key functional groups such as Global Quality, Regulatory CMC etc. **Leadership** + Provide vision… more
- BeOne Medicines (Emeryville, CA)
- …to lead our Research, Supply Production and Financial Analytics Initiatives. The Associate Director Research, Supply Production and Financial Analytics, Data ... tools for early discovery and translational research, supply readiness, CMC , cross-functional resource utilization, vendor performance and cost scenario modeling… more
- US Tech Solutions (Holly Springs, NC)
- …new Drug Substance production facility. Responsible for also being able to enable CMC Regulatory file drafting and support, commissioning and qualification of ... Scale-up, Clinical & Commercial Manufacturing Support, Process Performance Qualification (PPQ), CMC Regulatory file drafting and support, commissioning and… more
- Sanofi Group (Framingham, MA)
- **Job Title:** GRA Device Lead ( Associate Director ) **Location** : Morristown, NJ/ Cambridge, MA/ Framingham, MA **About the Job** Are you ready to shape the ... critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse...of products. The team is part of the GRA CMC & GRA Device Department within Global R&D. The… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** GRA Device Lead ( Associate Director ) **Location:** Cambridge, MA/ Morristown, NJ **About the Job** Are you ready to shape the future of medicine? ... critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse...of products. The team is part of the GRA CMC & GRA Device Department within Global R&D. The… more
- J&J Family of Companies (Raritan, NJ)
- …as a single submission. **We are searching for the best talent for an Associate Director , Submission Program Management Lead to be located in Raritan, NJ; ... SPML will be a key partner to the Global Regulatory Leader (GRL), Compound Development Team Leader (CDTL) and...near critical path (eg, LPO, DBL, TLR/TLG, CSR, Non-Clinical, CMC ) into ISP. + Maintaining and communicating execution level… more
- University of Southern California (Los Angeles, CA)
- cGMP Associate Director , Process DevelopmentApply (https://usc.wd5.myworkdayjobs.com/ExternalUSCCareers/job/Los-Angeles-CA Health-Sciences-Campus/cGMP- ... cell and gene therapies and other biological products for internal/external users. The Associate Director of Process Development (cGMP) is responsible for all… more
- Merck (West Point, PA)
- **Job Description** The Associate Director , Engineering, Packaging Commercialization will lead packaging development for new products including parenteral ... prior experience developing and commercializing new products on cross-functional teams. The Associate Director will be accountable for the definition and… more
