- Takeda Pharmaceuticals (Boston, MA)
- …to increase business performance, organizational efficiency while increase speed for CMC deliverables, including AI-forward projects and mindset. + Partner with PS, ... lead enterprise-wide transformation initiatives, with a focus on increasing CMC productivity of a minimum 5% per year and...productivity of a minimum 5% per year and ensure CMC costs is financially sustainable with increasing R&D portfolio.… more
- AbbVie (North Chicago, IL)
- …PDS&T Parenterals/Eye Care group is seeking a motivated Scientist as a CMC drug product project lead, specifically for parenteral drug product process development ... This position will be an integral part of the product development and CMC teams and is highly collaborative across functions such as analytical, process engineering,… more
- Gilead Sciences, Inc. (Washington, DC)
- …devices. . **Global Regulatory Excellence** Lead the development of global CMC regulatory initiatives focused on combination products and devices. Ensure regulatory ... Operations & Submissions** Oversee the drafting, review, and approval of CMC sections for regulatory filings. Provide leadership for agency interactions,… more
- Sanofi Group (Framingham, MA)
- …product transfers, process monitoring, validation, material management, facility design and CMC requirements. The role will provide scientific expertise supporting ... CMC regulatory guidance with innovative approaches to process and...started? **Main Responsibilities:** + Provide Scientific Expertise to advance CMC comparability strategy and approaches to enable health authority… more
- Lotte Biologics USA LLC (Syracuse, NY)
- …relevant conjugation chemistries and to transition bioconjugation processes from research to CMC development, as applicable, to champion manufacturing in support of ... CMC activities of ADCs + Deliver strong development experience...through commercial, including experience in late-stage activities such as CMC risk assessments, process characterization, and process validation +… more
- Lockheed Martin (Cape Canaveral, FL)
- …era in space and find a career that's built for you\. Common Missile Compartment \( CMC \) Program is looking for a highly motivated Systems Engineer to join a team of ... with other FBM Contractors and Customers in front facing meetings representing CMC Systems Engineering\. The selected candidate will be instrumental in coordinating… more
- Takeda Pharmaceuticals (Boston, MA)
- …collaboration during troubleshooting and optimization. + Author and/or review key CMC and quality deliverables, such as: + protocols, validation reports, methods, ... investigation reports and technical reports supporting submissions + Provide regulatory CMC support by authoring/reviewing drug substance (and relevant drug product)… more
- Lilly (Indianapolis, IN)
- …energetic leader who will define and lead activities with external synthetic CMC collaborations. This role will require significant CMC knowledge, creativity, ... _Ensure Alignment_ : Work closely with cross-functional leaders across Lilly CMC , Quality, Procurement, and Safety to translate PRD/SMDD strategic requirements into… more
- Genentech (South San Francisco, CA)
- …(TDL) to manage technical development team(s) in defining and implementing CMC strategies and activities associated with developing clinical candidates from ... the Technical Development Lead (TDL) and technical teams to define the CMC strategy and objectives for 3-5 projects across various platforms (large/small molecules,… more
- Lilly (Indianapolis, IN)
- …in a collaborative and fast-paced work environment. + Lead and oversee CMC process development activities for novel payloads and drug-linkers within ADC programs, ... ensure manufacturability and facilitate smooth transition from early research to CMC development. + Develop scalable, robust, and reproducible processes for payload… more
Recent Jobs
-
Chaplain
- Trinity Health (Plymouth, IN)
-
Field Engineer - Automated Logic
- Carrier (Lisle, IL)
-
Senior Analyst, Financial Intelligence Unit
- Scotiabank (Dallas, TX)
-
Senior Product Manager
- IBM (Bellevue, WA)