- AbbVie (North Chicago, IL)
- …The PDS&T Parenterals/Eye Care group is seeking a motivated Senior Scientist as a CMC drug product project lead , specifically for parenteral drug product ... commercial. + Lead cross-functional PDS&T product teams and represent the CMC team and/or PDS&T in interface with PDS&T leadership, other Operations functions,… more
- Sanofi Group (Swiftwater, PA)
- **Job Title:** GRA CMC Lead , Vaccines **Location** : Swiftwater, PA, Morristown, NJ **About the Job** Are you ready to shape the future of medicine? The race is ... of GRA. + Provide leadership, guidance, and coordination to project teams of GRA CMC professionals in...and coordination to project teams of GRA CMC professionals in delivering specific development and marketed product… more
- Takeda Pharmaceuticals (Lexington, MA)
- …regulatory CMC investigational and/or registration strategies for assigned products as GRA CMC Product Lead and/or team lead . Assigned products include ... regulatory requirements and standards. + When in a GRA CMC Product Team lead role, prepares and...within a complex matrix environment in GRA with GRLs, CMC RA project leads and other GRA… more
- Gilead Sciences, Inc. (Foster City, CA)
- …into Pharmaceutical Development & Manufacturing (PDM) Project teams. **JOB DESCRIPTION** + Lead CMC regulatory strategy for a single or multiple products. + ... Regulatory Affairs, PDM, and other functional groups across Gilead. + Lead CMC strategies, assess risks, and develop contingency plans, including major, complex… more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- …requirements for CMC and GMP related submissions and inquiries. + Represents CMC RA in project team meetings and provides regulatory guidance and perspective ... to the cross-functional team in conjunction with global regulatory lead (s). + Prepare, coordinate and/or review all CMC and GMP related documents for submission… more
- Lilly (Indianapolis, IN)
- …Applications, post-approval supplements/ variations and responses to questions. **Oversight of CMC Project Deliverables** + Ensures appropriate definition and ... qualified for the work assigned to them and the project responsibilities associated with their position. + Ensures that...external environment. + Utilizes scientific and regulatory knowledge to lead preparation, review, and finalization of CMC … more
- Vera Therapeutics (Brisbane, CA)
- …as a subject matter expert and lead for all aspects of lead drug candidate development, including CMC developability, cell line development, process ... to change the standard of care for patients. Vera's lead product candidate is atacicept, a fully humanized fusion...relevant sections for regulatory submissions. * Participate and represent CMC Process Development in project teams. *… more
- AbbVie (South San Francisco, CA)
- …deliverables and help drive drugs substance purification development strategy though program lead assignments in cross-functional CMC teams. This position is an ... Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Biologics CMC Development team at AbbVie in the Bay Area has a long… more
- Sanofi Group (Waltham, MA)
- …Statistician- Vaccines **Location:** Waltham, MA **About the Job** As an experienced mRNA CMC Principal Statistician, you will lead and coordinate the team ... CoE Data and Computational Science team in platform and project technical teams as statistical CMC subject...and participates in the drafting of patent filings + Lead preparation and publication of scientific papers and congress… more
- AbbVie (North Chicago, IL)
- …etc.) and genetic medicine (AAV, LNPs, Cell Therapy). We are looking for a Biologics CMC Data Strategy Lead who will develop, oversee and drive the data and ... Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description Biologics CMC , a part of Development Sciences within AbbVie's R&D, is a… more
- The US Pharmacopeial Convention (USP) (Rockville, MD)
- …continuous improvements based on new evidence / information, and programmatic experience. * Lead CMC work group, comprised of regional technical experts in ... product development, and technology transfer. The Technical Director will lead a team of about 5-6 technical staff and...* Provide leadership for the management and implementation of CMC -related technical activities for a donor-funded project ,… more
- GE Aerospace (West Chester, OH)
- …aviation aircraft, there is a career for you with us. In this role, the CMC Repair Materials Strategy Leader will own the strategy and execution of Ceramic Matrix ... Composite ( CMC ) and Environmental Barrier Coating (EBC) repair development programs...function to help arrive at a decision. + May lead functional teams or projects with moderate resource requirements,… more
- GE Aerospace (Batesville, MS)
- **Job Description Summary** The Lead CMC Process Specialist will own all aspects of 5 Axis grinding process(es) within the assigned functional area and drive the ... + Demonstrated ability to analyze and resolve problems + Demonstrated ability to lead programs / projects with established project management skills + Humble:… more
- WuXi AppTec (Natick, MA)
- …a WuXi AppTec Company, has an exciting opportunity for a **Manager/Senior Manager, CMC Project Management.** This position will be responsible for managing DS ... and DP projects within STA. The position will lead the orderly progression of projects from the proposal...orderly progression of projects from the proposal stage through project completion by interacting with the client, technical team,… more
- GE Aerospace (Huntsville, AL)
- **Job Description Summary** The CMC HK Obeya Leader will support the Value Stream Integration Leader in driving cross-functional integration, prioritization, ... will focus on leading the Aerospace HK Priorities for CMC 's, which include GE9X CMC component yield...standards. + **Delivery:** Manage and prioritize tasks to meet project deadlines and deliverables. Collaborate with cross-functional teams to… more
- Astellas Pharma (Northbrook, IL)
- …multi-country packaging strategies and policies for the Americas. As a member of global CMC teams, this person will lead all aspects of package material ... **Director CMC Development PRTL Packaging & Device US** Do...+ Provides leadership, and guidance to direct reports and project team members in an effort to develop strong… more
- Astellas Pharma (South San Francisco, CA)
- …visit our website: www.astellasgenetherapies.com. **The Role:** The Scientist II will take a lead in developing and transferring assays for the GMP release of drug ... + Collaborate with research group to develop first-in-class drugs. + Lead product characterization activities for gene therapy products. + Troubleshoot problems… more
- UTMB Health (Huntsville, TX)
- Acquisition Specialist - CMC - Huntsville **Huntsville, Texas, United States** Business, Managerial & Finance UTMB Health Requisition # 2502658 The mission of ... JOB FUNCTIONS_** **:** + Assists Customers in procurement planning and project coordination by providing budgetary/cost analysis, sourcing, technical & commercial… more
- LGC Group (Petaluma, CA)
- …closely with its customers to assist the identification and development of lead candidates with a broad suite of bioinformatics, biology, chemistry, manufacturing ... support, release of raw materials and investigation as required to maintain project timelines. Qualifications + Bachelor's degree in Chemistry or the Life Sciences,… more
- Qualus (Pensacola, FL)
- …schedule management + Work with Area Sponsor/P&C Project Sponsor, Operations Team, and CMC Area Lead PM to ensure project alignment + Oversee, manage, ... relaying in the field. + Serve as a technical lead for small project teams. + Own...P&C commissioning process, including remote ends + Report to CMC Manager of Project Management + Own… more