- WuXi AppTec (Natick, MA)
- …STA Pharmaceutical, 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 stage through project completion by interacting with the client, technical team, and business development team. The… more
- Vera Therapeutics (Brisbane, CA)
- Title: Senior Manager , Early-Stage Biologics Development, CMC Location: Brisbane, CA About Us: Vera Therapeutics (Nasdaq: VERA), is a late clinical-stage ... medical treatment for patients suffering from immunological diseases. Position Summary: The Senior Manager , Early-stage Biologics Development, CMC will be… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and help create possible, together. **Job Description** **Responsibilities** + The Regulatory Affairs CMC Senior Manager at Gilead is responsible for ... providing strategic direction, tactical support, and technical expertise for CMC regulatory activities and related regulatory initiatives. + Responsible for guiding… more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- Provide CMC regulatory strategy input and expertise in the area of investigational, new and marketed biologic and small molecule drug products to assigned project ... **Job Description** + Anticipate and develop strategies and/or contingency plans for CMC related scenarios in the areas of biologic/small molecule drug substances,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the RA team ... (eg, US FDA and EU EMA) for assigned projects with support, on CMC matters. This position supports Health Authority Meetings (eg, preIND, EOP2, pre-NDA, Type… more
- University of Michigan (Brighton, MI)
- Medical Assistant Senior ( CMC ) - Brighton Center for Specialty Care Apply Now **Mission Statement** Michigan Medicine improves the health of patients, ... work group. Acts as a key administrative resource in manager 's absence. + Relates work and job purpose to...Detail** **Job Opening ID** 263624 **Working Title** Medical Assistant Senior ( CMC ) - Brighton Center for Specialty… more
- Sanofi Group (Cambridge, MA)
- **Job title** : Digital Product Owner (Associate Director/ Senior Manager ) In Silico CMC **Location:** Cambridge, MA, Framingham, MA or Morristown NJ **About ... us get new medicines to patients faster and more efficiently. As an Associate Director/ Senior Manager Product Owner for in silico CMC , you will join a… more
- Vera Therapeutics (Brisbane, CA)
- Title: Senior Manager , Process Development, Downstream Location: Brisbane, CA About Us: Vera Therapeutics (Nasdaq: VERA), is a late clinical-stage biotechnology ... treatment for patients suffering from immunological diseases. Position Summary: The Senior Manager , Process Development, Downstream will be responsible for… more
- Sumitomo Pharma (Bismarck, ND)
- …currently seeking a dynamic, highly motivated, and experienced individual for the position of ** Senior Manager , Clinical Supply Chain** . The Senior ... supplies on multiple clinical programs. In addition, working closely with CMC , Regulatory Affairs, Quality Assurance, Clinical Operations, and /or SMPA external… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …questions and drive business strategy using advanced data science and analytics. The Senior Manager , Development to Launch Analytics will join a dynamic and ... that drive our enterprise forward. Reporting directly to the Associate Director or Senior Director, Development to Launch Analytics, you will play a pivotal role in… more
- Vera Therapeutics (Brisbane, CA)
- …in the US and globally to support development programs. The Senior Manager will support both Clinical Regulatory and CMC activities. Responsibilities: * ... Title: Senior Manager , Clinical Regulatory Location: Brisbane, California About Us: Vera Therapeutics (Nasdaq: VERA), is a late clinical-stage biotechnology… more
- Lilly (Indianapolis, IN)
- …POs and invoices from vendors by effective communication between vendor, finance and CMC PM teams. + Manage the collection of performance metrics of vendors by ... early or late phase and basic technical understanding of CMC functions and roles. + Demonstrated ability to think...communication skills; able to communicate clearly and succinctly with senior leadership as well as peers and staff. +… more
- Gilead Sciences, Inc. (La Verne, CA)
- …Sciences La Verne Engineering is seeking a highly motivated and knowledgeable ** Senior Manager , Project Management New Product Line Manufacturing - Labeling** ... Packaging, Quality Assurance (QA), Quality Control (QC), Validation, Supply Chain, Regulatory/ CMC , EHS, Finance, IT, and Engineering. **Project Team Management:** +… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and help create possible, together. **Job Description** **Key Responsibilities** Senior Manager , Global External Manufacturing Biologics supports uninterrupted ... represent manufacturing on one or more cross-functional Development or Commercial CMC teams with responsibility for proactively managing product strategy across the… more
- Sumitomo Pharma (Phoenix, AZ)
- …. **Job Overview** We are currently seeking a versatile and experienced Senior Manager - Associate Director level scientist with strengths in ... of drug metabolism and bioanalytic chemistry. This position will report to Senior Director of Clinical Pharmacology and Drug Metabolism. S/he will work across… more
- The US Pharmacopeial Convention (USP) (Rockville, MD)
- …tools to promote engaged, collaborative, and results-driven work environments. _The Senior Manager , Verification Programs has the following responsibilities:_ * ... Document (CTD) for pharmaceuticals, and/or regulatory Chemistry, Manufacturing Controls ( CMC ) submission experience. * Detail oriented and good organizational and… more
- Otsuka America Pharmaceutical Inc. (Montgomery, AL)
- …with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, regulatory operations, etc.) to develop global regulatory ... plans, address global regulatory issues, health authority queries, and regulatory obligations. - Authors, coordinates, reviews, and executes submissions and responses to regulatory authorities related to INDs, amendments, supplements, aggregate reports, NDAs… more
- WuXi AppTec (St. Paul, MN)
- …oligo and peptide discovery business along with cultivating these relationships into CMC for IND enable studies with our manufacturing (CDMO) business. The candidate ... will work within the North America discovery business development team to pursue new business leads in addition to follow ups on critical issues and aid in resolving customer inquiries. **Responsibilities** + Hunting and Prospecting for oligo and peptide new… more
- Novo Nordisk (Boulder, CO)
- …water, Waste systems, compressed gases, housekeeping, life safety. Relationships Reports to Senior Manager Facilities. Essential Functions + Coach & mentor ... the Department The Boulder Site is home to the specialized technical operations/ CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the… more
- The Arora Group (Bethesda, MD)
- …Manager (RN-NCM) + National Academy of Certified Care Managers: Care Manager Certified ( CMC ) + Experience: + Referral Management/Utilization Management ... Registered Nurse Case Manager Nurse Currently recruiting a Registered Nurse (RN)...in obtaining services and support. + Serve as a senior nursing leader and advances the nursing profession in… more