- 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
- 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
- J&J Family of Companies (Horsham, PA)
- …of America **Job Description:** We are searching for the best talent for a ** Senior Manager , Product Quality Integrator, Launch & Grow Biotherapeutics** , to be ... step of the way. Learn more at https://www.jnj.com/innovative-medicine. **Purpose:** The Senior Manager , Product Quality Integrator, Launch and Grow… 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
- 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
- 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
- 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
- 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
- Mallinckrodt Pharmaceuticals (Hazelwood, MO)
- Job Title Manager , Analytical Chemistry Requisition JR000014958 Manager , Analytical Chemistry (Open) Location Hazelwood, MO Additional Locations St. Louis, MO ... Job Description Summary Job Description The Manager , Analytical Chemistry, offers the opportunity to play a...regulatory submissions by drafting relevant sections, such as the CMC portions for FDA submissions, CTDs, and other global… more
- Gilead Sciences, Inc. (Foster City, CA)
- …the care of patients with life-threatening diseases. The **Sr. Clinical Supply Manager ** is a leader that inspires teams while providing expertise for Gilead's ... external partners to resolve shipping related issues; Escalates to senior leadership as needed . Partners with Quality Assurance.... Revise and author SOPs and Work instructions with manager direction and support . Obtain and review quotes,… more