- Daiichi Sankyo, Inc. (Bernards, 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
- ACROBiosystems Inc. (New York, NY)
- …target discovery and validation, candidate drug screening and optimization, CMC development, preclinical and clinical studies, commercial production, and companion ... and encouraging cross-functional collaboration and continuous learning. Job Summary The Senior Sales Specialist will lead commercial activities in the states of… more
- Merck & Co. (Rahway, NJ)
- …the business.-- - - Working independently, the Protocol Clinical Supplies Project Manager ( Protocol CSPM) designs strategic and operational plans for all activities ... process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients… more
- Merck & Co. (Rahway, NJ)
- …arms within the business.-- - - The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS point of contact ... process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients… more
- Merck & Co. (Rahway, NJ)
- …Management Section of the GCS Planning organization. -Working independently, the Inventory Manager Clinical Supplies Project Manager (IM CSPM) creates strategic ... process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients… more
- 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
- AbbVie (Waltham, MA)
- …and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls ( CMC ) works with ... internal and external partners to deliver products to patients. Prepares CMC regulatory strategies that enable first pass approvals. Develops and manages content… more
- Gilead Sciences, Inc. (Foster City, CA)
- …robust CMC regulatory strategies. + Under the guidance of more senior staff, oversees the preparation of CMC regulatory submissions for investigational ... with manager support. + Invests in acquiring knowledge about CMC regulatory intelligence including guidelines and regulatory trends. **Basic Qualifications:** +… more
- BeOne Medicines (San Mateo, CA)
- …be responsible for development of strategies, planning, drafting, and managing CMC -related regulatory submissions and HA interactions to meet the aggressive ... projects. The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on relevant topics. **Essential… 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. (Bismarck, ND)
- …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
- BeOne Medicines (Pennington, NJ)
- Reporting to the Vice President, General Manager of US Manufacturing, Hopewell, NJ., this position plays a leading role in driving process robustness, technology ... process troubleshooting. This position involves close collaboration with the CMC , Process Development, Manufacturing, Quality Control, Quality Assurance and… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …purpose of this position to act as a team member in the product manager area of Regulatory Affairs (Biopharma) supporting global submissions for various areas of the ... required. **Additional Responsibilities, Knowledge, Skills and Abilities:** + Global Regulatory CMC Experience is preferred. + Ability to work independently and… more
- Bristol Myers Squibb (Seattle, WA)
- …by re-engaging the body's immune system to treat cancer. We are looking for a Manager / Senior Engineer to join the Breyanzi Product Stewardship Cell Therapy ... of Summit, NJ, USA or Seattle, WA, USA. This senior engineer will be responsible for the implementation of...global level. This highly cross-functional role collaborates across all CMC functional areas and drug product manufacturing sites to… more
- POWER Engineers (Appleton, WI)
- ** Senior Field P&C Engineer** Location **Milwaukee** Secondary Locations **Appleton, Eau Claire, Green Bay, Madison** Job Code **18514** \# of openings **1** Apply ... resume. This position reports to the Midwest Region Department Manager or Area Lead. Under the guidance of an...Relay test sets including, but not limited to, Omicron CMC 256/356 or Doble F6150 and associated software (ex.… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- Senior Quality Control Analyst Department: Chemistry Location: Monroe, NC START YOUR APPLICATION ... Control (QC) Lab at the Monroe manufacturing facility, reporting to the QC Manager . Primary responsibilities for this position will be: perform QC analysis in… more
- Merck (Rahway, NJ)
- …within the business. Working independently, the Protocol Clinical Supplies Project Manager (Protocol CSPM) designs strategic and operational plans for all activities ... process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients… more
- Merck (West Point, PA)
- …the operational/executional arms within the business. The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS point of ... process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients… more
- Merck (West Point, PA)
- …Management Section of the GCS Planning organization. Working independently, the Inventory Manager Clinical Supplies Project Manager (IM CSPM) creates strategic ... process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …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
Related Job Searches:
CMC,
CMC Manager,
Manager,
Senior,
Senior Manager,
Senior Manager CMC Global,
Senior Manager CMC Regulatory,
Senior Project Manager CMC