- 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
- Eisai, Inc (Exton, PA)
- …as well as with Facilities, Quality Assurance, Quality Control, Regulatory, and CMC Program Management departments.The Associate Director of Biologics Operations ... If this is your profile, we want to hear from you. The Associate Director of Biologics Operations Upstream and Downstream is responsible for leading and building a… more
- Formation Bio (New York, NY)
- …to patients faster and more efficiently.About the PositionWe are seeking a Senior Director , Biologics to lead all Chemistry, Manufacturing, and Controls ( CMC ) ... and regulatory leaders.Responsibilities Strategic Leadership Develop and execute comprehensive CMC strategies for pre-clinical, clinical, and commercial-stage biologic products,… more
- Merck & Co. (Rahway, NJ)
- …process comparability reports, Process performance qualification, and/or regulatory submissions. CMC RA: Experience supporting/writing regulatory filings (IND, MAA, ... (FDA, EMA, JNDA, TGA).-Leadership:-Establish and manage Cell Banking working groups, support CMC teams, and align resources to deliver on priorities. Manage and… more
- Merck & Co. (Rahway, NJ)
- …with a passion for biologics? We're looking for a dynamic and visionary- Director , Drug Substance Leader-to drive innovation and excellence across our Biologics ... Drug Substance working groups (DSWG) across the Biologics Commercialization portfolio Support CMC teams and align resources to deliver on program priorities Mentor… more
- Merck & Co. (Rahway, NJ)
- …cross-functional development teams to enable pipeline decisions. -The Executive Director , Biologics Analytical Research and Development (B-AR&D) is responsible for ... of Biologics programs (approximately 10-15 programs), and leading multiple Director lead Development teams, overall approximately 40-50 scientists. Strategic… more
- Formation Bio (New York, NY)
- …and detail-oriented Analytical Development and Quality Control biologics expert to join our CMC team. The ideal candidate will play a key role in providing technical ... in large molecule analytical development. Experience in overseeing and leading within CMC teams early to late development analytical activities for large molecule… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …globally with Formulation and Analytical Scientists, Clinical Operations, Regulatory Affairs CMC , and Clinical Development to collate the necessary information to ... author the Dose Preparation Instructions and address questions from the clinical sites. The candidate will optimize and continuously improve the Pharmacy Manual (PM) template with inputs from internal and external stakeholders. Collaboration with external… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Director , DCT Leadership position in our company's Manufacturing Division is a dedicated full-time role and is accountable for leading the DCT at ... supply chain to-achieve launch on time and uninterrupted long-term supply.Represents CMC and effectively communicates across the governance bodies, stakeholders, and… more
- Merck & Co. (Rahway, NJ)
- …regulatory submissions.-Under the general scientific and administrative direction of the Director in Biologics Cell Culture Sciences group and working in conjunction ... and communication skillsPreferred Experience and SkillsExperience in leadership of CMC development teams.Experience with cell culture process development for… more
- ACROBiosystems Inc. (Boston, MA)
- …target discovery and validation, candidate drug screening and optimization, CMC development, preclinical and clinical studies, commercial production, and companion ... customer visits, presentations, phone calls, and emails.Collaborate with the Sales Director to develop and implement territory sales plans.Foster and expand… more
- The US Pharmacopeial Convention (USP) (Rockville, MD)
- …that create an inclusive and collaborative work environment. **Brief Job Overview** **The CMC Technical Director ** is a key leadership position within an ... and tools to promote engaged, collaborative, and results-driven work environments. **The CMC Technical Director ** has the following responsibilities: * Provide… more
- Gilead Sciences, Inc. (Foster City, CA)
- …inflammation, and serious respiratory and cardiovascular conditions. **KEY RESPONSIBILITIES** The Director , CMC Regulatory Affairs for Biologics is responsible ... portfolio. This position will ensure "right first time" global approvals of CMC regulatory (Biologics) submissions, and "right to operate" by maintaining the global… more
- UTMB Health (Gatesville, TX)
- Regional Medical Director , CMC **Gatesville, Texas, United States** Physician UTMB Health Requisition # 2500313 The mission of Correctional Managed Care is to ... Texas Juvenile Justice Department (TJJD). **_JOB SUMMARY_** **:** Serves as medical director for a number of correctional facilities within a designated region.… more
- WuXi AppTec (Cranbury, NJ)
- …Pharmaceutical, a WuXi AppTec Company, has an exciting opportunity for an **Associate Director , 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 incumbent will also… more
- Takeda Pharmaceuticals (Boston, MA)
- …is possible in order to bring life-changing therapies to patients worldwide. The Director Site CMC ensures efficient and compliant management of regulatory ... scientific rationale. + Facilitate alignment between site teams and global Regulatory CMC on post-approval strategies and activities and represent global Regulatory … more
- Regeneron Pharmaceuticals (Cambridge, MA)
- Regeneron Cell Medicine is looking for an Associate Director in Regulatory CMC for biologics who will be responsible for the development and submission of ... this position you will be responsible for driving the development of innovative CMC regulatory strategies and the preparation and submission of high‑quality CMC … more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Digital Product Owner ( Director ) In Silico CMC **Location:** Cambridge, MA, Framingham, MA or Morristown NJ **About the Job** At Sanofi, we're ... new medicine to patients faster and more efficiently. As a Director -Level Product Owner for in silico CMC , you will join a dynamic team committed to driving… more
- AbbVie (North Chicago, IL)
- …high complexity utilizing a matrix approach. Leads Chemistry, Manufacturing and Controls ( CMC ) teams and Product Presentation and Device Strategy Teams (PPDST) of ... key member of AST, has accountability for creating a CMC strategy and development plan that aligns with overarching...a differentiated product. Serves as the spokesperson for all CMC functions and ensures information flow among AST and… more
- Danaher Corporation (Fargo, ND)
- …and improve human health. We are seeking a strategic and technically accomplished Director of Drug Product CMC to lead client-facing drug product development ... is critical in driving the design, development, and execution of robust CMC strategies for a diverse portfolio of clients, spanning early-phase to commercial-stage… more
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