- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders. Summary CMC Lead is responsible for supporting the overall CMC strategies within ... and the respective development stage of the project. The CMC Lead will support the Sr. CMC ...with other sub projects with respect to supply, product quality and stakeholder satisfactions. Responsible to communicate and escalate… more
- Merck & Co. (Rahway, NJ)
- …high rigor in CMC regulatory strategy as well as delivery of high- quality CMC submissions for products which could span traditional solid-oral small ... while developing and expanding your career.The Chemistry, Manufacturing & Controls ( CMC ) Pre-approval Pharm Executive Director is accountable for managing… more
- Merck & Co. (North Wales, PA)
- Job DescriptionUnder general supervision of an Executive Director /Senior Director , the Principal Scientist / Director is responsible for developing and ... implementing Chemistry, Manufacturing, and Controls ( CMC ) regulatory strategies for our organization's biologics product franchises in accordance with domestic and… more
- Novo Nordisk Inc. (Boulder, CO)
- …new laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality , Regulatory, Technical Operations and RNAi ... reporting, & overall first level of project guidance. Relationships Reports into Director , CMC Program Development. Essential Functions Project Management Lead… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC ... for working on cross-functional teams, developing and executing post-approval Regulatory CMC strategies, reviewing CMC information and data, authoring … more
- Merck & Co. (North Wales, PA)
- …are compliant and support approval of new modality regulatory filings.our Technical CMC teams for end-to-end Quality oversight/support of New Modalities ... Description: Reporting to the AVP of New Modalities our Manufacturing Division Quality , this leader is responsible for supporting the implementation of a unique… more
- Merck & Co. (Rahway, NJ)
- …stakeholders across the organizations (Research Division/Manufacturing Division), such as Analytical, Quality , Regulatory CMC , and technical functions, to ensure ... a range of modalities including small molecules and peptides.- Within OFS, the Director will influence the strategy, lead activities, and develop a team whose roles… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position Summary The Director of Project Management will lead a team of project management professionals ensure projects are executed effectively and efficiently ... that projects are delivered on time, within budget, and according to quality standards Establish pathways for escalation of program and project issues within… more
- Novo Nordisk Inc. (Boulder, CO)
- …new laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality , Regulatory, Technical Operations and RNAi ... raw materials and API candidates in our portfolio. Relationships Reports to Senior Director , Chemical Development (within the CMC team). Essential Functions The… more
- Novo Nordisk Inc. (Boulder, CO)
- …new laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality , Regulatory, Technical Operations and RNAi ... 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
- FUJIFILM Holdings America Corporation (Boston, MA)
- Overview The Associate Director / Director of Business Development, will be an ambitious salesperson who independently works to identify, qualify, negotiate, and ... and facilitate site visitsWork closely and collaboratively with Project Management, Quality , Technical Operations, R&D and other relevant groups to lead generation… more
- Option Care Health (Trenton, NJ)
- …developing, and retaining a diverse workforce. Job Description Summary:The Regional Director , Operations is responsible for delivering safe, efficient and effective ... all operational aspects in multiple Option Care Health Care Management Centers ( CMC ) while meeting all corporate compliance and other established rules and… more
- Citizens Medical Center (Victoria, TX)
- …modality certifications, under the direction of a radiologist and / or the Director of Radiology, performs radiographic procedures at a technical level not requiring ... patient needs and supports colleagues and associates in providing quality patient carePreferred: NoneLICENSURE / CERTIFICATION REQUIREMENTSRequired:Current license with… more
- Taiho Oncology (Pleasanton, CA)
- Director , Regulatory Affairs CMC Pleasanton, CA,...truly global experience that helps cancer patients to improve quality of life . The size of our company ... Proposition: Join our dynamic and expanding mid-size oncology company in the role of Director , Regulatory CMC , reporting directly to Executive Director ,… more
- Merck (North Wales, PA)
- **Job Description** Under general supervision of an Executive Director /Senior Director , the Principal Scientist / Director is responsible for developing and ... implementing Chemistry, Manufacturing, and Controls ( CMC ) regulatory strategies for our organization's biologics product franchises in accordance with domestic and… more
- Teva Pharmaceuticals (West Chester, PA)
- Senior Director , Regulatory Affairs CMC , Innovative...of submissions for Teva products, and for ensuring the quality of CMC response to global health ... to make a difference with. **The opportunity** The Senior Director , Regulatory Affairs CMC is responsible to...you will: + Influence the strategy and assess the quality of documents for regulatory submissions to major market… more
- Merck (Rahway, NJ)
- …high rigor in CMC regulatory strategy as well as delivery of high- quality CMC submissions for products which could span traditional solid-oral small ... while developing and expanding your career. The Chemistry, Manufacturing & Controls ( CMC ) Pre-approval Pharm Executive Director is accountable for managing a… more
- Amicus Therapeutics (Marlow, OK)
- Associate Director CMC RA Location Marlow, UK Requisition ID 2246 # of openings 1 Apply Now ... (https://phh.tbe.taleo.net/phh04/ats/careers/v2/applyRequisition?org=AMICUS&cws=37&rid=1290) Job Brief Associate Director CMC RA Amicus Therapeutics is a global,… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as a Director , GRA CMC Pharmaceuticals, Oligonucleotides where you will lead the GRA ... and right first time. Maintain up-to-date knowledge and expertise of relevant CMC and quality guidelines and regulations and establishes mechanisms to… more
- Takeda Pharmaceuticals (Boston, MA)
- …order to bring life-changing therapies to patients worldwide. Join Takeda as a Director , Regulatory Affairs Vaccines CMC where you will provide program ... leadership and develop CMC regulatory strategy for global vaccine programs in various...on cross-functional Takeda Vaccines teams (commercial, clinical development, delivery, quality , etc.) to ensure that data are identified, obtained… more
