- 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
- Insmed Incorporated (Bridgewater, NJ)
- …Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewAssociate Director , Tech Ops (Process Chemistry) will have responsibility for the ... optimization, clinical/commercial manufacturing, process characterization and validation, and manufacturing CMC development strategy. Remote (only in corp. office for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Global Development Hub merges biotech speed and agility with large pharmaceutical company quality , resources , and stability, uniting the best of both worlds to ... incumbent will help develop multiple products. In doing so, the Senior Medical Director will work across different functional teams to support the design and… more
- Merck & Co. (Rahway, NJ)
- …network to enable process and formulation development.- In this position, the SMAR&D Director will set guidance, lead activities, and develop a team whose roles ... processes for non-sterile and sterile products.- It also includes strategic partnering with CMC and Regulatory in aspects of control strategy and filings, Quality… more
- Merck & Co. (Rahway, NJ)
- …accelerate process and product development and manufacturing and ensure safety and quality of our products. -The successful candidate will be accountable for ... with cross-functional development teams to enable pipeline decisions.- The Director , Biologics Analytical Research and Development (B-AR&D) is responsible for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Associate Director , Global Strategic Operations & Capacity Planning Head as part of the ... with key cross-functional stakeholders and partners (ie. supply chain, quality , alliance mgmt., finance, operations, MFG leadership and commercial) Requirements… more
- Aequor (Thousand Oaks, CA)
- …and/or AKTA chromatography, and data analytics and visualization knowledge. Job Summary: The Product Quality Director is the champion for a product team as the ... small molecule development and commercial lifecycle maintenance, product stability programs, CMC regulatory filings, risk assessment, and Quality Management… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. As a Senior Director of Quality Assurance CMC , you will be responsible for ... Engineering or related fields" + 15+ years of progressive GMP/ CMC Quality Assurance experience with 7+ years...ability to inspire and motivate direct reports at the director level and below. + Ability to work independently… more
- Teva Pharmaceuticals (West Chester, PA)
- Senior Director Regulatory Affairs CMC (Biologic Products) Date: Jun 13, 2024 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva ... to make a difference with. **The opportunity** The Sr. Director , Global Regulatory Affairs CMC is responsible...of submissions for Teva products, and for ensuring the quality of CMC response to global health… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …work and in their personal lives. Read more: careers.bms.com/working-with-us . The CMC Regulatory Associate Director , Biologics is responsible for content ... participating/leading HA meetings); and/or post-approval submissions. In this role, the GRS- CMC Associate Director , Biologics will serve as the primary… more
- Takeda Pharmaceuticals (Boston, MA)
- …to bring life-changing therapies to patients worldwide. Join Takeda as a Senior Director , GRA - CMC Pharmaceuticals- Small Molecule where you will establish ... CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs -...time. + Maintain up-to-date knowledge and expertise of relevant CMC and quality guidelines and regulations and… more
- Editas Medicine (Cambridge, MA)
- …cross-functional teams in the execution of these submissions. Key Responsibilities: + As the Director , Regulatory CMC , you will be responsible for: + Provide ... future. Position Summary This role will lead and support the CMC strategies and submission including clinical trials applications, marketing applications, agency… 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
- Regeneron Pharmaceuticals (Troy, NY)
- The Director of CMC Industry and Regulatory Intelligence is responsible for enabling chemistry manufacturing and controls ( CMC ) quality and compliance ... into action and influence policy and standards for all CMC operations across Regeneron. As a Director of CMC Industry and Regulatory Intelligence, a… more
- AbbVie (North Chicago, IL)
- …areas and stays within the approved funding. Accountable for the success and overall CMC quality of a given project. Ensures timely execution of project plan ... global filings. + Responsible for the global filings of high quality CMC dossiers, approvals and commercialization of products. Qualifications *Bachelor's Degree… more
- AbbVie (North Chicago, IL)
- …areas and stays within the approved funding. Accountable for the success and overall CMC quality of a given project. Ensures timely execution of project plan ... ADTAST/ALB and various line functions. Partners with Clinical, Regulatory, Operations, Quality , Preclinical Safety and Commercial Organizations. Apprises CMC … more
- BeiGene (Emeryville, CA)
- …stage through clinical proof of concept. + Lead cross-functional team to author CMC / quality sections of regulatory submissions (INDs/CTDs). + Building scope and ... and third parties. + Partnering and aligning with Discovery, Regulatory, Operations, Quality , and Clinical functions, and managing CMC -focused deliverables and… more
- Sanofi Group (Framingham, MA)
- … CMC by developing statistical activities, mentorship, guidance, teamwork, quality , operational efficiency, innovation and promote a productive work environment. ... discovery and development to find answers for patients and their families. The CMC -Biologics Statistics team is seeking an expert data scientist / Statistician to… more
- AbbVie (North Chicago, IL)
- …sections of regulatory submission documents of high scientific and technical quality that are compliant with global regulatory requirements. Implement well-defined, ... efficient processes for preparation, review and approval of these CMC sections. Plays a critical role in ensuring that...sections. Plays a critical role in ensuring that the CMC submission strategy is aligned closely with the clinical/regulatory… more
- AbbVie (North Chicago, IL)
- …or functions or outputs of this position. Full time/dedicated responsibility for CMC leadership and project management for commercial and pipeline small molecule ... and scope. + Lead cross-functional PDS&T product teams and represent the CMC team and/or PDS&T in interface with PDS&T leadership, other Operations functions,… more
