- Daiichi Sankyo, Inc. (Bernards, 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 ... project needs and the respective development stage of the project. The CMC Lead will support the Sr. CMC Lead on complex and/or late-stage project or act as main… more
- 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC Portfolio Products, will be responsible for ... regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio...working on cross-functional teams, developing and executing post-approval Regulatory CMC strategies, reviewing CMC information and data,… more
- Novo Nordisk Inc. (Boulder, CO)
- …are driving change. Are you ready to make a difference? The Position The Associate Director , Process Chemistry will be responsible for the design, development ... development and scaling of small molecules, oligonucleotide intermediates and API's. The Associate Director is expected to implement novel strategies towards… more
- Tris Pharma (Monmouth Junction, NJ)
- …have an immediate opening in our Monmouth Junction, NJ facility for an Associate Director , Alliance Management.Tris Pharma has a long track record of ... spanning many departments across all stages of the product lifecycle. The Associate Director , Alliance Management will be accountable for managing alliances… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …our program partner Janssen. This effort will extend to joint technical and CMC committees that report to the Joint Manufacturing Committee in the commercial ... efforts worldwide.Key Responsibilities Represent MSAT at joint technical and CMC committeesPartner closely with senior leadership to achieve global alignment… more
- Merck & Co. (Rahway, NJ)
- …oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team ... portfolio and influence bridging strategies across the portfolio. The Biopharmaceutics Director will work with their direct reports to proactively develop and… more
- Merck & Co. (Rahway, NJ)
- …portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team ... with key stakeholders across the organizations such as Quality, Regulatory CMC , and technical functions, to ensure timebound progression of portfolio, initiatives… more
- Insmed Incorporated (San Diego, CA)
- …Millennials™, and Best Medium Workplaces™ lists.OverviewJoin the Technical Operations team as Associate Director of MSAT where you will support pipeline programs ... process of manufacturing AAV based therapies. Working closely with Process Development and CMC teams you will be the bridge between the laboratory and GMP… more
- Lilly (Philadelphia, PA)
- …determined to make life better for people around the world. **Position Overview:** The Associate Director - CMC Regulatory is responsible for leading global ... diagnostic radiopharmaceutical products. This includes the delivery of all relevant CMC regulatory submissions in addition to assessing country-specific CMC … more
- AbbVie (North Chicago, IL)
- …@abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Purpose: The Associate Director in CMC Statistics is responsible for providing ... in nonclinical areas with a focus on Chemistry, Manufacture and Control ( CMC ), expanding and broadening the application of Biostatistics. He/she is also responsible… more
- UTMB Health (Huntsville, TX)
- Associate Director , Laboratory Services - CMC - Estelle Unit **Huntsville, Texas, United States** Clinical Laboratory UTMB Health Requisition # 2400470 The ... supervision for Correctional Managed Care Laboratory Services. Assists the Medical Director in the overall direction and management of Correctional Managed Care… more
- Takeda Pharmaceuticals (Lexington, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director , Global Regulatory Affairs CMC where you will develop ... and lead the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products....CMC team, you will report to a Senior Director and work with stakeholders across the business. **How… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders. **Summary** CMC Lead is responsible for supporting the overall CMC strategies within ... project needs and the respective development stage of the project. The CMC Lead will support the Sr. CMC Lead on complex and/or late-stage project or act as main… more
- AbbVie (North Chicago, IL)
- …Implement well-defined, efficient processes for preparation, review and approval of these CMC sections. Plays a critical role in ensuring that the CMC ... development strategy and provide drug development experience and advice to the CMC team. Influence development of new regulatory guidance, assure timely impact… 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 ... (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
- Frontier Medicines (South San Francisco, CA)
- Join Frontier Medicines on an exciting journey as our newest Senior Manager/ Associate Director in CMC Development, located at either our Boston or South San ... of our team, reporting directly to the Head of CMC , you'll play an integral role in advancing our...capsules, and spray dried dispersions. + Fostering collaboration with CMC , DMPK, Chemistry and Discovery R&D teams + Conducting… more
- Actalent (Branford, CT)
- …IS HIRING FOR AN ASSOCIATE DIRECTOR OF FORMULATIONS! Title: Associate Director , Formulation R&D Department: CMC (Chemistry, Manufacturing, and ... Controls) Location: Branford, CT Position Summary: Responsible for leading and directing the formulation design and development of pre-clinical and clinical development candidates. Collaborates with vendors, provides technical guidance, and oversees critical… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Join Gilead and help create possible, together. **Job Description** The Associate Director , Analytical Regulatory Science, collaborates with product development, ... flexibility the incumbent will support "right first time" global approvals for CMC control strategies and maintain "right to operate" throughout the product… more
- Regeneron Pharmaceuticals (Troy, NY)
- …preferably related to health, environment or politics or related degree and: + Associate Director : 15+ years of related experience in regulated industry or ... The Director of CMC Industry and Regulatory...The Director of CMC Industry and Regulatory Intelligence is responsible for...into action and influence policy and standards for all CMC operations across Regeneron. As a Director … more
