- 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
- 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
- Merck & Co. (Rahway, NJ)
- …of regulatory submissions. -Under the general scientific and administrative direction of Director in the CCFS group and working in conjunction with internal and ... communication skills Preferred Experience and Skills Experience in leadership of CMC development teams.Experience with cell culture process development for both… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …integrity, and timelines for assigned studies and escalates issues to the Associate Director of Medical Coding to gain resolution. Functional Expertise:Study ... conventions. Reviews and submits DS Medical Coding synonym list update requests to the Associate Director of Medical Coding to ensure accuracy and consistency of… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as the Associate Director , CMC Program Lead in Allogeneic Cell Therapies. You ... will be responsible to collaborate across Cell Therapy CMC functions and RA functions to deliver CMC pipeline and CMC platform projects. You will sit within… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Join Gilead and help create possible, together. **Job Description** We are seeking an Associate Director , Regulatory Affairs CMC candidate to sit at our ... Foster City, CA site. **Responsibilities:** + The CMC Regulatory Affairs Associate Director at Gilead is responsible for providing strategic direction,… more
- AbbVie (North Chicago, IL)
- …for preparation, review and approval of these Chemistry, Manufacturing, and Controls ( CMC ) sections of submission documents. Plays a critical role in ensuring that ... the CMC submission strategy is aligned closely with the clinical/regulatory...drug development experience and advice as appropriate to the CMC team. Responsibilities List up to 10 main responsibilities… 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
- WuXi AppTec (Boston, MA)
- …drug). We greatly simplify the TIDES drug development by providing all discovery, CMC development, and the entire manufacturing supply chain under one roof. **Please ... of relevant pharmaceutical or biotech industry experience in discovery chemistry, CMC process development and/or GMP manufacturing. + Working knowledge and… more
- AbbVie (Waltham, MA)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description As an Associate Director of Regulatory Affairs in Chemistry, Manufacturing, and ... Controls ( CMC ), you will collaborate with both internal and external...& gene therapies. You will be responsible for creating CMC regulatory strategies that facilitate first-pass approvals of regulatory… more
- Gilead Sciences, Inc. (Foster City, CA)
- …aspirations. Join Gilead and help create possible, together. **Job Description** ** Associate Director , Analytical Regulatory Sciences, Systems & Operations in ... is a site based position located in Foster City, CA_** The Associate Director , Analytical Regulatory Science, collaborates with product development,… more
- ThermoFisher Scientific (Providence, RI)
- …pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits. Reporting to the Associate Director , CMC QC Stability, will be ... responsible for managing routine operations of the cell banks, critical intermediates, Drug Substance and Drug Product for clinical GMP stability programs of cell and genetic therapies while ensuring compliance with SOPs, internal policies and industry… more
- UTMB Health (Dickinson, TX)
- Mental Health Clinician - CMC - Carole Young **Dickinson, Texas, United States** Social Service UTMB Health Requisition # 2404113 The mission of Correctional Managed ... Works under the supervision of a Psychologist, Mental Health Manager and/or Program Director . **_ESSENTIAL JOB FUNCTIONS_** **:** + Contributes to the success of the… more
- AbbVie (North Chicago, IL)
- …on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description As an Associate Director , Operations Strategy and Pipeline Leadership (OSPL) within the ... Microsoft Office, and protected document vaults. + Serve as the PDS&T CMC (Chemistry, Manufacturing, and Controls) lead for Corporate Licensing and Acquisition (L&A)… more
- Otsuka America Pharmaceutical Inc. (Rockville, MD)
- **Job Summary** Associate Director , Quality Control, Biologics is responsible for late development stage through commercial biologic products including product ... scientific disciplines to drive programs through critical milestones. Collaborate with CMC teams and demonstrating ability to understand and communicate impact of… more
- Vera Therapeutics (Brisbane, CA)
- Title: Associate Director , Project Management Location: Brisbane, California About Us: Vera Therapeutics (Nasdaq: VERA), is a late clinical-stage biotechnology ... immunological diseases. Position Summary We are seeking a highly skilled and motivated Associate Director , Project Management. The ideal candidate will work with… more
- Sanofi Group (Cambridge, MA)
- **Job Title** : Associate Director , Drug Substance Commercial Development **Location:** Cambridge, MA **About the Job** Are you ready to shape the future of ... progress. The Commercial Process Development team, part of the CMC Synthetics Platform within the Sanofi R&D organization, is...join our growing Commercial Process Development team as an Associate Director . Under the direction of the… more
- Lilly (Indianapolis, IN)
- …of the scorecards with the 3rd parties. The key responsibilities for a business/operations Associate Director or Director may include: + Works with BRD, ... from vendors by effective communication between vendor, finance and CMC PM teams. + Manage the collection of performance...early or late phase and basic technical understanding of CMC functions and roles. + Strong interpersonal and teambuilding… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- We are seeking an ** Associate Director ** within the Formulation Development Group of Regeneron Pharmaceutical Inc. at Tarrytown, NY. This role will lead clinical ... functions and stakeholders including Therapeutic Focus Areas, Pre-clinical Development, CMC and Manufacturing (DS and DP), Program Management, Regulatory, Quality,… more
- WuXi AppTec (Cranbury, NJ)
- **Overview** ** Associate Director , Project Management (Oligo and Peptide)** **Area of focus: Discovery or medicinal chemistry** **Job Location: Remote USA with ... simplify the TIDES drug development by providing all discovery, CMC development and the entire manufacturing supply chain under...+ Work closely with team members across all Discovery, CMC related business units and with the WuXi-TIDES management… more
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