- Boehringer Ingelheim (Ridgefield, CT)
- …benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Associate Director , US Product CMC Regulatory Affairs is responsible for the ... investigational and US market product portfolio. These responsibilities include management of CMC and product labeling changes...post marketing reports per US FDA regulations. The Associate Director , US Product CMC Regulatory Affairs acts… more
- Taiho Oncology (Pleasanton, CA)
- Director , Regulatory Affairs CMC Pleasanton, CA, USA Req #355 Tuesday, March 26, 2024 Looking for a chance to make a meaningful difference in the oncology space? ... Proposition: Join our dynamic and expanding mid-size oncology company in the role of Director , Regulatory CMC , reporting directly to Executive Director ,… more
- Merck (Rahway, NJ)
- …while developing and expanding your career. The Chemistry, Manufacturing & Controls ( CMC ) Pre-approval Pharm Executive Director is accountable for managing a ... available to patients in markets as needed. The Executive Director of CMC Pre-approval Pharm holds responsibility...leader both internally and externally with broad expertise in CMC regulatory strategy and dossier management activities… more
- AbbVie (North Chicago, IL)
- …Regulatory, Operations , Quality, Preclinical Safety, and Commercial organizations. Apprises CMC and Stakeholder Management of strategies, plans and risks ... meetings, develops agendas, issues highlights, apprise risks and plans with CMC Management , conduct periodic reviews, to ensure that phase transition criteria… more
- BeiGene (San Mateo, CA)
- …enable the cell therapy development. Ideal candidate must be proficient in both CMC strategic planning, execution, and matrix team management . The successful ... and third parties. + Partnering and aligning with Discovery, Regulatory, Operations , Quality, and Clinical functions, and managing CMC -focused deliverables… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Description** ** Director , Cell Culture Process Development - Pre-Pivotal Biologics CMC Development - Foster City, CA** At Gilead, we're creating a healthier ... Join Gilead and help create possible, together. **Job Description** The Director , Cell Culture Process Development (Pre-Pivotal) will be responsible for leading… more
- UTMB Health (Conroe, TX)
- …harm and promote mental health evaluation and treatment. + In concert with the UTMB CMC Mental Health Administrative Director , advises the UTMB CMC Mental ... Assoc Dir Mental Hlth CMC **Conroe, Texas, United States** Executive - Correctional...of mental health service for UTMB Correctional Managed Care Operations . + Assists in the direction, coordination, evidence based… more
- Boehringer Ingelheim (Ridgefield, CT)
- …broad and in-depth understanding of and experience in analytical sciences, CMC development, cGMP, laboratory management , good documentation practice, and ... **Description** The EACD department develops new CMC paradigms for more effective and efficient NCE development and for advancement of NCE-like Alternative Medicinal… more
- Novo Nordisk (Boulder, CO)
- …overall first level of project guidance. Relationships Reports into Director , CMC Program Development. Essential Functions + Project Management + Lead ... About the Department The Boulder Site is home to the specialized technical operations / CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …manner that facilitates Health Authority reviews. - Supports company`s GMP Change Management Program. Evaluates CMC changes for portfolio biologics and ... areas centered around rare diseases and immune disorders. **Summary** The Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC … more
- Merck (West Point, PA)
- …and execution of these activities to meet project timelines and objectives. + CMC Liaison for Life Cycle Management (LCM) through external collaborations. + ... process development and manufacturing of vaccine drug substances (DS) as the Executive Director for External Development, based in West Point, PA. This position will… more
- Bristol Myers Squibb (Summit, NJ)
- …personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Executive Director , Analytical Strategy and Operations (ASO) reports to the ... analytical commercial readiness. + Leads technical writing, specifications, stability and sample management , which includes authoring and review of CMC sections… more
- Option Care Health (Dover, DE)
- …developing, and retaining a diverse workforce. **Job Description Summary:** The Regional Director , Operations is responsible for delivering safe, efficient and ... all operational aspects in multiple Option Care Health Care Management Centers ( CMC ) while meeting all corporate...nursing. Ensures error proofing for pick, pack and ship operations . + Partners with Regional Director , Sales… more
- Gilead Sciences, Inc. (Foster City, CA)
- …more than 35 countries worldwide, with headquarters in Foster City, California. ** Director , Strategic Sourcing and Supplier Management , Biologics DP** **KEY ... RESPONSIBILITIES** The Director , Strategic Sourcing & Supplier Management , Biologics DP owns the strategic business relationship with multiple contract… more
- MTA (New York, NY)
- …Description POSTING NO. 6952 JOB TITLE: Assistant Director - C rew Management DEPT/DIV: Operations /Transportation WORK LOCATION: 89 E 42nd St, New York, NY ... Assistant Director - Crew management Job ID:...consistently practiced. + Provide supervision and guidance to the CMC workforce and support CMC management… more
- BeiGene (San Mateo, CA)
- …**Education Required:** Bachelor or Master Degree in Science or Business Administration, Operations Management , or similar education required, Supply Chain ... **General** **Description:** The Senior Director of CMO and Distribution Logistics, Clinical Supply...to collaborate and build strategic relationships with internal (Clinical Operations , Quality, CMC , Regulatory, etc.) stakeholders. +… more
- Editas Medicine (Cambridge, MA)
- …for both internal and external partners, oversee GMP and non-GMP material management , long range production planning at all current and future production locations, ... materials at all locations. Key Responsibilities: As the Sr. Director , Supply Chain, you will be responsible for: +...report to the VP of Supply Chain and Technical Operations and partner with leadership in TechOps, ClinOps, Finance,… more
- Teva Pharmaceuticals (West Chester, PA)
- …opportunity** Director is responsible for the development, execution and management of several clinical programs worldwide across all phases of clinical ... to be able to function independently in the daily management of clinical research projects including the preparation/review of...CMC , and pre-clinical development in this regard. The Director will be a key contributor to and responsible… more
- Merck (North Wales, PA)
- …to progress the R&D pipeline and realize its full potential. The Associate Director is expected to provide project management leadership and drive ... **Job Description** Global Project and Alliance Management (GPAM) sits in the Research & Division...(PMO), and Administrative Professionals. **Position Description/Summary:** The GPAM Associate Director , Project Manager, is a core member of Early… more
- Gilead Sciences, Inc. (Foster City, CA)
- …35 countries worldwide, with headquarters in Foster City, California. **Associate Director , Strategic Sourcing and Supplier Management , Primary Packaging ... RESPONSIBILITIES** The Associate Director , Strategic Sourcing & Supplier Management , Primary Packaging owns the business relationships with direct material… more