- Insmed Incorporated (NJ)
- …each other, and for the future of science, we're in. Are you?About the Role:The Sr. Director CMC QA will lead QA CMC oversight for drug products, biologics, ... phase-appropriate GMP compliance across manufacturing development, while providing strategic Quality leadership across internal teams and external partners. The… more
- Merck & Co. (Rahway, NJ)
- …talented and dedicated colleagues while developing and expanding your career.The Executive Director , Chemistry, Manufacturing & Controls ( CMC ) , Pre-approval ... a team of CMC professionals, ensuring rigorous CMC regulatory strategy and delivery of high- quality ...conjugates (ADCs), and traditional solid-oral small molecules.- The Executive Director will help drive our company's growth into new… more
- Insmed Incorporated (NJ)
- …and for the future of science, we're in. Are you?About the Role:The Associate Director , Regulatory Affairs, CMC will be responsible for reviewing the CMC ... changes, providing regulatory impact assessments, and coordinating with regional RA- CMC leaders to formulate regulatory strategies for post-approval changes. This… more
- Insmed Incorporated (NJ)
- …and for the future of science, we're in. Are you?About the Role:The Associate Director , Quality Control will be responsible for leading and overseeing all ... Quality Control activities related to inhalation products, including both Active Pharmaceutical Ingredients (API) and Drug Product. This role will manage external QC… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Director , Engineering, Packaging Commercialization will lead packaging development for new products including parenteral products ... involves collaborating with stakeholders across the end-to-end continuum of CMC areas and requires both an understanding of packaging...new products on cross-functional teams. - - The Associate Director will be accountable for the d efinition and… more
- Merck & Co. (Rahway, NJ)
- …As a result, VCM Product Leaders have direct impact on cost, quality , customer service, and compliance which ultimately affects access, continuity of supply, ... product enhancements, cross-product considerations, process and method technical changes, robustness/ quality / productivity projects. Manage product supply risk through Integrated… more
- Insmed Incorporated (San Diego, CA)
- …and for the future of science, we're in. Are you?About the Role:The Director , Regulatory Affairs will serve as the regulatory leader on cross-functional teams, where ... senior leadership, as neededCollaborate with Clinical Development, Clinical Operations, CMC , QA/QC, Nonclinical, Program Management, and external consultants to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Director of Manufacturing Execution System as part of the Global MSAT team based ... in Raritan, NJ. Role OverviewThe Director of Manufacturing Execution System (MES) will be part...will work collaboratively with Operations, IT QA, Validation, Reg CMC to deliver on-time, on-budget and right-first-time MES solutions… more
- Kelly Services (South San Francisco, CA)
- Kelly(R) Science & Clinical is seeking an Associate Director of CMC Project Management for a one-year contract opportunity with a leading biopharmaceutical ... Hybrid, onsite in South San Francisco, CA **Position Title:** Associate Director , CMC Project Management **Position Type:** One-year contract **Pay… more
- Merck (Rahway, NJ)
- …and dedicated colleagues while developing and expanding your career. The Executive Director , Chemistry, Manufacturing & Controls ( CMC ), Pre-approval Pharm will ... a team of CMC professionals, ensuring rigorous CMC regulatory strategy and delivery of high- quality ...conjugates (ADCs), and traditional solid-oral small molecules. The Executive Director will help drive our company's growth into new… more
- Lilly (Philadelphia, PA)
- …and advance care for patients with unmet needs. **Position Overview:** The Associate Director , CMC Development will be responsible for the execution of multiple ... radiopharmaceutical CMC development and manufacturing programs supporting various therapeutic areas within Lilly Avid. In this capacity, this role will drive the… more
- Boehringer Ingelheim (Athens, GA)
- …in close collaboration with Quality , R&D and Operations/Manufacturing. The Director , Scientific Expert CMC provides subject matter expertise in functional ... reflect Boehringer Ingelheim's high regard for our employees. The Director , Scientific Expert CMC is responsible for...goals. + Defines, plans, and oversees the development of high- quality CMC regulatory submissions, with a focus… more
- Lilly (Indianapolis, IN)
- …better for people around the world. Lilly is looking for post approval regulatory CMC scientists to join us in delivering life-changing new medicines to patients who ... need them all over the world. The Senior Advisor/ Director Post approval scientist in Global Regulatory Affairs -... Post approval scientist in Global Regulatory Affairs - CMC commercial solid oral products will use CMC… more
- Lilly (Indianapolis, IN)
- …support communities through philanthropy and volunteerism. **Position Summary:** The Senior Director , CMC Project Management will provide strategic and ... operational leadership for cross-functional CMC team(s) and will partner with CMC ...competitive plans, anticipate risks, effectively communicate risks, enable high quality decisions at fast speed and implement decisions. +… more
- Boehringer Ingelheim (Ridgefield, CT)
- …Ingelheim is currently seeking an Associate Director or Senior Associate Director to join our External Alternative CMC Development (EACD) department located ... for leading all DP-related activities within the project(s), in support of CMC development within EACD. The Associate Director /Senior Associate Director… more
- AbbVie (North Chicago, IL)
- …external third parties. The primary function is to ensure consistent preparation of CMC regulatory submission documents of high scientific and technical quality ... 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
- BeOne Medicines (San Mateo, CA)
- …be responsible for development of strategies, planning, drafting, and managing CMC -related regulatory submissions and HA interactions to meet the aggressive ... projects. The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on relevant topics. **Essential… more
- AbbVie (North Chicago, IL)
- …external third parties. The primary function is to ensure consistent preparation of CMC regulatory submission documents of high scientific and technical quality ... 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
- UTMB Health (Galveston, TX)
- Director of Operations, - CMC - Galveston County Jail **Galveston, Texas, United States** Business, Managerial & Finance UTMB Health Requisition # 2503778 The ... definition, and solution of systems problems through operations analysis and quality assessment. Reports to the Associate Vice President Outpatient Services,… more
- AbbVie (Boston, MA)
- …LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description Purpose: The Associate Director will be fully accountable for providing CMC leadership to ... required. + Significant technical understanding of biologics manufacturing as well as associated quality and analytical issues is required. + Ability to work in a… more