- Insmed Incorporated (NJ)
- …are seeking a highly experienced and visionary Vice President, Product Development - CMC , Small Molecules, to help us expand what's possible for patients with ... SVP, Technical Operations, you will lead all Chemistry, Manufacturing, and Controls ( CMC ) activities for the company's small molecule pipeline. As a senior leader,… more
- Merck & Co. (Rahway, NJ)
- …project management activities to ensure efficient execution and compliance within CMC operations. The responsibilities of the dCMC Business Analyst include:- ... Business Process Mapping and Optimization: Working with Digital CMC and associated business stakeholders, the analyst will map end-to-end processes that produce… more
- Merck & Co. (Rahway, NJ)
- …(DCT) leader is-accountable for delivering a fully integrated stage-appropriate CMC development and commercialization strategy which yields the target commercial ... options analysis and provides recommendation to governance for endorsement.Represent CMC and effectively communicates across the governance bodies, stakeholders and… more
- Insmed Incorporated (NJ)
- …are seeking a highly experienced and visionary Vice President, Product Development - CMC , Gene Therapy and Large Molecules, to help us expand what's possible for ... therapies to patients.What You'll Do: As the Vice President, Product Development - CMC , Gene Therapy and Large Molecules, you will define and execute the product… more
- Larimar Therapeutics (Philadelphia, PA)
- …expertise in discovery, non-clinical and clinical development, regulatory affairs, manufacturing and CMC . Our company's strategy is to become a leader in the ... the day - we welcome you! Position Summary: Larimar is seeking a CMC Regulatory Affairs Director to provide professional experience and leadership supporting the… more
- Unknown (Boston, MA)
- …will collaborate cross-functionally with internal teams to ensure alignment of CMC regulatory strategies with overall development plans and corporate objectives. ... providing expertise and guidance to the client contact for CMC development teams. The Director will also lead regulatory...monitoring changes in regulations and guidelines that may impact CMC development programs. The ideal candidate will have a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …2026. This full-time position works for approximately 37.5 hours per week.Responsibilities:As CMC Technology Management, we support every step of CMC strategy, ... the department and provide beneficial experience and understanding of CMC principles, strategies, and processes: Understand regulatory compliance/requirements of… more
- Formation Bio (New York, NY)
- …where you will work closely with our business development, legal, clinical, CMC , and data/engineering teams to on-board products with strong IP potential, and ... Comfortable working cross functionally, including partnering with clinical and CMC teams to identify patentable innovations during development, collaborating with… more
- Formation Bio (New York, NY)
- …NDAs/BLAs and other relevant regulatory filings. Provides Regulatory CMC guidance around drug development and manufacturing/supply processes Understands, ... development, registration and manufacturing of biopharmaceutical products in support of CMC applications Serves as corporate liaison with regulatory Health Authority… more
- Formation Bio (New York, NY)
- …to join our dynamic team. This critical role will report to the VP, CMC and will be responsible for leading formulation development and manufacture for all drug ... of formulations for injection. Cross-Functional Collaboration: Partner with other CMC groups (analytical development, supply chain, etc) quality assurance,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …This effort will extend to participation in a variety of cross functional CMC and quality forums under the Joint Manufacturing Committee in the commercial governance ... and comparability protocols and reportsServe as reviewer/author of a variety CMC sections or regulatory submissions, risk assessments, validation impact assessments,… more
- Merck & Co. (Rahway, NJ)
- …in-silico design / modeling.Familiarity with drug development cycle, especially the CMC (Chemistry, Manufacturing, and Control) aspect, with skills to help advance ... our digital effort in this area.Familiarity with biocatalysis, protein engineering, biotherapeutics, and / or vaccines is advantageous.Knowledge and experience in downstream process development, such as flocculation, microfiltration, ultrafiltration,… more
- Insmed Incorporated (NJ)
- …as a point of contact for cross-functional teams (eg, Clinical, Nonclinical, CMC ) to ensure effective coordination and execution of regulatory deliverables Monitor ... new regulations and guidelines to ensure internal processes and deliverables remain compliant Contribute to the development and improvement of regulatory systems, tools, and procedures to enhance efficiency and quality Maintain submissions and correspondence… more
- Merck & Co. (Rahway, NJ)
- …state-of-the-art facility, that is a key part of our Chemistry, Manufacturing, and Controls ( CMC ) hub at our site headquarters in Rahway, NJ. This facility will be ... fully online in the next few years, both in terms of facility construction and organizational realization. The GMP facility is designed for multi-product operations with flexible operating suites, which can adjust as the clinical pipeline demands change. It is… more
- Merck & Co. (Rahway, NJ)
- …state-of-the-art facility, that is a key part of our Chemistry, Manufacturing, and Controls ( CMC ) hub at our site headquarters in Rahway, NJ. This facility will be ... fully online in the next few years, both in terms of facility construction and organizational realization. The GMP facility is designed for multi-product operations with flexible operating suites, which can adjust as the clinical pipeline demands change. It is… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …GMP relevant activities involving but not limited to supplier qualification program, CMC audit, clinical/IMP vendor audits and overall GMP vendor audit program. ... Establish lessons learned from audits/inspections to drive continuous improvement in collaboration with other QA functions and/or applicable stakeholders. Support/ lead and or co lead due- diligence assessments of GMP facilities and or CMOs as deemed… more
- Formation Bio (New York, NY)
- …initial evaluation to pre-close. Coordinate cross-functional workstreams (Clinical, CMC , Regulatory, Nonclinical, QA, Commercial, Finance, Legal/IP). Maintain ... trackers, RAID logs, and timelines; deliver leadership updates and red-flag summaries. Orchestrate expert calls, debriefs, and management meetings, capturing insights and follow-ups. Confirmatory Diligence Leadership Drive scientific, technical, and commercial… more
- Insmed Incorporated (NJ)
- …and regulatory archives.Partner with cross-functional teams (Regulatory Affairs, CMC , Clinical, Quality) to facilitate document authoring, review, approval, ... and publishing workflows.Conduct technical checks (validation, bookmarking, hyperlinking) to ensure submissions pass regulatory agency gateways.Support lifecycle management of submissions, including post-approval supplements, variations, and periodic… more
- ACROBiosystems Inc. (Boston, MA)
- …target discovery and validation, candidate drug screening and optimization, CMC development, preclinical and clinical studies, commercial production, and companion ... diagnostics. We are committed to excellence in providing quality products and services and accelerating the process of therapeutic development. Our mission is to accelerate the process of target therapeutic drug development. We aim to be a cornerstone company… more
- Aequor (Thousand Oaks, CA)
- …job responsibilities. is searching for a Sr. Project Manager in our CMC Integration team within Operation Products Advancement in Process Development. The Sr. ... Project Manager (PM) will be responsible for supporting cross functional initiatives that require both tactical workstream management and support for overarching project governance. This role requires a foundational knowledge of resource management and the… more
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