- Insmed Incorporated (NJ)
- …Are you?About the Role:This position is a key role that will provide regulatory CMC (RA CMC ) leadership and strategy to achieve regulatory approvals in various ... countries. As a strategic function, RA CMC is required to collaborate closely with multiple functions...regulatory strategies and identify the gaps and challenges of CMC development to ensure the approvability of the drug… more
- Insmed Incorporated (NJ)
- …of science, we're in. Are you?About the Role:The Associate Director, Regulatory Affairs, CMC will be responsible for reviewing the CMC post approval changes, ... providing regulatory impact assessments, and coordinating with regional RA- CMC leaders to formulate regulatory strategies for post-approval changes. This role will… more
- Insmed Incorporated (NJ)
- …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, and combination ... of deviations, CAPAs, change controls, and protocols/reports.Collaborate cross-functionally with CMC team, Regulatory, Clinical Operations, and Program Management to… more
- Organon & Co. (Plymouth Meeting, PA)
- …**The Position?** Reporting to the Director in Organon Regulatory CMC ,?the Associate Principal Scientist is responsible for?developing and?implementing Regulatory ... Chemistry, Manufacturing & Controls ( CMC ) strategies for?assigned?small molecule products in accordance with global regulations and?guidance, and?Organon… more
- Parexel (Columbia, SC)
- …highly motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs Senior/Consultant. This role is critical to ensure our client's ... timely approvals and supporting continued market access. Key Responsibilities Strategic CMC Leadership - Provide regulatory strategy input for small molecules… more
- Organon & Co. (Plymouth Meeting, PA)
- …or Executive Director in Organon Regulatory Chemistry, Manufacturing and Controls ( CMC ), the Associate Principal Scientist is responsible for developing and ... implementing Regulatory Chemistry, Manufacturing & Controls ( CMC ) strategies for assigned small molecule or biological products in accordance with global regulations… 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
- Merck & Co. (Rahway, NJ)
- …process comparability reports, Process performance qualification, and/or regulatory submissions. CMC RA : Experience supporting/writing regulatory filings (IND, MAA, ... agencies (FDA, EMA, JNDA, TGA).- Leadership: -Establish, manage and support Cell Culture CMC teams, and align resources to deliver on priorities. Manage and mentor a… 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. This role ... experience in the Pharmaceutical, Biotechnology or other Healthcare related field, direct CMC experience is highly desirable Ability to foster collaboration and work… 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)
- …process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients ... packaging activities as well as supply chain documentation to support critical CMC activities. Support the collection of clinical supply chain metrics and/or… more
- Merck & Co. (Rahway, NJ)
- …process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients ... packaging activities as well as supply chain documentation to support critical CMC activities. Responsible for authoring the Clinical Supplies section of the study… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …analyses, data science, machine learning, predictive modeling methodsindustrial biologics CMC development or manufacturing experience, CAR-T experience is highly ... and comparabilityIndustry leading knowledge in technology transfer, process comparability, CMC regulatory guidelines and manufacturing in cell therapyAbility to… more
- Insmed Incorporated (San Diego, CA)
- …senior leadership, as neededCollaborate with Clinical Development, Clinical Operations, CMC , QA/QC, Nonclinical, Program Management, and external consultants to ... diseasesPrior experience serving as the regulatory lead on cross functional teams ( CMC , clinical and project teams)Ability and experience in the development and… more
- Organon & Co. (Plymouth Meeting, PA)
- …affairs, safety and pharmacovigilance, Chemistry, Manufacturing and Controls ( CMC ), medical affairs and business development. Non-Clinical Safety Assessment ... + Author or review the non-clinical, early clinical development or CMC documentation to support regulatory submissions to regional Health Authorities worldwide;… more
- Merck & Co. (Rahway, NJ)
- …Commercial Manufacturing groups. The candidate should be capable of leading a cross-functional CMC team and is expected to be adept in managing work with external ... partners for timely execution of work.The successful candidate is expected to collaborate in a fast-paced, multidisciplinary, and highly matrixed team environment. The candidate is expected to be experienced in mammalian cell culture or purification process… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …negotiate contracts.Lead cross-functional teams and collaborate with Quality, Legal, CMC , MSAT, Manufacturing, Supply Chain, and Regulatory to prepare ... alternate/secondary sourcing strategies.Achieve cost savings objectives for product competitiveness.Support CMO contract negotiations in conjunction with alliance management.Ensure target inventory levels are maintained and reported monthly.Build and nurture… more
- ACROBiosystems Inc. (San Jose, CA)
- …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
- Merck & Co. (Rahway, NJ)
- …process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients ... & ensuring stable supply of product. - Primary activities include, but are not limited to: - Participates on the Clinical Trial Team (CTT) and collaborates closely with other functional area representatives to negotiate timelines and strategy for clinical… more
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