- Aequor (Seattle, WA)
- …etc. Strong knowledge of biopharma industry. Familiarity/experience with end-to-end CMC analytical method development & transfer. Job DescriptionThe Technical ... Supply Chain, etc. Develop and communicate status to organizational leadership. CMC Support and Sub-Team Management Responsibilities: Lead and coordinate Analytical … more
- Aequor (Thousand Oaks, CA)
- …description and be able to speak to why they want to work in regulatory affairs/ CMC . This was a big miss on the last posting. Pre screening responses from job ... description, what do you understand this role to be?The Associate Regulatory Affairs ( CMC ) role is an entry level regulatory position that provides varying levels of… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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
- BioAgilytix (Durham, NC)
- …- Education/ExperienceBachelor's degree in laboratory-based sciences, including chemistry, pharmaceutical science, molecular biology, chemistry, biochemistry, ... immunology, biotechnology, or related field with more than two (2) years' experience in a scientific laboratory environmentMaster's degree in laboratory-based sciences, including chemistry, pharmaceutical science, molecular biology, chemistry, biochemistry,… more
- Atrium Health (Charlotte, NC)
- …The RN Clinical Nurse I provides professional nursing care through skillful assessment, diagnosis, outcomes identification, planning, implementation, and evaluation ... in accordance with facility or department policies procedures, and/or protocols under the supervision of the nursing leader. Assists in maintaining a safe work environment and performs all related job responsibilities in a safe manner. Maintains clinical and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(mAb, Drug Substance, Drug Product, or New Modality) manufacturing, evaluates CMC risks for appropriate escalation, recommends transition milestones and ensures a ... manufacturing plans at the site which are aligned with cross-functional CMC strategic discussions. Manage timelines, deliverables, and coordinate the input of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disorders.Summary The Associate Director, RACMC, is responsible for the regulatory CMC (Chemistry, Manufacturing and Controls) activities from early development to ... G-RACMC lead or regional submission lead. Provide regulatory guidance and strategy to CMC sub-team and G-RA teams along with other functional teams leading to sound… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …science, or related field Minimum 8+ years of industrial biologics CMC development or manufacturing experience, CAR-T experience is highly desirable. Extensive ... in Cell Therapy tech transfer and/or MSAT. Experience in a cross functional CMC team as a technical representative driving global programs. Experience as a technical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Development, Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams. Will be interfacing with both ... Development, Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams to deliver and drive the… more
- Lundbeck (Bothell, WA)
- …Process Development Center of Excellence for Biologics within the global Lundbeck CMC organization. Since integrating into Lundbeck in October 2019, Lu-SBP has ... represent the Potency team as needed Assist in the preparation of CMC regulatory submissions including authoring and/or review REQUIRED EDUCATION, EXPERIENCE and… more
- Atrium Health (Charlotte, NC)
- …well and visit our careers page: Atrium Healths Carolinas Medical Center ( CMC )is the flagship hospital of Atrium Health, distinguished throughout the Southeast for ... and medical expertise. From its modest beginnings in 1943, CMC evolved into the largest hospital in the region...1,100 physicians and providers specializing in all areas of medicine. CMC serves as the regions only Level 1 trauma… more
- Catalent (St. Petersburg, FL)
- …to provide not only research and testing of products, but also support CMC development activities in support of client regulatory filings.Catalent is committed to a ... Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.The RoleAnalysis of finished products, in-process materials, fill moisture, raw materials, and cleaning verification and… more
- Merck & Co. (Rahway, NJ)
- …areas of Analytical Research and Development, Biologics Process Research and Development, CMC and Regulatory in aspects of control strategy and filings, Quality and ... our partners in the commercialization and manufacturing is essential.The successful candidate must function well and be able to collaborate in a fast-paced, integrated, multidisciplinary team environment. Research and industry experience should demonstrate… more
- Merck & Co. (North Wales, PA)
- …input from diverse disciplines (eg, clinical, regulatory, market access, manufacturing, CMC , commercial, and other areas) as applicable to the project.Building and ... maintaining project schedules and critical project information in enterprise project management systems and databases. Using these tools to integrate activities across key team members, proactively identify risks, and ensure clear and effective communication… more
- Merck & Co. (Rahway, NJ)
- …with other analytical groups in ARD , Global Quality and Regulatory Affairs- CMC to ensure that validated methods are appropriately transferred from our Research ... & Development Division space our Manufacturing Division testing sites. --Job Responsibilities:Develop microbiological method validation protocols/reports, method transfer protocols/reportsSupport follow up studies post transfer activities (RY or WP as… more
- Aequor (Thousand Oaks, CA)
- …just lab but manufacturing and process development. This manager position within CMC will facilitate product development and global registration by developing and ... executing regulatory strategies and effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. Title: Regulatory Project Coordinator (RPC)Job Description: o Assist Regional Regulatory Representative to… more
- Aequor (Thousand Oaks, CA)
- …molecule development and commercial lifecycle maintenance, product stability programs, CMC regulatory filings, risk assessment, and Quality Management Systems. ... offers the opportunity to be at the interface between research, global development and manufacturing to ensure that our molecules become medicines. Many of the technologies were employing are not only new to but are new to the industry as a whole. Help us to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …across Regulatory Affairs, as well as cross-functional stakeholders (eg, RA CMC , R&D Excellence, Clinical Operations, IT).Responsibilities Operate within and in ... support of the established RD data governance frameworkPartner with RD Excellence to support ongoing process improvement related to data governance to ensure data integrity, quality, consistency, and compliance with regulatory requirements.Define data… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …science, or related field. Minimum 8+ years of industrial biologics CMC development or manufacturing experience, CAR-T experience is highly desirable. Extensive ... experience in cell therapy commercial cGMP operations with end-to-end know-how to drive changes/improvements and capacity plans in a global manufacturing network. Candidate must have extensive experience in Cell Therapy tech transfer and/or MSAT. Experience in… more
- Gilead Sciences, Inc. (Foster City, CA)
- …countries worldwide, with headquarters in Foster City, California. **Sr Director, CMC Regulatory Affairs -Small Molecules** **KEY RESPONSIBILITIES** The Sr Director, ... CMC Regulatory Affairs for Small Molecules is responsible for...with Gilead's global portfolio of small molecule products in CMC Regulatory Affairs. This position will lead a global… more
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