- 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
- Merck & Co. (North Wales, PA)
- …responsible for developing and implementing Chemistry, Manufacturing, and Controls ( CMC ) regulatory strategies for our organization's biologics product franchises in ... responsible for the leading the preparation and submission of CMC sections for commercial or new biologics products. The...include but are not limited to:Serve as a Regulatory CMC Project Lead and provide CMC Regulatory… more
- Novo Nordisk Inc. (Boulder, CO)
- …the Department The Boulder Site is home to the specialized technical operations/ CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the ... laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory, Technical Operations and RNAi Early… more
- Spectraforce Technologies Inc (Bridgewater, NJ)
- Job title: CMC Regulatory Technical Writer II Location: Bridgewater, NJ, Hybrid Duration: 1 year SHIFT SCHEDULE 1st shift, 9-5 EST Mon-Fri Pay Rate starts: $47/ HOUR ... Microsoft Office (Word, Excel, PowerPoint) VEEVA experience is a plus Description: The CMC Regulatory Technical Writer II authors high quality Module 2 and 3… more
- BioAgilytix (Durham, NC)
- …He or she is responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success and meets ... business needs.Essential ResponsibilitiesAssist in computer validations and equipment qualificationsEnsure all activities related to applicable computer systems and equipment qualifications follow national/international GxPs as well as data integrity, 21 CFR… more
- Sunrise Systems Inc (New Brunswick, NJ)
- …with 5+ years in the pharmaceutical industry, preferably with 3+ years CMC regulatory experience Skills/Knowledge Required: Experience with CMC regulatory ... and supplements/variations) Knowledge of FDA, EMA and/or ICH guidelines and CMC regulations Experience in post-approval requirements Experience in developing CMC… more
- Atrium Health (Charlotte, NC)
- …well and visit our careers page: Atrium Health's 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...physicians and providers specializing in all areas of medicine. CMC serves as the region's only Level 1 trauma… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Associate Director, RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio small ... for working on cross-functional teams, developing and executing post-approval Regulatory CMC strategies, reviewing CMC information and data, authoring … 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
- Option Care Health (Columbus, OH)
- …and resolving problems.Go-to for troubleshooting issues and resolutions with CMC Patient Registration team members.Maintains updated knowledge of industry, ... regulatory and reimbursement issues and of payer requirements. Keeps AVA team abreast of key changes.Assists with roll out of new policies and procedures. Supervisory ResponsibilitiesDoes this position have supervisory responsibilities? YES(ie hiring,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and Oncology, incl. coordinating Reg Intelligence & Policy activities with the Regulatory- CMC function and corporate affairs as needed. In the short term, the ... with DS' strategic objectivesWork with other DS functions (incl. Regulatory- CMC ) to coordinate Regulatory Intelligence activities and ensure regulatory/development… more
- Novo Nordisk Inc. (Boulder, CO)
- …the Department The Boulder Site is home to the specialized technical operations/ CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the ... laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory, Technical Operations and RNAi Early… more
- Novo Nordisk Inc. (Boulder, CO)
- …the Department The Boulder Site is home to the specialized technical operations/ CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the ... laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory, Technical Operations and RNAi Early… more
- Novo Nordisk Inc. (Boulder, CO)
- …the Department The Boulder Site is home to the specialized technical operations/ CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the ... laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory, Technical Operations and RNAi Early… more
- Integrated Resources, Inc (Atlanta, GA)
- …. Request additional resources as necessary. . Maintains positive working relationships within CMC auditing team and client areas. . Share and apply lessons learned. ... (Specifications, Methods, etc.) . Prioritize audit sections based on CMC request. . Effectively listen to the auditee and...related to the use of electronic audit tools. . Support Process Improvement initiatives for CMC client and auditing… more
- Novo Nordisk Inc. (Boulder, CO)
- …the Department The Boulder Site is home to the specialized technical operations/ CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the ... laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory, Technical Operations and RNAi Early… more
- Novo Nordisk Inc. (Boulder, CO)
- …the Department The Boulder Site is home to the specialized technical operations/ CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the ... laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory, Technical Operations and RNAi Early… more
- Merck & Co. (Rahway, NJ)
- …a history of peer-reviewed publications and presentationsKnowledge of biologics CMC developmentAdaptability and agility to prioritize and deliver complex objectives, ... utilizationExcellent interpersonal and communication skillsPreferred Experience and Skills:Leadership of CMC development teamsContinuous biomanufacturing and high-throughput microbioreactors integrated with… more
- Insmed Incorporated (Bridgewater, NJ)
- …with subject matter experts in discovery, bioanalysis, pharmacokinetics, clinical development, CMC , and program management to drive the overall development strategy ... toxicology issue resolution.Provide impurity safety assessment in support of CMC manufacturing and/or registration.Contribute to department SOPs and best practice… more
- Novo Nordisk Inc. (Boulder, CO)
- …the Department The Boulder Site is home to the specialized technical operations/ CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the ... laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory, Technical Operations and RNAi Early… more
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