- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …manner that facilitates Health Authority reviews.- Supports company`s GMP Change Management Program . Evaluates CMC changes for portfolio biologics and determines ... areas centered around rare diseases and immune disorders.Summary The Associate Director, RACMC Portfolio Products, will be responsible for...filing strategies, provides expertise as regulatory CMC representative to project teams, and supports… more
- Novo Nordisk Inc. (Boulder, CO)
- … CMC , Regulatory, Quality, teams Strong organizational, planning, and project management skills, including ability to multitask and organize/track information ... the Department The Boulder Site is home to the specialized technical operations/ CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the… 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)
- …development, and/or engineering and regulatory science.Proven ability to lead program development teams using project management skills.Preferred Experience ... organizations (Research Division/Manufacturing Division), such as Analytical, Quality, Regulatory CMC , and technical functions, to ensure timebound progression of… more
- Merck & Co. (Rahway, NJ)
- …The FLEx Co-Lead role is based in New Jersey and reports to the Associate Vice President of Pharmaceutical Operations and Clinical Supply in our Research and ... range from quality and regulatory compliance, operational excellence, pipeline program support, financial, talent development and diversity/equity/inclusion.- Key to… more
- Lilly (Indianapolis, IN)
- …CMC and device team members, program teams and functional leads. + Provide CMC Project Management for both internal and external CMC development and ... people around the world. ** Associate Director** **; CMC , Device Development Program Manager** **Functional Area:...+ Create, maintain, and articulate for various audiences detailed CMC and device project plans to ensure… more
- Regeneron Pharmaceuticals (Troy, NY)
- …assembly of responses to inquiries from regulatory agencies on the content of CMC documents + Collaborates with project teams to support activities related ... for compliance with regulations. + Contributes to the development and execution of CMC regulatory strategies for programs + Identifies project issues and… more
- Frontier Medicines (Boston, MA)
- Join Frontier Medicines on an exciting journey as our newest Senior Manager/ Associate Director in CMC Development, located at either our Boston or South San ... of our team, reporting directly to the Head of CMC , you'll play an integral role in advancing our...substance process development and manufacturing + Coordinating drug substance program management + Engaging with CROs/CDMOs and identifying new… more
- Billings Clinic (Missoula, MT)
- …system(s) and business needs Minimum Qualifications Education * Graduate of an accredited program of nursing. Associate (or Diploma) RNs hired into this position ... Defined Contribution Pension Plan, Paid Time Off, employee wellness program , and much more.Click here (https://www.billingsclinic.com/careers/employee-benefits/) for more information… more
- UTMB Health (Richmond, TX)
- …or community programs. **_ESSENTIAL JOB FUNCTIONS_** **:** + Coordinates activities of specified project or program in support of project aims, goals, ... Coordinator I - CMC - Jester III **Richmond, Texas, United States**...duties, trains, and monitors progress of those assisting with project . + Interprets program and services to… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …that facilitates Health Authority reviews. - Supports company`s GMP Change Management Program . Evaluates CMC changes for portfolio biologics and determines ... centered around rare diseases and immune disorders. **Summary** The Associate Director, RACMC Portfolio Products, will be responsible for...filing strategies, provides expertise as regulatory CMC representative to project teams, and supports… more
- Merck (Boston, MA)
- …clinical development teams and the operational/executional arms within the business. The Program Clinical Supplies Project Manager ( Program CSPM) serves ... spokesperson at clinical and development related meetings. Working independently, the Program CSPM designs strategic and operational plans for all clinical supply… more
- Sumitomo Pharma (Columbus, OH)
- …management of the global contract testing laboratories in partnership with the Company's CMC Team. The Associate Director also participates in drafting and ... ** Associate Director, GMP Quality Control** Sumitomo Pharma America...date is available to support commercial product and clinical program needs. **Job Duties and Responsibilities** + Represent QC… more
- Emory Healthcare/Emory University (Atlanta, GA)
- …and events focused on career advising and preparation of graduate students across each program served by the Career Management Center ( CMC ). + Develops the ... community. **Description** The Goizueta Business School is in search of an Associate Director - Graduate Student Advising and Programming to join the Graduate… more
- Stantec (San Diego, CA)
- Project Engineer - Mechanical - ( 24000056 )...design. + Knowledge of applicable codes and standards, including CMC , CPC, CFC, CBC, NFPA, and ASHRAE, as well ... Join us and design your place with Stantec. **Your Opportunity** The Project Designer, Mechanical draws on strong buildings engineering skills and industry… more
- Stantec (Denver, CO)
- Project Designer - Mechanical - ( 230003Y7 )...preferred. + Knowledge of applicable codes and standards, including CMC , CPC, CFC, CBC, NFPA, and ASHRAE, as well ... Join us and design your place with Stantec. **Your Opportunity** The Project Designer, Mechanical draws on strong buildings engineering skills and industry… more
- Stantec (San Francisco, CA)
- Mechanical Engineer - Project Manager - ( 2400017O ) **Description** Stantec Buildings is on a mission to become the world's leading integrated design practice. Our ... base design approach, and industry experience to consistently produce project deliverables that meet project requirements, ...Strong knowledge of applicable codes and standards, including CBC, CMC , NFPA, and ASHRAE, as well as LEED, green… more
- Sanofi Group (Bridgewater, NJ)
- …methodologies as appropriate + Contributes to the development of Global Regulatory Project Strategy (GRPS) and ensures alignment with the core product labeling for ... strategy in collaboration with non-US - non-EU regions / GRA- CMC / GRA-Devices. Attends HA meetings and collaborates with...sub team to ensure NDA/BLA/ MAA/Extensions filings meet the project timelines for product launch and is responsible for… more
- Sanofi Group (Bridgewater, NJ)
- …methodologies as appropriate + Contributes to the development of Global Regulatory Project Strategy (GRPS) and ensures alignment with the core product labeling for ... strategy in collaboration with non-US - non-EU regions / GRA- CMC / GRA-Devices. Attends HA meetings and collaborates with...sub team to ensure NDA/BLA/ MAA/Extensions filings meet the project timelines for product launch and is responsible for… more
- Gilead Sciences, Inc. (Foster City, CA)
- …35 countries worldwide, with headquarters in Foster City, California. ** Associate Director, Strategic Sourcing and Supplier Management, Primary Packaging ... Components** **KEY RESPONSIBILITIES** The Associate Director, Strategic Sourcing & Supplier Management, Primary Packaging...Cork, Ireland) and is eligible for the Gilead GFlex program allowing remote work up to 2 days per… more
