- 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
- 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
- Regeneron Pharmaceuticals (Troy, NY)
- …a typical day might include the following + Provides oversight on the IOPS CMC intelligence program + Collaborates with the Regulatory Intelligence and GMP ... The Director of CMC Industry and Regulatory Intelligence is responsible for...Strong communication skills, both oral and written. + Strong project management leadership skills essential + Good understanding of… more
- Boehringer Ingelheim (Ridgefield, CT)
- **Description** The EACD department develops new CMC paradigms for more effective and efficient NCE development and for advancement of NCE-like Alternative Medicinal ... Therapeutic Product (ATMP) projects. The Associate Director, Analytical/QC will be responsible for leading activities related to Analytical Development/Quality… 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
- 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
- Teva Pharmaceuticals (Parsippany, NJ)
- Business Optimization Leader ( Associate Director, Project Mgmt) Date: Mar 7, 2024 Location: Parsippany, United States, New Jersey, 07005 Company: Teva ... internal and external functions such as clinical development, medical affairs, CMC , global regulatory affairs, TGO, sourcing and commercial to seamlessly integrate… more
- Merck (West Point, PA)
- …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
- Lilly (IN)
- …to make life better for people around the world. **Position Summary:** The Associate Director, Clinical Supply Management has responsibility for the end to end ... delivery of clinical supplies across the oncology portfolio. + Communicate with CMC and clinical partners to outline potential risks, limitations, and mitigation… 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
- Gilead Sciences, Inc. (Foster City, CA)
- …35 countries worldwide, with headquarters in Foster City, California. ** Associate Director, Strategic Sourcing and Supplier Management, Commercial Packaging** **KEY ... RESPONSIBILITIES** The Associate Director, Strategic Sourcing & Supplier Management, Commercial Packaging...Gilead site and is eligible for the Gilead GFlex program allowing remote work up to 2 days per… 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
- 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
- ThermoFisher Scientific (St. Louis, MO)
- …biological molecule dossiers and provide strategic regulatory support for site project teams in partnership with Global Regulatory Affairs. **Responsibilities** + ... Authoring, reviewing, and commenting for Chemistry Manufacturing and Control ( CMC ) CTD documents for biologics products, including Investigational Applications (IND,… 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
- 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
- AbbVie (South San Francisco, CA)
- …YouTube and LinkedIn. Job Description We are currently seeking a Regulatory Affairs Associate Director to join our growing regulatory team. In this role you would ... guidance and execution of regulatory concepts within cross - functional project teams and supports interactions with global health authorities and corporate… more
- University of Southern California (Los Angeles, CA)
- … Associate Director Process DevelopmentApply (https://usc.wd5.myworkdayjobs.com/ExternalUSCCareers/job/Los-Angeles-CA Health-Sciences-Campus/cGMP- Associate ... is seeking a highly motivated individual to join the USC/CHLA Cell Therapy program and cGMP Facility. The successful candidate will work on the process development… more