- Kelly Services (South San Francisco, CA)
- …and agility. **Responsibilities** + ** Lead & Empower:** Steer multiple small molecule CMC projects as the project management lead , championing clear ... Kelly(R) Science & Clinical is seeking a CMC Project Manager for a one-year contract opportunity with a leading biopharmaceutical company in South San Francisco,… more
- Takeda Pharmaceuticals (Boston, MA)
- …application is true to the best of my knowledge. **Job Description** **Title: CMC Project Manager** **Location: Cambridge, MA (Hybrid)** **About the role:** As ... a CMC Project Manager, you will provide ...a CMC Project Manager, you will provide project management...management of one or more small molecule products as co- lead with the CMC Lead ;… more
- AbbVie (North Chicago, IL)
- …to interface with the CMC Regulatory group. Develop standard processes and lead CMC project teams in planning, preparation, review and approval ... impact assessment, and implementation of new regulatory requirements. Will lead CMC Coordination activities for later stage...CMC Regulatory and Process R&D. + Partner with CMC Regulatory to assist CMC project… more
- Boehringer Ingelheim (Ridgefield, CT)
- …Director/Senior Associate Director of EACD for drug product develops non-traditional BI CMC project strategies for drug substance and drug product development ... NCEs and NCE-like projects. * Introduce new practices and technologies and lead project /technology transfer to late Development, Operations. Provision of DS/DP… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Global CMC Automation and Robotics Leader **Location:** Framingham, MA or Cambridge, MA or Waltham, MA **About the Job** Are you ready to shape ... We are seeking a highly motivated and skilled Global CMC Automation & Robotics Leader . As a...CMC /process development with automation/robotics experience, you will define, lead and execute our automation and robotics strategy across… more
- BeOne Medicines (San Mateo, CA)
- …and process optimizations on relevant topics. **Essential Functions of the job:** + Lead , develop and implement small molecule CMC regulatory strategies as well ... authoring CTD CMC sections for the assigned project to ensure on-time and high-quality global submissions for...CMC regulatory strategies for the assigned projects. + Lead regulatory risk assessment, identify key CMC … more
- Lilly (Philadelphia, PA)
- …to make life better for people around the world. **Organizational Overview:** CMC Project Management is responsible for leading the creation, development, ... development and financial acumen to enable investment strategies and optimization at both project and portfolio level. + Drive cross-functional CMC teams to… more
- Kelly Services (Malvern, PA)
- …cross-functional departments + Participate in and/or lead cross-functional meetings with CMC and project team representatives and stakeholders + Lead ... of API clinical materials per Chemistry, Manufacturing, & Controls ( CMC ) timelines. **New Product Introduction (NPI) Tech Transfers** +...GMP production of DS clinical supplies + Setup and lead project kickoff meetings, weekly work-cells, and… more
- Sanofi Group (Cambridge, MA)
- …Familiarity with cGMP and regulatory requirements on analytical methods + Prior CMC project management experience + Excellent communications skills **Preferred ... **Job Title** : Analytical Principal Scientist (Analytical team lead ) **Location:** Cambridge, MA **About the Job** Are...team meetings + Having a record of success in CMC project management + Having working knowledge… more
- Genentech (South San Francisco, CA)
- …they will collaborate with leads from other functions on all aspects of CMC project deliverables. Key collaborators and interfaces include Quality, Genentech ... Analytical Development and Quality Control (ADQC) organization is a leader in developing, validating, and executing physico-chemical, immunochemical, and biological… more
- AbbVie (North Chicago, IL)
- …Purpose: The PDS&T Parenterals/Eye Care group is seeking a motivated Scientist as a CMC drug product project lead , specifically for parenteral drug product ... or under the direction of a more senior scientific leader . This position will be an integral part of...Lead cross-functional PDS&T product teams and represent the CMC team and/or PDS&T in interface with PDS&T leadership,… more
- Lilly (Indianapolis, IN)
- …with other Lilly chemists, analytical chemists, bioconjugation scientists, engineers, CMC project management, Lilly manufacturing partners, and regulatory ... life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover… more
- ThermoFisher Scientific (San Diego, CA)
- …quality systems and compliance activities, including audit functions, as needed. + Serves as a stability lead for a CMC project team or a working group. + ... periods. + Generates stability protocols, reports, and presentations. + Ability to lead multiple stability programs with moderate to high complexity within CMC… more
- Sanofi Group (Framingham, MA)
- **Job Title:** Global Regulatory Affairs CMC lead **Location:** Framingham, MA, Morristown, NJ **About the Job** Are you ready to shape the future of medicine? ... critical in helping our teams accelerate progress. As GRA CMC Lead within our GRA CMC...+ Develop risk mitigation strategies + Communicate implications to project teams + Articulate risk/benefit components to stakeholders **Contribute… more
- Organon & Co. (Jersey City, NJ)
- …science, data science, clinical operations, regulatory affairs, chemistry, manufacturing and control ( CMC ), project management and other partner groups as part ... **Job Description** **The** **Position** The Director, Clinical Pharmacology Lead will be responsible for contributing and/or devising the clinical pharmacology… more
- Organon & Co. (Plymouth Meeting, PA)
- …regulations and guidance, and Organon procedures. The Associate Principal Scientist will lead the preparation and submission of CMC dossiers for life-cycle ... are not limited to: **Responsibilities** + Serve as the CMC Product Lead for assigned products and...Lead development and execution of global product and project regulatory strategy(ies) by ensuring robust assessment of … more
- Boehringer Ingelheim (Duluth, GA)
- …strategies for chemical, biotech and vaccine products. The incumbent may serve as a Global Regulatory Project Lead within the project core team or serve as a ... Boehringer Ingelheim's high regard for our employees. The Director, Scientific Expert CMC is responsible for providing new product and marketed product regulatory… more
- Lilly (Indianapolis, IN)
- …life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover ... better for people around the world. Lilly is looking for post approval regulatory CMC scientists to join us in delivering life-changing new medicines to patients who… more
- Lilly (Indianapolis, IN)
- …life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover ... better for people around the world. Lilly is looking for post approval regulatory CMC scientists to join us in delivering life-changing new medicines to patients who… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …projects and data types. **POSITION ACCOUNTABILITIES:** + Contribute to and/or serve as lead representing data science function on project teams in support of ... shine? Join us as a Senior Manager of Statistics- CMC in our Cambridge, MA office. As a Senior...design, analysis, and interpretation of Chemicals, Manufacturing, and Controls ( CMC ) study data throughout Pharmaceutical Sciences. We seek an… more