- Sanofi Group (Morristown, NJ)
- **Job Title:** Head of Global Regulatory Affairs, CMC Small Molecule **Location:** Morristown, NJ **About the job** Join the engine of Sanofi's mission - where ... possible for millions. **Our Team/ Overview:** The Global Regulatory Affairs (GRA) CMC & Device Organization serves as a critical strategic partner within Sanofi's… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Building** + Develop a roadmap that fosters innovation to assist where and when CMC RA invest resources and budget. + Own continuous improvement of the operating ... model and capability roadmap for the CMC RA function. + Creating and implementing functional business...strategic initiatives, centralize activities, and foster cross-functional support of CMC RA's processes, systems, data, and tools. + Define… more
- Takeda Pharmaceuticals (Lexington, MA)
- …and transformation with direct influence on the company's success and future growth. Reporting to the Head of GMSci CMC , you will: + Set and own the CMC ... the role** Join us as our **Global Manufacturing Sciences CMC Lead** and drive **high-impact, high-visibility CMC ...Sciences CMC Lead** and drive **high-impact, high-visibility CMC projects for innovative biologics in a dynamic global… more
- Sanofi Group (Framingham, MA)
- **Job Title:** CMC Project Manager **Location:** Framingham, MA **About the Job** Join the engine of Sanofi's mission - where deep immunoscience meets bold, ... could turn the impossible into possible for millions. The CMC Project Manager is a key contributor of the...challenge the status quo **Potential Career evolution** + Country Head of Project Excellence + Global Project Manager +… more
- Takeda Pharmaceuticals (Lexington, MA)
- …of my knowledge. **Job Description** **About the role** Join us as our ** CMC Sr. Project Lead** , **_Global Biologics Manufacturing Sciences_** _(GMsci Bio)_ and ... expertise for strategic initiatives and Chemistry, Manufacturing and Controls ( CMC ) Life Cycle management (LCM) activities, utilizing technology platforms to… more
- Takeda Pharmaceuticals (Boston, MA)
- …combination products, while bringing the current products to today's standards. + Represent CMC and GRA on key governance committees and play a critical role in ... representative on the Small Molecule quality council and in collaboration with head of Small Molecule and Oncology quality, enable proactive approaches to… more
- Sanofi Group (Waltham, MA)
- **Job Title:** Global Head of Research and Biomarkers- Vaccines **Location:** Waltham, MA **About the Job** Join the team protecting half a billion lives every year ... mRNA platform that brings together R&D, digital capabilities, and CMC expertise under one roof. Bring your ambition and...cutting-edge mRNA technology! In this role, the CTO, Global Head of Research & Biomarkers will be overseeing the… more
- Sanofi Group (Swiftwater, PA)
- **Job Title:** Head of MSAT Viral and bacterial platform and Vaccines Business Partner **Location:** Swiftwater, PA **About the Job** Join a global network that ... methods that support Sanofi's best-in-class ambition. **Position Overview** As Global Head of MSAT Viral & bacterial platform and Vaccines Business Partner,… more
- J&J Family of Companies (Spring House, PA)
- …Description:** Johnson & Johnson Innovative Medicine is recruiting for a **Sr Director, Head of Data Science & Digital Health - Therapeutics Development & Supply ... discovery and clinical application, encompassing Chemistry, Manufacturing & Controls ( CMC ), Device Development, and Clinical Supply Chain. This organization ensures… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …and help create more tomorrows. **Job Description** **Executive Director, Global Supply Chain, Head of Planning** Everyone at Kite is grounded by one common goal - ... looking for an Executive Director of Global Supply Chain, Head of Planning reporting to the Vice President of...Packaging & Labeling operations. Serves as advocate to shape CMC strategy and product decisions, deliver TechOps readiness for… more
- Gilead Sciences, Inc. (Foster City, CA)
- …aspirations. Join Gilead and help create possible, together. **Job Description** ** Head of Manufacturing Strategy and Operations, Foster City, CA** Gilead Sciences ... is currently seeking a Head of Manufacturing Strategy and Operations, who will design...The ideal candidate would also have: + Experience with CMC requirements for drug development and manufacturing of a… more
- Takeda Pharmaceuticals (Boston, MA)
- …of pharmaceutical development and understand the global regulatory trends for CMC activities, to proactively shape strategies and ensure robust and high-quality ... of the global regulatory environment and evolving expectations relation to CMC , process development, and manufacturing of biologics. + Demonstrated ability to… more
- Takeda Pharmaceuticals (Lexington, MA)
- …forums and external regulatory dialogues. + Collaborate with Regulatory, Engineering, CMC , Safety, Commercial Quality, and Digital teams to support patient-centric ... innovation. + Champion quality system initiatives and inspection readiness efforts, including preparation and leadership during internal and external audits. + Establish and monitor performance indicators to ensure continuous improvement in device and software… more
- Takeda Pharmaceuticals (Boston, MA)
- …to increase business performance, organizational efficiency while increase speed for CMC deliverables, including AI-forward projects and mindset. + Partner with PS, ... lead enterprise-wide transformation initiatives, with a focus on increasing CMC productivity of a minimum 5% per year and...as the strategic partner and advisor to the SVP, Head of Pharmaceutical Sciences, driving execution of the organization's… more
- Takeda Pharmaceuticals (Boston, MA)
- …to the best of my knowledge. **Job Description** **_Objective / Purpose:_** The Head of Design & Delivery, PharmSci will lead the global digital product strategy ... & Technology (DDT) portfolio driving innovation and operational excellence across the CMC lifecycle. This leadership role is accountable for shaping and delivering… more
- Sanofi Group (Washington, DC)
- …(Translational and Early Development) team supports Vaccine R&D under the supervision of the head of Preclinical or Non-Clinical Team and/or the TED Global head ... support in R&D for pre-clinical work, bioassay and biomarker research and/or CMC , biological assay, and biomarker research. He/She will work in close collaboration… more
- CSL Behring (King Of Prussia, PA)
- …Global Regulatory Affairs Strategy Team (GRAST) GRL plus other regional, labeling and CMC GRAST members to ensure 'One GRA Voice', appropriate inputs into risk ... to product health authority interaction with support GRL or Regulatory TA Head . Partner with GRAST members to achieve regulatory deliverables (including leading… more
- Alloy Therapeutics (Waltham, MA)
- …and develop AntiClastic RNA medicines. The Role This position reports to the Head of Nucleic Acid Chemistry. We are seeking a detail-oriented Nucleic Acid Chemistry ... to join our growing Nucleic Acid Chemistry team supporting the CMC development of oligonucleotides, mRNA, pDNA templates, and antibody-oligonucleotide conjugates… more
- Gilead Sciences, Inc. (Washington, DC)
- …(internally and externally) for Quality Policy issues in conjunction with the Gilead CMC Regulatory Policy Office. The role will be focused primarily on the North ... guidance and have clear messaging. The role will report directly to the Global Head of Quality Policy and Advocacy **JOB DESCRIPTION** + Serve as critical and… more
- Otsuka America Pharmaceutical Inc. (Waltham, MA)
- …Senior Director will serve as the Translational Medicine CNS Therapeutic Area Head , reporting to the VP, Translational Medicine and Early Clinical Development within ... & Analytics, Early Commercial, Medical Affairs, Nonclinical Toxicology, Clinical Pharmacology, CMC , and Global Pharmacovigilance. + Support and guide team through… more