- Actalent (Boston, MA)
- …to Boston area to accommodate flexible hybrid schedule Responsibilities: + Actively represent Regulatory CMC and provide regulatory expertise as a member ... to agency questions, and maintenance activities. + Coordinate and drive regulatory CMC submissions, including assembling necessary cross functional teams… more
- Actalent (Boston, MA)
- …compliance requirements. Reviews proposal in final stage prior to Research Administrative Director signature and submission to sponsor. + Assists PI with posting ... support to RAD on special projects as necessary. + Works with Research Administrative Director , Research facilities and PI with on boarding of new lab staff and lab… more
- Takeda Pharmaceuticals (Lexington, MA)
- … where you will independently develop and lead the execution of regulatory CMC investigational, registration and/or pos-approval strategies for assigned products ... CMC team, you will report to the Senior Director GRA CMC and work cross functionally...Guide the team to define and drive strategy for CMC regulatory dossier content and reviews this… more
- Takeda Pharmaceuticals (Boston, MA)
- … Regulatory Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC . **How you will contribute:** + Independently ... life-changing therapies to patients worldwide. Join Takeda as a Director , GRA CMC Small Molecules where you...where you will oversee the development and execution of regulatory CMC development and registration strategies. RA… more
- Takeda Pharmaceuticals (Boston, MA)
- …the Regulatory Affairs CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs - Pharmaceuticals. **How you will ... therapies to patients worldwide. Join Takeda as a Senior Director , GRA CMC Pharmaceuticals Development Portfolio Lead...CMC teams and leadership through networks and enable CMC regulatory team's success in meeting goals/objectives.… more
- Takeda Pharmaceuticals (Boston, MA)
- …knowledge. **Job Description** Takeda Development Center Americas, Inc. is seeking an Associate Director , CMC Program Lead, Cell Therapies in Cambridge, MA with ... and product quality improvement in Chemistry, Manufacturing & Control ( CMC ) processes; Employ technical project management principles (project planning, RACI,… more
- Takeda Pharmaceuticals (Boston, MA)
- …a network of company Subject Matter Experts across Global R&D (Pharmaceutical Sciences, CMC Regulatory Affairs & Devices), Global Manufacturing Supply and Global ... events. + He/she must have a depth of experience in defining global Regulatory CMC strategy, superb collaboration skills, rapid, disciplined decision making and… more
- Merck (Boston, MA)
- …pivotal leadership role within the organization, overseeing the quality assurance and regulatory CMC for complex medical devices, including auto-injectors and ... **Job Description** The Executive Director , Device Quality & Regulatory will...oversight of product validation, verification, and risk mitigation activities. Regulatory CMC Oversight + Lead the preparation… more
- Sanofi Group (Cambridge, MA)
- …an **Analytical Development Director ** to lead the analytical group in our CMC function at Cambridge Crossing site, which is part of the synthetic platform ... **Job Title:** Analytical Development Director + **Location:** Cambridge, MA **About the Job**...within Global CMC Development. We are striving to become an industry… more
- Takeda Pharmaceuticals (Boston, MA)
- …Provides strategic scientific leadership and program management for multiple global CMC development teams dealing with complex development programs that require ... as functional expert in divisional and cross-divisional initiatives. + Represents CMC on cross-divisional governance and development teams while providing strategy… more
- Novo Nordisk (Lexington, MA)
- …Development, Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams. Will be interfacing ... + Work with, Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams to deliver and drive the… more
- Sanofi Group (Waltham, MA)
- **Job title: Director Non-clinical Biostatistics - Vaccines** + Location: Swiftwater, PA or Waltham, MA (must have ability to work onsite 2-3 days per week per ... Join our Translational and Nonclinical Biostatistics team in Sanofi Vaccines as the ** Director of Non-clinical Biostatistics** where you will lead a team of experts… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …their teams in the field of analytical controls and compliance + Global CMC program oversight of Pharmaceutical Sciences (PS) with management and oversight of all ... Contribute to overall functional direction globally and represent function within CMC /Pharmaceutical Science and across the global Takeda organization. + Implement… more
- Takeda Pharmaceuticals (Lexington, MA)
- …BLA/MAA regulatory submissions. Knowledgeable in European, Japanese, Chinese and US CMC regulatory requirements for Biologics + Represents AD and provide ... of my knowledge. **Job Description** **Objective / Purpose:** As an Associate Director in Analytical Development, it is expected that the individual will… more
- Organon & Co. (Boston, MA)
- …cross-functional colleagues in preclinical science, data science, clinical operations, regulatory affairs, chemistry, manufacturing and control ( CMC ), project ... position can be 100% remote in the US** The Director , Translational Medicine and Early Development (TMED) Lead will...are sound, based on the most up-to-date literature and regulatory guidances and support the approved early development plans.… more
- Editas Medicine (Cambridge, MA)
- …The individual will also be a key contributor to the overall program CMC strategy. This role requires strong technical expertise in LNP manufacturing process design ... passion to lead, mentor and influence people. Characterizing Your Impact: As the Associate Director , LNP Process Development you will: + Lead and grow a team of… more
- Takeda Pharmaceuticals (Boston, MA)
- …development functions. + Prepare and coordinate completion of technology transfer documentation, CMC sections of regulatory documents, or validation plans and ... and transfer; + Ability to design and direct analytical strategy to meet CMC project objectives. + Experience in preparing regulatory documentation. **More about… more
- Takeda Pharmaceuticals (Boston, MA)
- …that will inspire you and empower you to shine? Join us as an Executive Director , Global Program Leader (GPL) in our Cambridge office. At Takeda, we are transforming ... versatile and strong enterprise leaders + be committed to simultaneously driving regulatory approval as well as product launch and global patient access +… more
- Schrodinger (Cambridge, MA)
- We are looking to hire a ** Director , GxP Quality Assurance and Compliance** to join us in our mission to discover and develop drugs that improve human health through ... the oversight of cross-functional teams, including members of our toxicology, bioanalytical, CMC , and clinical teams **What you will do:** + Overall GxP… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …you'll be a leader on cross-functional program teams (spanning research, clinical, CMC , quality, regulatory , finance, and alliance management) solving complex ... We are seeking an enthusiastic **Associate Director , Program & Portfolio Management** to drive programs...IND-enabling studies through clinical study execution. **As an Associate Director , Program & Portfolio Management at RCM, a typical… more