- Editas Medicine (Cambridge, MA)
- …cross-functional teams in the execution of these submissions. Key Responsibilities: + As the Director , Regulatory CMC , you will be responsible for: + Provide ... in the Editas regulatory affairs organization by keeping abreast of global CMC regulatory requirements and ensure that project team colleagues and management… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as a Director , Regulatory Affairs Vaccines CMC where you will provide program ... leadership and develop CMC regulatory strategy for global vaccine programs in various stages of development. You will represent the vaccine regulatory … 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- Small Molecule...CMC teams and leadership through networks and enable CMC regulatory team's success in meeting goals/objectives.… more
- Sanofi Group (Framingham, MA)
- …to process development activities. + Broad knowledge of (bio)pharmaceutical development and CMC activities in a regulatory context, including good understanding ... discovery and development to find answers for patients and their families. The CMC -Biologics Statistics team is seeking an expert data scientist / Statistician to… more
- Sanofi Group (Cambridge, MA)
- …products within the Sanofi portfolio of products. The team is part of the Global Regulatory Affairs, Regulatory CMC and Device Department within Global R&D. ... **Job title: Device Regulatory Lead (Associate Director )** + Location: Bridgewater, NJ or Swiftwater, PA or Cambridge, MA **About the job** The Global … more
- Bristol Myers Squibb (Devens, MA)
- …reference standards, and comparability studies. In addition, the ASL Associate Director will be accountable for enabling regulatory filings (analytical ... personal lives. Read more: careers.bms.com/working-with-us . **Position:** ASL Associate Director , Analytical Strategy & Lifecycle Group Lead **Location** :… 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)
- … Work with the Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams. Will be interfacing with both ... ready to make a difference? The Position The Medical Director serves as the subject matter expert for our...with, Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams to deliver… more
- Editas Medicine (Cambridge, MA)
- …distribution of non-GMP materials at all locations. Key Responsibilities: As the Sr. Director , Supply Chain, you will be responsible for: + Building out all aspects ... and Technical Operations and partner with leadership in TechOps, ClinOps, Finance, CMC and Program Teams to lead short-term integrated production and raw materials… more
- Takeda Pharmaceuticals (Lexington, MA)
- …in leading cross-functional clinical programs within Medical Affairs, Clinical Research, Regulatory , CMC or other drug development related function. + ... with significant experience within related functions (eg, Medical Affairs, Clinical Operations, Regulatory , CMC , Marketing). + Minimum of 5 years' experience as… more
- Novo Nordisk (Watertown, MA)
- …drug substance and resolve technical issues or deviations + Author and review relevant CMC sections for US and ex-US regulatory filings, including NDAs + Work ... Development - Boston and will work closely with other functions of CMC drug development, including Drug Product, Analytical Sciences, Quality Assurance, and Supply… more
- Novo Nordisk (Lexington, MA)
- …a living. Are you ready to make a difference? The Position The Senior Director can be accountable for the Clinical pharmacology strategy for phase 1-4 in Clinical ... Will interact with Medical Specialists, Clinical Operations, Medical writing, Regulatory , Data Science (statistics, pharmacometrics), Research and Early Development,… more
- Orchard Therapeutics (Boston, MA)
- … Regulatory Science team managing submissions for late-stage programs, and/or to the Regulatory CMC team, on an ad hoc basis. This position offers ... Location: London, UK (or Boston, US) Reporting to: Director , Regulatory Science Early-Stage Programs Job Summary This role will report to the Director , … more
- Bristol Myers Squibb (Cambridge, MA)
- …a difference. As part of the Discovery Biotherapeutics efforts at BMS, the Senior Director of Protein Engineering will play a key role in discovering and delivering ... a first-in-class and best-in-class Biotherapeutics pipeline. The Senior Director , Protein Engineering, will be responsible for leading a team of 20+ scientists… more
- Sanofi Group (Waltham, MA)
- …pace, working with other global project team members including physicians, regulatory leaders, CMC representatives, discovery scientists, and assay development ... around the world. Sanofi is recruiting for a Deputy Director of Clinical Immunology to support a diverse and...of clinical protocols, provide scientific and technical support for regulatory communications and filings, as well as define the… more
- Sanofi Group (Framingham, MA)
- Associate Director , Commercial Cell Culture Development Location: Framingham, MA **About the Job** Are you ready to shape the future of medicine? The race is on to ... Join our global Cell Culture Development (CCD) organization as the Associate Director , Commercial Cell Culture Deveopment with the mission to develop robust,… more
- Lilly (Cambridge, MA)
- …improvements in healthy outcomes for our customers. We are seeking an Executive/Senior Director - DDCS Drug Delivery and New Product Innovation to partner with R&D ... the Medicines Innovation Hub and the Business Units, as well as leaders in Regulatory and Manufacturing to define and deliver our strategy. This individual will be… more
- ThermoFisher Scientific (Waltham, MA)
- …experience in Pharmaceutical Industry, including Manufacturing, Quality Control, Quality Assurance, CMC , Regulatory or related compliance experience with at ... in the mission to holistically assess the state of quality and regulatory compliance across PSG global manufacturing/testing sites via fully independent audit… more
- Bristol Myers Squibb (Devens, MA)
- …experience in one or more areas (ie, research, analytical, quality, engineering, manufacturing, regulatory CMC , or IT). + Proven ability to understand complex ... data stewardship supporting acquisition and divestiture data migrations, ensuring contractual/ regulatory obligations are met. + Drive business related archival… more
- Takeda Pharmaceuticals (Boston, MA)
- …empowering environment. As part of the SMPD team, you will report to Director , Process Chemistry TMA. Our Synthetic Molecule Process Development (SMPD) team develops ... chemical processes for drug substance manufacture, enduring compliance with regulatory standards. + Collaborate with our Pharmaceutical Sciences colleagues and… more