- Regeneron Pharmaceuticals (Troy, NY)
- The CMC Product Quality Regulatory Communications team is hiring! This team is responsible for being the primary Quality representative for product ... This role supports the development, coordination, and ownership of the quality and compliance elements of global regulatory communication/reporting regulations,… more
- AbbVie (North Chicago, IL)
- …project plan to deliver high quality with respect to science, technology, compliance and cost effectiveness. + Leads CMC development teams for assigned ... time, budget and resources. + Develops and implements a CMC product development plan and updates as... CMC activities with respect to science, technology, quality , regulatory/ compliance requirements, budget and resources. *Must… more
- AbbVie (North Chicago, IL)
- …project plan to deliver high quality with respect to science, technology, compliance and cost effectiveness. + Leads CMC development teams for assigned ... teams and all CMC activities with respect to science, technology, quality , regulatory/ compliance requirements, budget and resources. *Multiple product … more
- Teva Pharmaceuticals (West Chester, PA)
- …Sr Director, Regulatory Affairs CMC is responsible for identifying and evaluating CMC issues associated with product development including product and ... of submissions for Teva products, and for ensuring the quality of CMC response to global health...with internal regulatory departments. The Sr Director, Regulatory Affairs CMC will oversee cross functional product teams… more
- Takeda Pharmaceuticals (Boston, MA)
- …pharmaceutical Regulatory CMC experience including experience as an RA CMC product lead, or equivalent industry experience, with international experience ... first time. Maintain up-to-date knowledge and expertise of relevant CMC and quality guidelines and regulations and...proactively and utilize science and risk based approach to product development and LCM activities. + Contribute to creating… more
- Taiho Oncology (Pleasanton, CA)
- …related areas. + In conjunction with Quality Assurance, manages regulatory compliance for sponsor activities for CMC , drug supply, documentation, Good ... Director, Regulatory Affairs CMC Pleasanton, CA, USA Req #355 Tuesday, March...truly global experience that helps cancer patients to improve quality of life . The size of our company… more
- Teva Pharmaceuticals (West Chester, PA)
- … Regulatory Affairs you will also be responsible for identifying and evaluating CMC issues associated with development products, including product and process ... with internal regulatory departments, provide for support cross functional product teams for CMC specific projects and...to establish the regulatory impact of changes and ensure compliance of registered commitments + Assist in planning and… more
- Editas Medicine (Cambridge, MA)
- …or functional teams to provide regulatory guidance and support for CMC development and ensure compliance with applicable EMA/FDA/ICH/WHO/Global regulations ... future. Position Summary This role will lead and support the CMC strategies and submission including clinical trials applications, marketing applications, agency… more
- Takeda Pharmaceuticals (Boston, MA)
- …role will collaborate with multiple stakeholders in R&D, GRA, GMS, Global Quality , and Commercial to develop innovative strategies for the management of development ... + Collaborate with stakeholders in R&D, GRA, GMS, Global Quality , and Commercial to develop innovative strategies for the...and bring current products to industry standards. + Represent CMC and GRA on key governance committees and play… more
- Lilly (Philadelphia, PA)
- …+ Collaborate with global partners and external vendors to ensure timely and quality delivery of CMC activities. + Drive continuous improvement initiatives to ... This position has overall responsibility for Avid's global investigational medicinal product (IMP) manufacturing, IMP and commercial product precursor and… more
- Amgen (Cambridge, MA)
- …for a career you can be proud of. Process Development Senior Principal Scientist - CMC Team Lead **Live** **What you will do** Let's do this. Let's change the world. ... + Serve as the Attribute Sciences team lead on a cross-functional product development team for a biologic in late-stage development with accountability of… more
- Gilead Sciences, Inc. (Foster City, CA)
- …technology development and platform process evolution projects for increased productivity, high quality product , and speed to clinic. + Contribute to design ... Description** **Senior Associate Scientist, Cell Culture Process Development - Pre-Pivotal Biologics CMC Development - Foster City, CA** At Gilead, we're creating a… more
- Takeda Pharmaceuticals (Boston, MA)
- …and right first time. + Maintain up-to-date knowledge and expertise of relevant CMC and quality guidelines and regulations and establishes mechanisms to ... GRA Pharmaceuticals- Small Molecule where you will establish collaboration with Global CMC teams and leadership through networks and enable CMC regulatory… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …to regulatory process optimizations on relevant topics. **Responsibilities** - Supports CMC regulatory compliance activities for portfolio biologics to meet ... Reports, Biological Product Deviation Reports, and Drug Listings. Ensures that CMC documentation is complete, well organized, scientifically sound, of a high … more
- Sanofi Group (Waltham, MA)
- …and Data Quality indicators to bolster data integrity and usability. Compliance with Data Standards: Lead the implementation and monitoring of best practices ... mRNA vaccine capabilities and research platform with R&D, digital, and CMC teams. Watch our Jobinar's replay ( _https://sanofi12.jobinar.com/_ ) to discover… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …more: careers.bms.com/working-with-us . **Drug Product Development (DPD)** Our Drug Product Development team is committed to CMC design, development, and ... Responsibilities** The Senior Scientist will collaborate across BMS sites with Drug Product , Analytical, API, Quality , and Regulatory functions to execute drug… more
- Gilead Sciences, Inc. (Foster City, CA)
- …in the management of filing content and changes. + Evaluates and communicates risks for CMC control strategies and quality compliance to CMC RA ... teams. + Promotes continual improvement for analytical control strategies, quality compliance /business processes, and regulatory filing content taking… more
- Teva Pharmaceuticals (West Chester, PA)
- …filing. Drug Product Development (DPD) is a function within Biologics CMC dedicated to development of formulation, drug product manufacturing process, and ... Scientist, Drug Product Development Date: May 24, 2024 Location: West...and over-the-counter therapies. Located in West Chester, PA, Biologics CMC is a division of Teva Pharmaceuticals responsible for… more
- CSL Behring (King Of Prussia, PA)
- …**Global regulatory experience including knowledge of application submission processes and product life cycle management activities** **( CMC ) knowledge of the ... You will report to the VP, Head of GRA CMC . You will provide strategic leadership and oversight in...requirements. You will lead and direct strategy for regulatory compliance for all CSL Plasma Inc Operations to include:… more
- AbbVie (North Chicago, IL)
- …inside and outside of Biologics CMC Development and R&D. + Assures compliance with AbbVie safety, quality and regulatory policies and government regulations. ... and formulation development. Biologics ARD partners with all functions across Biologics CMC to deliver high- quality drug products for patients. The Director,… more