- Merck & Co. (North Wales, PA)
- …is responsible for developing and implementing Chemistry, Manufacturing, and Controls ( CMC ) regulatory strategies for our organization's biologics product ... Scientist is responsible for the leading the preparation and submission of CMC sections for commercial or new biologics products. The Principal Scientist will… more
- Novo Nordisk Inc. (Boulder, CO)
- …new laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality , Regulatory, Technical Operations and RNAi ... the Department The Boulder Site is home to the specialized technical operations/ CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the… more
- Merck & Co. (Rahway, NJ)
- …process and product development and manufacturing and ensure safety and quality of our products. -The successful candidate will be accountable for proactive ... Analytical Research and Development, Biologics Process Research and Development, CMC and Regulatory in aspects of control strategy and...of and hands-on work in applying regulatory guidance and quality standards related to product release and… more
- Catalent (St. Petersburg, FL)
- …regulatory filings.Catalent is committed to a Patient First culture through excellence in quality and compliance , and to the safety of every patient, consumer ... Process for new materials if required.Provides project support for new product development which requires a close working relationship directly with Customers… more
- Regeneron Pharmaceuticals (Troy, NY)
- The CMC Product Quality Flavor Management team is hiring. The CMC Product Quality Compliance Specialist is responsible for being a Quality ... commercial programs. This role supports the development, coordination and ownership of the quality and compliance elements of the life cycle strategy, including… more
- 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
- Merck (North Wales, PA)
- …is responsible for developing and implementing Chemistry, Manufacturing, and Controls ( CMC ) regulatory strategies for our organization's biologics product ... Scientist is responsible for the leading the preparation and submission of CMC sections for commercial or new biologics products. The Principal Scientist will… 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
- Bristol Myers Squibb (Devens, MA)
- …Analytical Development, Manufacturing Sciences and Technology, Supply Chain, Regulatory, Quality , Process Sciences, Drug Product Development, Project Management, ... for a multitude of products or major brands (Biologics) for the Global Quality Analytical Science & Technology organization. This role requires matrix leadership of… more
- Pfizer (Andover, MA)
- …+ Demonstrated commitment and dedication to scientific & regulatory integrity and to quality compliance + Ability to learn and navigate tracking/change control ... achieve objectives. + Ensure regulatory conformance & consistency globally in compliance with external regulatory requirements and internal quality procedures.… 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
- Bristol Myers Squibb (Summit, NJ)
- …author CMC sections or responses to queries, as needed. + May represent Global Product Quality in CMC meetings with global regulatory agencies and during ... Quality (QA/QC) and Internal/External Operations to ensure regulatory compliance of GMP operations in support of the assigned...+ May represent Quality in the Global CMC and Commercialization teams + Supports the Product… 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
