- Merck & Co. (North Wales, PA)
- …will be to lead project management efforts to support Chemistry Manufacturing & Controls ( CMC ) product development from First in Human to Transfer to Supply , ... improve human health and business. - Under GPAM, the CMC Integrated Project Management (CIPM) organization was formed to...- Position Description/Summary: - The CIPM Associate Director, Project Manager , is a core member of DCTs ,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking an Senior Scientist, Statistician CMO MSAT as part of the Global Manufacturing and ... critical process parameters (CPP) data, in-process testing data, and drug product release data to identify out-of-trend performance.Assist investigation and root… more
- Merck & Co. (Rahway, NJ)
- Job Description Job Description: - The drug development Project Manager is part of Global Project and Alliance Management (GPAM) which sits in the Research & ... of our company. - Position Description/Summary: - The GPAM Associate Director, Project Manager , is a core member of Early Drug Development and/or Late Drug… more
- AbbVie (North Chicago, IL)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description + Represents all CMC areas on the AST serving as spokesperson for the CMC ... in communications and meetings with regulatory agencies. Accountable for creating CMC development plan incl. risks and mitigations in collaboration with line… more
- BeiGene (San Mateo, CA)
- …identify key regulatory CMC issues and mitigation activities needed throughout product life cycle. Escalate critical issues to senior management. + Lead ... during product lifecycle for assigned projects. + Provide regulatory CMC review of clinical protocols and investigator brochures, etc. for assigned projects.… more
- AbbVie (North Chicago, IL)
- …The leveling of this position is flexible. Applicants may be considered for the Senior Manager or Associate Director level based on qualifications. This role is ... areas, Operations, and Research & Development (R&D) organizations. Represents CMC on teams such as product development,...organizations. Represents CMC on teams such as product development, Global Regulatory Product Teams, and… more
- Merck (North Wales, PA)
- …will be to lead project management efforts to support Chemistry Manufacturing & Controls ( CMC ) product development from First in Human to Transfer to Supply, ... projects and products that improve human health and business. Under GPAM, the CMC Integrated Project Management (CIPM) organization was formed to enhance our Project… more
- GE Aerospace (Asheville, NC)
- …efficient components to power the worlds aircraft engines of tomorrow. With a product mix including shafts, seals, retainers, and discs, we're bringing quality to ... enhance commercial, military, marine and industrial engine performance. The Quality Manager will be leading a team of quality engineers supporting production of … more
- GE Aerospace (West Chester, OH)
- …improvements for financial processes. + Effectively communicate financials and objectives to senior product line and engineering leadership. + Perform special ... **Job Description Summary** The Senior Engineering Finance Manager , CFM Programs...CMC ) Producibility and Industrialization (P&I), and Additive P&I product lines. Responsible for the financial planning, analysis, reporting,… more
- Takeda Pharmaceuticals (Boston, MA)
- …supporting the strategic direction and translating the cross-divisional, integrated Global Product Team (GPT) strategy into an efficiently executable plan working ... closely with a senior GPM; predicting and planning solutions to achieve program...requirements, and evidence generation/publication needs are incorporated into the product strategy and project plan + Works closely with… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and help create possible, together. **Job Description** **Key Responsibilities** Senior Manager , Global External Manufacturing Biologics supports uninterrupted ... May represent manufacturing on one or more cross-functional Development or Commercial CMC teams with responsibility for proactively managing product strategy… more
- Bristol Myers Squibb (Summit, NJ)
- …at work and in their personal lives. Read more: careers.bms.com/working-with-us . **Title: Manager , Senior Engineer I** **Location: Seattle, WA, Summit, NJ or ... Therapy Manufacturing Processes across the manufacturing network throughout the product lifecycle. The Senior Engineer will be...at a global level. This role collaborates across all CMC functional areas and drug product manufacturing… more
- Integra LifeSciences (Plainsboro, NJ)
- …of us are challenging what's possible and making headway to help improve outcomes. The ** Senior Project Manager ** is a key member of the value stream leadership ... team for Integra's Collagen Manufacturing Center ( CMC ) in Plainsboro, NJ. Reporting to the assigned value stream manufacturing manager , this position is… more
- AbbVie (North Chicago, IL)
- …on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Overview The Senior Program Manager , Factory of the Future (FotF) Transformation will ... will support the development of long-range plan strategy and execution plans. The Senior Program Manager will also support subsequent site discovery and creation… more
- AbbVie (Mettawa, IL)
- …@abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Senior Manager , RA In Vitro Diagnostics and Companion Diagnostics, works ... into the preparation and maintenance of chemistry, manufacturing, and controls ( CMC ) device sections of regulatory submissions, responses to Agency questions for… more
- United Therapeutics (Silver Spring, MD)
- …and pulmonary diseases, and other orphan diseases. **How you'll contribute** The Senior Regulatory Affairs Manager partners with senior regulatory ... Contribute to the development and implementation of sound preclinical, clinical and CMC regulatory strategies that support the clinical and commercial development of… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Senior Manager , Clinical Supplies will manage the complete clinical supply ... but not limited to, Clinical Operations, Chemistry, Manufacturing and Controls ( CMC ), Product Quality Assurance (PQA),Regulatory Affairs and Sourcing… more
- Mallinckrodt Pharmaceuticals (St. Louis, MO)
- …This includes providing analytical chemistry expertise for method development and product improvement initiatives. The Senior Analytical Chemist will be ... Job Title Senior Analytical Chemist Requisition JR000014680 Senior ...established standards, with a key focus on drafting regulatory CMC submission documents. + Develop creative and collaborative solutions… more
- Bausch Health (Petaluma, CA)
- …and designs experiments in accordance with QbD/aQbD principles. Designs and executes CMC studies to support product specifications profile development and ... with accuracy and in accordance with established procedures + Effectively communicates with Manager , team members, and Senior Management + Organized and able to… 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 ... internal engine of innovation includes unrivaled industry leading expertise in CMC development of small molecules, protein biotherapeutics, protein degraders, and… more
