- Merck & Co. (Rahway, NJ)
- …further investment. Stakeholder Management & Communication: The analyst will organize and lead information gathering sessions with the internal CMC community, ... Under the guidance of dCMC Regulatory Authoring Leadership, the Senior Specialist, Regulatory Authoring Business Analyst,-will optimize regulatory authoring… more
- Merck & Co. (Rahway, NJ)
- …(DCT) leader is-accountable for delivering a fully integrated stage-appropriate CMC development and commercialization strategy which yields the target commercial ... options analysis and provides recommendation to governance for endorsement.Represent CMC and effectively communicates across the governance bodies, stakeholders and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Microbial Process Operations (MPO) Team is seeking a Senior Principal Scientist with expertise in microbial process development for the production ... biomolecules, including novel biotherapeutics, vaccines, and engineered enzymes.As a senior scientific leader, the successful candidate will shape strategy, drive… more
- Merck & Co. (Rahway, NJ)
- …state-of-the-art facility, that is a key part of our Chemistry, Manufacturing, and Controls ( CMC ) hub at our site headquarters in Rahway, NJ. This facility will be ... test documents. Limited off shift work may be required to meet project , operations, and qualification needs.Execute and develop appropriate system validation, change… more
- Larimar Therapeutics (Philadelphia, PA)
- …using its novel cell penetrating peptide technology platform. Our lead product candidate, Nomlabofusp (CTI-1601), is a subcutaneously administered, recombinant ... discovery, non-clinical and clinical development, regulatory affairs, manufacturing and CMC . Our company's strategy is to become a leader...Regulatory Affairs Director will be a key member of project teams and the role reports to the Regulatory… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …PA or Somerset, NJ. Role OverviewWe are seeking a highly experienced and strategic Senior Director of Toxicology to lead and oversee all nonclinical safety ... scientific rigor in support of our pipeline of advanced therapies.This is a senior leadership position that requires deep expertise in toxicology as applied to CGT… more
- Takeda Pharmaceuticals (Lexington, MA)
- …**How You Will Contribute** Reporting to Head of GMSci Bio Program Management, you + Co- lead CMC project teams for complex biologic products and guide ... my knowledge. **Job Description** **About the role** Join us as our ** CMC Sr. Project Lead ** , **_Global Biologics Manufacturing Sciences_** _(GMsci Bio)_… more
- Otsuka America Pharmaceutical Inc. (Augusta, ME)
- …interpretation of regulatory guidelines and perspective to the cross-functional team. Serve as CMC regulatory lead on global project teams (Pharmaceutical ... to Health Authority questions and deficiency letters. + Represents CMC RA in project team meetings and... CMC related matters. Prepare briefing packages and lead CMC discussions during regulatory interactions as… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …innovation-driven company that will inspire you and empower you to shine? Join us as a Senior Manager of Statistics- CMC in our Cambridge, MA office. As a ... projects and data types. **POSITION ACCOUNTABILITIES:** + Contribute to and/or serve as lead representing data science function on project teams in support of… more
- Takeda Pharmaceuticals (Lexington, MA)
- …**Job Description** **About the role** Join us as our **Global Manufacturing Sciences CMC Lead ** and drive **high-impact, high-visibility CMC projects for ... edge of process technology. In this role, you will lead cross‑functional CMC teams, represent Global Manufacturing...strengthen supply reliability. + Collaborate closely with an assigned CMC Project Manager (who will provide you… more
- Astellas Pharma (Northbrook, IL)
- …Affairs Director with deep expertise in the United States regulatory frameworks and global CMC strategy. This role will lead the development and execution of ... PRIME, Project Orbis, and other rapid-review designations. The candidate will lead the development and implementation of forward-leaning CMC approaches that… more
- BeOne Medicines (San Mateo, CA)
- …and process optimizations on relevant topics. **Essential Functions of the job:** + Lead , develop and implement small molecule CMC regulatory strategies as well ... authoring CTD CMC sections for the assigned project to ensure on-time and high-quality global submissions for...throughout product life cycle. Escalate the critical issues to senior management timely. + Lead or contribute… more
- Merck (West Point, PA)
- …(DCT) leader is accountable for delivering a fully integrated stage-appropriate CMC development and commercialization strategy which yields the target commercial ... and a robust commercial supply chain to achieve uninterrupted long-term supply + Lead DCT. Critically assesses all team deliverables & fosters a learning and… more
- Genentech (South San Francisco, CA)
- …+ Enable open and timely communication with senior management regarding CMC issues and resolutions. Facilitate project status reports, governance committee ... innovation, and regulatory expectations. Additionally, you will oversee portfolio execution, CMC project management, and a team of technical development… more
- Takeda Pharmaceuticals (Lexington, MA)
- …is true to the best of my knowledge. **Job Description** **Title: Senior Manager, Commercial Biologics Product Science Lead ** **Location: Lexington, MA ... own analytical comparability strategies and non‑GMP analytical methods for assigned products. + Lead preparation and review of CMC dossier sections related to… more
- Lilly (Indianapolis, IN)
- …as purification, isolation, and formulation. The position presents an opportunity to lead CMC activities to support clinical trials and regulatory submissions ... amenable to efficient drug substance manufacturing. + Collaborate across internal CMC networks (Drug Product Delivery, Project Management, Quality,… more
- Gilead Sciences, Inc. (Foster City, CA)
- …than 35 countries worldwide, with headquarters in Foster City, California. ** Senior Director,** **Product Management** **Team** ** Lead ** **(Early Phase)** ... the broader Pharmaceutical Development and Manufacturing (PDM) organization, the ** Senior Director, Product Management Team Lead ** will... Director, Product Management Team Lead ** will lead a team of product and project … more
- Amgen (Thousand Oaks, CA)
- …and transform the lives of patients while transforming your career. **Process Development Senior Scientist** **What you will do** Let's do this. Let's change the ... Amgen's Commercial Attribute Sciences group in Thousand Oaks, California is seeking a Senior Scientist. The successful candidate will join us on our effort to… more
- J&J Family of Companies (Spring House, PA)
- …Johnson & Johnson Innovative Medicine R&D is recruiting for a Senior Principal Scientist, Nonclinical Safety Lead within Preclinical Sciences ... will be located in Spring House, PA. As a Senior Principal Scientist, Nonclinical Safety (NCS) Lead ,...humans and ultimately through global registration. Principal Responsibilities: + Lead PSTS project teams of nonclinical safety… more
- The US Pharmacopeial Convention (USP) (Rockville, MD)
- …work environment. **Brief Job Overview** USP is seeking a Senior Technical Advisor, Pharmaceutical Formulation and Manufacturing Strategy with strengthening ... to promote engaged, collaborative, and results-driven work environments. The ** Senior Technical Advisor, Pharmaceutical Formulation and Manufacturing Strategy** has… more
