- Organon & Co. (Plymouth Meeting, PA)
- …, regulatory affairs, safety and pharmacovigilance, Chemistry, Manufacturing and Controls ( CMC ), medical affairs and business development are critical to ... oversee non-clinical activities and safety assessments for Organon Research and Development (R&D) programs ranging from discovery through late-stage development .… more
- Lilly (Indianapolis, IN)
- …better for people around the world. **Job Summary** The Director / Senior Director , CMC , Drug Product Development will lead formulation development ... external providers (CROs, CDMOs) with capabilities in drug product development and manufacturing + Author CMC sections...drug product development and manufacturing + Author CMC sections of regulatory submissions (IND, CTA) related to… more
- Xeris Pharmaceuticals, Inc. (Chicago, IL)
- …Health Authority questions. + Supports the preparation and management of complex CMC development plans including long-range planning. + Collaborates with other ... **Overview** The Director , CMC provides leadership for the... provides leadership for the Chemistry, Manufacturing and Controls ( CMC ) function for Xeris' commercial and clinical/late-stage development… more
- Amgen (Washington, DC)
- …modeling for CMC development and commercial support. Reporting to the Senior Director , CMC Statistics, you will drive innovation in kinetic modeling, ... CMC data, spanning drug substance, drug product, and delivery device development . As Director , CMC Modeling & Advanced Statistics, you will: + Provide… more
- Astellas Pharma (Northbrook, IL)
- …work are encouraged to apply. **Purpose and Scope:** We are seeking an experienced CMC Regulatory Affairs Director with deep expertise in the United States ... regulatory frameworks and global CMC strategy. This role will lead the ...partners; with global health authorities at review, management and senior staff, including negotiations on controversial areas. Established rapport… more
- BeOne Medicines (San Mateo, CA)
- …critical issues to senior management timely. + Lead or contribute to development of internal small molecule CMC regulatory guidance and working + ... consistent with company goals. This individual will be responsible for development of strategies, planning, drafting, and managing CMC -related regulatory… more
- J&J Family of Companies (Spring House, PA)
- …of America **Job Description:** Johnson & Johnson Innovative Medicine is recruiting for a ** Sr Director , Head of Data Science & Digital Health - Therapeutics ... scientific discovery and clinical application, encompassing Chemistry, Manufacturing & Controls ( CMC ), Device Development , and Clinical Supply Chain. This… more
- Lilly (Indianapolis, IN)
- …of ADCs, we are seeking a highly experienced and strategic Senior Director to lead our payload linker development efforts within the Antibody-Drug Conjugate ... to ensure manufacturability and facilitate smooth transition from early research to CMC development . + Develop scalable, robust, and reproducible processes for… more
- Lilly (Indianapolis, IN)
- …development cycle (proof of concept) to product commercialization + Experience in development / CMC including quality and regulatory interactions is expected ... life better for people around the world. The Synthetic Molecule Design and Development (SMDD) is responsible for the development of synthetic drug substances… more
- Lilly (Indianapolis, IN)
- …novel technologies, innovative business relationships, and world class systems. The Senior Director , Strategic Alliances position seeks a collaborative, ... our world's greatest health challenges. In Product Research and Development (PRD), we transform molecules into medicines. Our portfolio...supply of material for toxicology and clinical trials. The Senior Director role will be critical to… more
- Lilly (Indianapolis, IN)
- …make life better for people around the world. **Purpose:** The purpose of the Senior Director Global Regulatory Affairs, Global Regulatory Lead (GRL) role is to ... assigned therapeutic area. The GRL is the accountable decision maker for the development & execution of global regulatory strategies from portfolio entry to end of… more
- Gilead Sciences, Inc. (Foster City, CA)
- …together. **Job Description** **Head of Technical Development Data & Digital Team ( Senior Director )** We are seeking a highly motivated individual to join ... Technical Development Strategy and Operations team as ** Senior Director of Data & Digital Team**... Strategy and Operations and partner closely with Technical Development leadership, IT, Manufacturing, CMC Regulatory and… more
- ThermoFisher Scientific (Greenville, NC)
- **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Job Description** ** Senior Director Project Mgmt - Oversight** At Thermo Fisher ... general medicine and vaccines. **Discover Impactful Work:** We are seeking a ** Senior Director , Project Management** in our **Non-Interventional Oversight Team… more
- ThermoFisher Scientific (Greenville, NC)
- …gaining cross-cultural experience. **Discover Impactful Work:** We are seeking a ** Senior Director , Project Management** in our **Oversight Respiratory Trials ... individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in… more
- Gilead Sciences, Inc. (Foster City, CA)
- …aspirations. Join Gilead and help create possible, together. **Job Description** ** Senior Director ,** **External Q** **uality Testing** **Operations** This role ... team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our...External Quality is currently seeking a leader at the Senior Director level to lead a team… more
- Lilly (Indianapolis, IN)
- …creative solutions to support communities through philanthropy and volunteerism **Position Summary:** The Senior Director of TSMS - Tech Transfer is a strategic ... across transfers. **Strategic & Portfolio Management** + Partner with CMC PMs and development teams to guide tech transfer execution using Lilly's Single… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …(edaravone) oral suspension in 2022. The company handles research, clinical development , sales, marketing, medical affairs, supply chain, and business development ... on real-world evidence, and creating hope for all facing illness. The Senior Manager, Supply Chain leads, develops, establishes, and manages the supply chain… more
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. **Overview:** We are seeking a Senior Director , ADC Process Development , to lead and expand our growing ... CMC PM) and external CDMOs to align and execute the CMC development plan. + Create and update end-to-end capacity models, provide important data for… more
- Otsuka America Pharmaceutical Inc. (Waltham, MA)
- …VP, Translational Medicine and Early Clinical Development within OPDC's Early Development Organization (EDO). The Senior Director Translational Medicine ... Experts reporting to her/him on the early development CNS portfolio and Early Development Teams. This Senior Director is a strategic scientific and… more
- Lilly (Indianapolis, IN)
- …make life better for people around the world. **Purpose:** The purpose of the Senior Director , Global Regulatory Affairs, Global Regulatory Lead (GRL) role is to ... assigned therapeutic area. The GRL is the accountable decision maker for the development & execution of global regulatory strategies from portfolio entry to end of… more
