- BeOne Medicines (Emeryville, CA)
- …assigned projects. The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on relevant topics. ... the job:** + Lead, develop and implement small molecule CMC regulatory strategies as well as authoring...throughout product life cycle. Escalate the critical issues to senior management timely. + Lead or contribute to development… more
- Astellas Pharma (Northbrook, IL)
- …remote work are encouraged to apply. **Purpose and Scope:** We are seeking an experienced CMC Regulatory Affairs Director with deep expertise in the United ... Affairs, Quality Assurance, Business Partners). Responsible for developing regional/global CMC regulatory strategy (eg, CMC strategy/planning for… more
- Lilly (Indianapolis, IN)
- …are determined to make life better for people around the world. **Job Summary** The Director / Senior Director , CMC , Drug Product Development will lead ... capabilities in drug product development and manufacturing + Author CMC sections of regulatory submissions (IND, CTA) related to drug product development and… more
- UTMB Health (Huntsville, TX)
- Technical Supervisor, Lab Serv - CMC - Estelle **Huntsville, Texas, United States** Allied Health UTMB Health Requisition # 2505527 The mission of Correctional ... workflow for the division; and communicate with staff, management, and senior leadership. **_ESSENTIAL JOB FUNCTIONS_** **:** . Responsible for recruitment, hiring,… more
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. **Purpose:** The purpose of the Senior Director Global Regulatory Affairs, Global Regulatory Lead (GRL) ... experience for 10 years + Direct experience in clinical and CMC regulatory sciences + Experience in applicable therapeutic area neuroscience and/or immunology… more
- Lilly (Indianapolis, IN)
- …global regulatory climate and emerging requirements; ability to address key CMC regulatory questions that enable clinical studies and support marketing ... concept) to product commercialization + Experience in development / CMC including quality and regulatory interactions is...in development / CMC including quality and regulatory interactions is expected + Experience with technical transfer… more
- Lilly (Indianapolis, IN)
- …and diverse portfolio of ADCs, we are seeking a highly experienced and strategic Senior Director to lead our payload linker development efforts within the ... + Experience working with ADC projects, especially regarding the unique CMC and regulatory considerations, is a plus. + Strong leadership skills with a… 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 ... discovery and clinical application, encompassing Chemistry, Manufacturing & Controls ( CMC ), Device Development, and Clinical Supply Chain. This organization ensures… more
- Gilead Sciences, Inc. (Foster City, CA)
- …possible, together. **Job Description** **Head of Technical Development Data & Digital Team ( Senior Director )** We are seeking a highly motivated individual to ... join the Technical Development Strategy and Operations team as ** Senior Director of Data & Digital Team**...and partner closely with Technical Development leadership, IT, Manufacturing, CMC Regulatory and the broader Gilead digital… 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
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