- Insmed Incorporated (NJ)
- …each other, and for the future of science, we're in. Are you?About the Role:The Associate Director , Regulatory Affairs, CMC will be responsible for reviewing ... formulate regulatory strategies for post-approval changes. This role will also lead CMC regulatory strategy development and implementation in coordination with… more
- Organon & Co. (Plymouth Meeting, PA)
- …Position?** Reporting to the Director in Organon Regulatory CMC ,?the Associate Principal Scientist is responsible for?developing and?implementing Regulatory ... identification of potential risks.? + Execute regulatory strategies by leading the development , authoring and review of CMC submission components and… more
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position** The Associate Director , Biopharmaceutics will provide expert biopharmaceutical guidance on the pharmacokinetic performance ... for the general medicines portfolio of products marketed worldwide. The Associate Director , Biopharmaceutics will also be responsible for contributing… more
- Organon & Co. (Jersey City, NJ)
- …or Executive Director in Organon Regulatory Chemistry, Manufacturing and Controls ( CMC ), the Associate Principal Scientist is responsible for developing and ... identification of potential risks. + Execute regulatory strategies by leading the development , authoring and review of CMC submission components and… more
- Lilly (Philadelphia, PA)
- …of new medicines, and advance care for patients with unmet needs. **Position Overview:** The Associate Director , CMC Development will be responsible for ... the execution of multiple radiopharmaceutical CMC development and manufacturing programs supporting various therapeutic areas within Lilly Avid. In this… more
- Boehringer Ingelheim (Ridgefield, CT)
- …for leading all DP-related activities within the project(s), in support of CMC development within EACD. The Associate Director /Senior Associate ... commensurate upon experience **Compensation Data** This position, Associate Director , External Alternative CMC Development (EACD) , offers a base salary… more
- AbbVie (North Chicago, IL)
- …and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls ( CMC ) works ... to apply and further develop regulatory and technical expertise in small molecule CMC development of peptides and sterile injectables. This individual prepares … more
- AbbVie (North Chicago, IL)
- …aligned closely with the clinical/regulatory development strategy and provides drug development experience and advice to the CMC team. Influences ... responses to questions from regulatory authorities. + Leverage extensive biologics drug development experience to lead the global cross-functional CMC Team in… more
- BeOne Medicines (San Mateo, CA)
- …consistent with company goals. This individual will be responsible for development of strategies, planning, drafting, and managing CMC -related regulatory ... to senior management timely. + Lead or contribute to development of internal small molecule CMC regulatory guidance and working + instructions. + Ensures proper… more
- Sanofi Group (Framingham, MA)
- **Job Title:** Associate Director - CMC BioDPDM **Location** : Framingham, MA As Associate Director within CMC BioDPDM, you'll have the opportunity ... could turn the impossible into possible for millions. The Associate Director role is a key leadership...Director role is a key leadership role in CMC Biologics Drug Product Development and Manufacturing.… more
- Kelly Services (South San Francisco, CA)
- …Be at the forefront of innovative small molecule drug development as the Associate Director of Project Management, CMC . You will play a pivotal ... innovation and operational excellence. You'll work closely with cross-functional leaders across CMC , Drug Development , QA, Regulatory, and external partners to… more
- Danaher Corporation (Fargo, ND)
- …management of already established contracts and project/program execution. This position reports to the Director of Drug Product CMC and is part of the Drug ... of life. At Aldevron, we deliver world-class CDMO services that accelerate the development of groundbreaking therapies. Our mission is to be the engine of innovation… more
- Atlantic Health System (Pompton Plains, NJ)
- …medical laboratory technology/ medical or clinical laboratory science preferred + Associate 's degree in chemical, physical or biological science or medical ... cost. This commitment is also echoed in the respect, development and opportunities we give to our more than...members. Offerings vary based on role level (Team Member, Director , Executive). Below is a general summary, with role-specific… more
- Atlantic Health System (Pompton Plains, NJ)
- …medical laboratory technology/ medical or clinical laboratory science preferred + Associate 's degree in chemical, physical or biological science or medical ... cost. This commitment is also echoed in the respect, development and opportunities we give to our more than...members. Offerings vary based on role level (Team Member, Director , Executive). Below is a general summary, with role-specific… more
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. **Job Summary** The Associate Director of Business Operations will negotiate complex Chemistry, Manufacturing, ... and Controls ( CMC ) contracts while driving digital transformation of CMC...+ Lead and negotiate complex contracts with external Contract Development and Manufacturing Organizations (CDMOs), ensuring favorable terms that… more
- Otsuka America Pharmaceutical Inc. (Salem, OR)
- ** Associate Director , Small Molecule Analytical Development ** + Lead and oversee phase appropriate method development and optimization for drug substance ... and ensure compliance with applicable regulations and guidelines. + Provide CMC functional representation on wider cross-functional program development teams,… more
- Sumitomo Pharma (Lincoln, NE)
- …seeking a dynamic, highly motivated, and experienced individual for the position of ** Associate Director , Regulatory Affairs (Oncology).** The Associate ... investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For...+ Supports the global regulatory lead (GRL) and the CMC regulatory lead in the formulation of regulatory strategy,… more
- Stanford University (Stanford, CA)
- …workshops designed to help students craft their unique career journey after the GSB. The CMC seeks an Associate Director , MBA Career Advising and Education ... Associate Director , MBA Career Advising &...the world. The StanfordGraduate School of BusinessCareer Management Center ( CMC ) is an innovative, high-performing department that annually serves… more
- Sanofi Group (Waltham, MA)
- **Job Title:** Associate Director , Genomic Medicine Purification Process Development **Location:** Waltham, MA Work Model: M-F onsite **About the Job** Are ... race is on to speed up drug discovery and development to find answers for patients and their families....Group located in Waltham, MA in the role of Associate Director . The GMU PPD group operates… more
- University of Southern California (Los Angeles, CA)
- …of cell and gene therapies and other biological products for internal/external users. The Associate Director of Process Development (cGMP) is responsible for ... efficient scaling and implementation. Develop and review SOPs, protocols and process development reports. Authoring CMC documentation. + Oversee lab setup and… more
