- 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 ... changes, providing regulatory impact assessments, and coordinating with regional RA- CMC leaders to formulate regulatory strategies for post-approval changes. This… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Director , Engineering, Packaging Commercialization will lead packaging development for new products including parenteral products ... erience developing and commercializing new products on cross-functional teams. - - The Associate Director will be accountable for the d efinition and execution… more
- Insmed Incorporated (NJ)
- …other, and for the future of science, we're in. Are you?About the Role:The Associate Director , Quality Control will be responsible for leading and overseeing all ... combination products is preferred.Proficient in regulatory requirements, including cGxP, CMC , ICH, and compendial standards (USP/EP/JP).Excellent analytical and problem-solving… more
- Kelly Services (South San Francisco, CA)
- Kelly(R) Science & Clinical is seeking an Associate Director of CMC Project Management for a one-year contract opportunity with a leading biopharmaceutical ... **Workplace:** Hybrid, onsite in South San Francisco, CA **Position Title:** Associate Director , CMC Project Management **Position Type:** One-year contract… more
- Lilly (Philadelphia, PA)
- …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 capacity, this… more
- Boehringer Ingelheim (Ridgefield, CT)
- …currently seeking an Associate Director or Senior Associate Director to join our External Alternative CMC Development (EACD) department located at ... within the project(s), in support of CMC development within EACD. The Associate Director /Senior Associate Director of EACD for drug product develops… more
- AbbVie (North Chicago, IL)
- …third parties. The primary function is to ensure consistent preparation of CMC regulatory submission documents of high scientific and technical quality that are ... efficient processes for preparation, review and approval of these CMC sections. Plays a critical role in ensuring that...sections. Plays a critical role in ensuring that the CMC submission strategy is aligned closely with the clinical/regulatory… more
- BeOne Medicines (San Mateo, CA)
- …be responsible for development of strategies, planning, drafting, and managing CMC -related regulatory submissions and HA interactions to meet the aggressive ... 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 CTD … 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 ... apply and further develop regulatory and technical expertise in small molecule CMC development of peptides and sterile injectables. This individual prepares CMC… more
- AbbVie (Boston, MA)
- …and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description Purpose: The Associate Director will be fully accountable for providing CMC leadership to both ... commercial and development projects with a focus on biologics drug substance. This role serves as a central leader within the Biologics Development and Launch (BDL) group. Responsibilities: + Develop comprehensive project plans, budgets, timelines and… more
- UTMB Health (Galveston, TX)
- Director of Operations, - CMC - Galveston County Jail **Galveston, Texas, United States** Business, Managerial & Finance UTMB Health Requisition # 2503778 The ... problems through operations analysis and quality assessment. Reports to the Associate Vice President Outpatient Services, Correctional Managed Care. **_ESSENTIAL JOB… more
- Takeda Pharmaceuticals (Boston, MA)
- …is true to the best of my knowledge. **Job Description** **About the role:** As a CMC Lead, Small Molecules ( Associate Director ), you will be responsible for ... **How you will contribute:** + Provide strong direction to CMC Leads to drive effective life cycle management for...the global reporting of process performance. + Lead multiple CMC teams with competing priorities. + Able to determine… 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
- UTMB Health (Huntsville, TX)
- …assigned HIM area with the HIM department. + In coordination with the Associate Director /Manager of Health Information Management hires, counsels, evaluates, and ... Health Inform Mgt, Supervisor - CMC - Huntsville **Huntsville, Texas, United States** **New** Supply Chain Management UTMB Health Requisition # 2505512 The mission… 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 ... the primary liaison for internal project teams, mentoring team members and Associate Project Managers to support their professional growth and ensure high-quality… 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 ... all team members. Offerings vary based on role level (Team Member, Director , Executive). Below is a general summary, with role-specific enhancements highlighted:… 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 ... all team members. Offerings vary based on role level (Team Member, Director , Executive). Below is a general summary, with role-specific enhancements highlighted:… more
- Sumitomo Pharma (Lincoln, NE)
- …seeking a dynamic, highly motivated, and experienced individual for the position of ** Associate Director , Regulatory Affairs (Oncology).** The Associate ... strategy of the product + Supports the global regulatory lead (GRL) and the CMC regulatory lead in the formulation of regulatory strategy, and interactions with HAs… 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, ensuring… more
- Gilead Sciences, Inc. (Foster City, CA)
- …more than 35 countries worldwide, with headquarters in Foster City, California. ** Associate Director , PDM Team System** **_Location: Foster City_** **KEY ... Governance, and part of the larger PDM organization, the Associate Director , PDM Team System will work...tools, training, and support needed to effectively lead PDM ( CMC ) Teams aligned with Gilead's product development goals. +… more
