- 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 ... Leads initiatives internal to RA CMC . + Represents CMC regulatory affairs on project initiatives with other functional areas to drive efficiencies across the… more
- BeOne Medicines (San Mateo, CA)
- …implement small molecule CMC regulatory strategies as well as authoring CTD CMC sections for the assigned project to ensure on-time and high-quality global ... product complaints arise during product lifecycle for the assigned project . + Provide CMC regulatory review for...lifecycle for the assigned project . + Provide CMC regulatory review for clinical protocols and investigator brochures,… more
- AbbVie (North Chicago, IL)
- …interface with the CMC Regulatory group. Develop standard processes and lead CMC project teams in planning, preparation, review and approval of sections of ... with CMC Regulatory and Process R&D. + Partner with CMC Regulatory to assist CMC project teams in identifying submission-related risks and develop… 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. You will… more
- Organon & Co. (Jersey City, NJ)
- …**The Position ** Reporting to the Director in Organon Regulatory CMC , the Associate Principal Scientist is responsible for developing and implementing ... and post-approval changes. The incumbent may manage outsourcing partners in support of project execution. The Associate Principal Scientist may also support … more
- Merck (Boise, ID)
- …transfer of process and product knowledge with reduced error rates Digital CMC will implement digital solutions to install the foundational capabilities needed to ... Under the guidance of dCMC Regulatory Authoring Leadership, the Associate Principal Scientist, Regulatory Authoring Business Owner, will optimize regulatory… more
- Sumitomo Pharma (Lincoln, NE)
- …seeking a dynamic, highly motivated, and experienced individual for the position of ** Associate Director , Regulatory Affairs (Oncology).** The Associate ... (HA) information requests. In addition, this position may represent GRA in project related meetings, develop regulatory strategy and provide regulatory input as… more
- AbbVie (North Chicago, IL)
- …and automation systems strategy and roadmap in alignment with department objectives and SM CMC R&D strategies. . Develop and revise project plans and budgets, ... ongoing basis . Provide guidance, technical advice, planning, and project management within SM CMC and with...advice, planning, and project management within SM CMC and with outside functions, consultants, and vendors. Support… more
- Otsuka America Pharmaceutical Inc. (Boise, ID)
- ** Associate Director , Small Molecule Analytical Development** + Lead and oversee phase appropriate method development and optimization for drug substance and ... release testing and reporting, providing actionable insights and recommendations to optimize project outputs for the project teams and ensure alignment with… more
- Emory Healthcare/Emory University (Atlanta, GA)
- …academic community. **Description** The Goizueta Business School is in search of an Associate Director - Graduate Student Advising and Programming to join the ... who is passionate about supporting early-career college and international students. The Associate Director will be responsible for designing, developing, and… more
- Takeda Pharmaceuticals (Lexington, MA)
- …true to the best of my knowledge. **Job Description** **About the role** As Associate Director , API Process Engineering, you will be Takeda's global expert for ... site leadership, Technical Services, Pharmaceutical Sciences, Global Quality, and Regulatory CMC . + Provide technical support to marketing applications for global… more
- AbbVie (Irvine, CA)
- …LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description Purpose The Associate Director , Technical position within the Product, Development, ... responsible for financial planning, budget responsibility and timeline estimates of the project as well as execution. + Responsible for implementation of global… 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 you ... our teams accelerate progress. The Genomic Medicine Unit (GMU) CMC group at Sanofi is dedicated to the establishment...Group located in Waltham, MA in the role of Associate Director . The GMU PPD group operates… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** GRA Device Lead ( Associate Director ) - Digital Health **Location:** Cambridge, MA/ Morristown, NJ **About the Job** GRA Device Lead ( Associate ... of products. The team is part of the GRA CMC & GRA Device Department within Global R&D. The...GRA Device Lead for DHTs and SaMDs on assigned project teams (early phase, late stage and marketed products)… more
- University of Southern California (Los Angeles, CA)
- …cell and gene therapies and other biological products for internal/external users. The Associate Director of Process Development (cGMP) is responsible for all ... including manufacturing and process development activities, in order to ensure that project deliverables meet schedule, cost, scope, quality, and safety and ensuring… more
- AbbVie (North Chicago, IL)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The ME&C Associate Director is a global program management expert responsible ... defined deliverables and milestones. The program manager is to kick-off project /transfer teams, remove barriers to success, realize opportunities, mitigate risks and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Join Gilead and help create possible, together. **Job Description** The Associate Director , Strategic Sourcing & Supplier Management, Medical Devices ... high complexity. + Communicates issues to line manager and project teams in a timely manner + Support product...management software + Understanding of activities related to the CMC development of biopharmaceuticals + Advanced knowledge of GMPs… more
- Lilly (Indianapolis, IN)
- …solutions to support communities through philanthropy and volunteerism. **Responsibilities:** The Associate Director - API EM Engineering Leader for Peptides ... and process improvement. + Demonstrated ability to manage capital delivery project or commercialization / technical agenda projects + Deep technical knowledge… more
- Lilly (Indianapolis, IN)
- …+ Communicate status and manage change via regular updates to management teams, CMC project management, and site leadership. + Deliver customer service for ... manufacturing sites regarding testing needs (investigations, continuous improvement, technical support). + Participate and lead governance processes (change management boards, quality lead teams). + Set laboratory priorities for TS/MS, including direction and… more
- RTX Corporation (Pueblo, CO)
- …Do:** + Leads and directs site-based AMF Program Engineering Senior Managers, Carbon R&D Associate Director and the Dyno Test Lab Manager that report to this ... **Security Clearance:** None/Not Required Collins Aerospace is seeking an experienced ** Director , Materials and Process Engineering.** This role will be responsible… more