- 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 ... to formulate regulatory strategies for post-approval changes. This role will also lead CMC regulatory strategy development and implementation in coordination… more
- Merck & Co. (Rahway, NJ)
- …to customers both internal and external to GCS and serves as the lead GCS spokesperson at clinical and development related meetings.- Working independently, the ... process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients… 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 ... and?guidance, and?Organon procedures.? The Associate Principal Scientist will lead the?preparation and submission of CMC dossiers?for life-cycle maintenance… more
- Programmable Medicine Operatin (Redwood City, CA)
- …options. The Company also offers participation in the annual bonus program. At the Associate Director level, the salary range for this position is $160,000 - ... company Key Responsibilities Act as drug substance and drug product technical lead for small molecule programs and dendrimers manufacturing Oversee the execution of… more
- Organon & Co. (Plymouth Meeting, PA)
- …or Executive Director in Organon Regulatory Chemistry, Manufacturing and Controls ( CMC ), the Associate Principal Scientist is responsible for developing and ... with global regulations and guidances, and Organon procedures. The Associate Principal Scientist will lead the preparation and submission of CMC dossiers… 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. (Plymouth Meeting, PA)
- …teams (ADTs). This position will report to the Non-Clinical Safety Assessment Lead . The NCD team is comprised of non-clinical drug development scientists ... regulatory affairs, safety and pharmacovigilance, Chemistry, Manufacturing and Controls ( CMC ), medical affairs and business development. Non-Clinical Safety Assessment… more
- Endo International (Horsham, PA)
- …everyone we serve live their best life. **Job Description Summary** The Associate Director , Manufacturing Operations will provide leadership and management of ... manufacturing including Upstream Processing, Downstream Processing, and Manufacturing Support. The Associate Director is a member of the site leadership… 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 ... activities within the project(s), in support of CMC development within EACD. The Associate Director /Senior Associate Director of EACD for drug… more
- AbbVie (North Chicago, IL)
- …assure timely impact assessment, and implementation of new regulatory requirements. Will lead CMC Coordination activities for later stage and more complex ... interface with the CMC Regulatory group. Develop standard processes and lead CMC project teams in planning, preparation, review and approval of sections of … more
- BeOne Medicines (San Mateo, CA)
- …and process optimizations on relevant topics. **Essential Functions of the job:** + Lead , develop and implement small molecule CMC regulatory strategies as well ... CMC regulatory strategies for the assigned projects. + Lead regulatory risk assessment, identify key CMC ...+ Lead regulatory risk assessment, identify key CMC regulatory issues and mitigation activities needed throughout product… more
- Kelly Services (South San Francisco, CA)
- …rate:** $60-80/hour Be at the forefront of innovative small molecule drug development as the Associate Director of Project Management, CMC . You will play a ... objectives and timelines with precision and agility. **Responsibilities** + ** Lead & Empower:** Steer multiple small molecule CMC...** Lead & Empower:** Steer multiple small molecule CMC projects as the project management lead ,… 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 ... be fully onsite. In this role, you will have the opportunity to: + Lead Program and Project Execution: Oversee the planning, execution, and successful delivery of… more
- Sumitomo Pharma (Lincoln, NE)
- …seeking a dynamic, highly motivated, and experienced individual for the position of ** Associate Director , Regulatory Affairs (Oncology).** The Associate ... registration strategy of the product + Supports the global regulatory lead (GRL) and the CMC regulatory lead in the formulation of regulatory strategy,… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** GRA Device Lead ( Associate Director ) -...of products. The team is part of the GRA CMC & GRA Device Department within Global R&D. The ... Digital Health **Location:** Cambridge, MA/ Morristown, NJ **About the Job** GRA Device Lead ( Associate Director ) - Digital Health Are you ready to shape the… more
- Sanofi Group (Framingham, MA)
- **Job Title:** GRA Device Lead ( Associate Director ) **Location** : Morristown, NJ/ Cambridge, MA/ Framingham, MA **About the Job** Are you ready to shape the ... of products. The team is part of the GRA CMC & GRA Device Department within Global R&D. The...Supply, Regulatory Health Authorities, and others. As GRA Device Lead in the GRA Device Specialty Care Device and… more
- AbbVie (North Chicago, IL)
- …and efficient operations and maintenance of AbbVie's automated laboratory systems. Lead the daily operation of automation capabilities through continuous systems ... automation systems strategy and roadmap in alignment with department objectives and SM CMC R&D strategies. . Develop and revise project plans and budgets, work with… 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 ... drug product at CDMOs + Design and lead method validation and implementation activities for drug substance and drug product ensuring compliance with relevant ICH and… more
- Takeda Pharmaceuticals (Boston, MA)
- …best of my knowledge. **Job Description** **Summary:** The Regulatory Data Governance Lead will ensure Regulatory information and data standards are aligned with ... quality, usability, and compliance with internal and external standards. + Lead or support activities related to metadata management, including sensitive data… more
- Takeda Pharmaceuticals (Boston, MA)
- …application is true to the best of my knowledge. **Job Description** **Title: Associate Director -Process Engineer SM API Process Sci** **Location: Cambridge, MA ... (Hybrid)** **About the role:** As an Associate Director -Process Engineer SM API Process Sci,...Other key functional groups such as Global Quality, Regulatory CMC etc. **Leadership** + Provide vision and strategy for… more
