- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …teams, developing and executing post-approval Regulatory CMC strategies, reviewing CMC information and data , authoring CMC submissions, and ... research areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Director , Toxicology, is a key member of the nonclinical safety team, reporting ... to the Executive Director , Head of Toxicology and Molecular Mechanisms. In this...represent toxicology at cross-functional project teams, strategize nonclinical safety data package, oversee safety pharmacology and toxicology studies, author… more
- Novo Nordisk Inc. (Boulder, CO)
- …the Department The Boulder Site is home to the specialized technical operations/ CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the ... laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory, Technical Operations and RNAi Early… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as a Director , GRA CMC Pharmaceuticals, Oligonucleotides where you will lead the GRA ... CMC Pharmaceuticals, Oligonucleotides team, you will report to the Executive Director and Head, CMC Regulatory Affairs, Pharmaceuticals. **How you will… more
- Takeda Pharmaceuticals (Boston, MA)
- …order to bring life-changing therapies to patients worldwide. Join Takeda as a Senior Director , GRA Pharmaceuticals- Small Molecule where you will establish ... trade associations and acts as an advisor/ liaison to senior management to plan, evaluate and recommend implementation strategy....CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs -… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …teams, developing and executing post-approval Regulatory CMC strategies, reviewing CMC information and data , authoring CMC submissions, and ... areas centered around rare diseases and immune disorders. **Summary** The Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC … more
- BeiGene (San Mateo, CA)
- **General** **Description:** The Senior Director of CMO and Distribution Logistics, Clinical Supply Chain is responsible for overseeing the Clinical Supply Chain ... leadership (including but not limited to clinical Operation, Quality, Regulatory, CMC , and GRDS) to ensure alignment of organizations and prompt resolution… more
- Boehringer Ingelheim (North Brunswick, NJ)
- …Boehringer Ingelheim has a career opportunity developing pharmaceutical products as a Senior Associate Director , Analytical Development. We are looking for an ... in development. You will represent the Analytical Development function in the CMC -Technical Development Team whenever needed and pro-actively help the team to… more
- Bristol Myers Squibb (Cambridge, MA)
- …and make a difference. As part of the Discovery Biotherapeutics efforts at BMS, the Senior Director of Protein Engineering will play a key role in discovering ... and delivering a first-in-class and best-in-class Biotherapeutics pipeline. The Senior Director , Protein Engineering, will be responsible for leading a team of… more
- Bristol Myers Squibb (Warren, NJ)
- …the Cell Therapy Attribute Sciences group, the energetic and motivated Sr. Director will have overall responsibility for leading the development of scientific ... inform the development of manufacturing processes and analytical tools within a CMC technical development function. The dynamic leader will be tasked with… more
- AbbVie (Irvine, CA)
- …Neurotoxin Research Group at AbbVie seeks an accomplished scientist and leader. The Director / Senior Principal Research Scientist will lead a team performing in ... A key role for the position is partnering with senior management to conceive and provide strategic direction and...external sources into short-term functional objectives * Responsible for data management, data QC, and technical report… more
- Sumitomo Pharma (Columbus, OH)
- …management of the global contract testing laboratories in partnership with the Company's CMC Team. The Associate Director also participates in drafting and ... **Associate Director , GMP Quality Control** Sumitomo Pharma America (SMPA)...with aseptic processing, review media fills, and environmental monitoring data as it relates to lot release, change control… more
- Novo Nordisk (Lexington, MA)
- …through early clinical development. As a primary responsibility, the Medical Director will participate on several cross-functional teams to plan, design, execute, ... interfacing with both internal and external stakeholders including Novo Nordisk senior leadership and external Key Opinion Leaders (KOLs) and Principal Investigators… more
- AbbVie (Madison, NJ)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Senior Manager, Global Regulatory Strategy, US & Canada, AbbVie Inc., Madison / ... changing regulatory and business needs. . Identify and gather data needed to support filings, responses to inquiries, and...and support the Manager, Global Regulatory Lead (GRL), Associate Director , or Director , in the development &… more
- Lilly (Indianapolis, IN)
- …better for people around the world. **Purpose** : The purpose of the Sr. Director role in Global Regulatory Affairs (GRA) - Drug Delivery and Digital Health provides ... clinical trials and market clearance/registrations. It is necessary for the Director to develop collegial and mutually productive relationships across Lilly, partner… more
- University of Southern California (Los Angeles, CA)
- … Director Process DevelopmentApply (https://usc.wd5.myworkdayjobs.com/ExternalUSCCareers/job/Los-Angeles-CA Health-Sciences-Campus/cGMP-Associate- Director ... in compliance with current Good Manufacturing Practices (cGMP). As the Associate Director of Process Development, the individual will be responsible for creating… more
- BeiGene (San Mateo, CA)
- …PK and pharmacometric data analysis. + Analyze, interpret, summarize, and present data to internal project teams, senior management, and to global health ... **_General Description:_** + The Director , Clinical Pharmacology will be responsible for developing and executing clinical pharmacology and pharmacometric strategies… more
- AbbVie (Worcester, MA)
- …discovery, precision medicine, preclinical safety and safety pharmacology, DMPK-BA, CMC , clinical development, and others. Programs may include biologic, genetic ... needed, to carry out key experiments. + Critically analyze data and lead teams to solve issues and make...a variety of audiences including functional heads and other senior leaders. + Position project(s) for seamless transition from… more
- Actalent (Maryland Heights, MO)
- Description: The Lead Chemist will report to the Senior Director of Upstream Development. The successful candidate will serve as a key functional member and will ... Write and provide peer review of technical documents including those supporting CMC regulatory submissions. Participate in development project teams as CMC … more
- Gilead Sciences, Inc. (Foster City, CA)
- …role in the Analytical Development and Operations (ADO) organization reports to the Senior Director of Analytical Development (AD). AD is primarily responsible ... drug candidates, supporting process chemistry and formulation development, and generating data for regulatory submissions. The Principal Scientist will be a… more
