- Bristol Myers Squibb (Indianapolis, IN)
- …aims to be the global leader in radiopharmaceuticals. **Summary** The Associate Director of Chemistry, Manufacturing & Controls ( CMC ) - Quality Assurance ... drives Quality (manufacturing and analytical) strategies for CMC activities (drug substance, API, drug product, and analytics)...following. Other duties may be assigned. + Member of CMC Development Teams providing Quality (QA) input… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- Regeneron Cell Medicine is looking for an Associate Director in Regulatory CMC for biologics who will be responsible for the development and submission of ... CMC regulatory strategies and the preparation and submission of high‑ quality CMC sections of INDs, CTAs, and original marketing applications (BLAs/MAAs), in… more
- Lilly (Indianapolis, IN)
- …are determined to make life better for people around the world. **Purpose:** The Senior Director of Global Regulatory Affairs - CMC (GRA- CMC ) leads and ... Communicates regulatory decisions and strategy to stakeholders in development, manufacturing, and quality + Ensures that global CMC regulatory commitments are… more
- Atlantic Health System (Pompton Plains, NJ)
- …proficiency and follows testing procedures and policies by adherence to quality assurance guidelines for equipment and work area, documenting corrective action ... laboratory technology/ medical or clinical laboratory science preferred + Associate 's degree in chemical, physical or biological science or...enters one of our facilities, will receive the highest quality care delivered at the right time, at the… more
- Atlantic Health System (Pompton Plains, NJ)
- …+ Operate, maintain, and troubleshoot laboratory analyzers and equipment + Perform quality control tasks and maintain laboratory documentation according to SOP + ... laboratory technology/ medical or clinical laboratory science preferred + Associate 's degree in chemical, physical or biological science or...enters one of our facilities, will receive the highest quality care delivered at the right time, at the… more
- BeOne Medicines (Emeryville, CA)
- **_General Description:_** Sr. Manager/ Associate Director , Supply Chain CMO Management & PM will own and enable the communication, coordinate tasks between the ... strategic initiatives with Contract Manufacturers (CMO) + In partnership with Quality , CMC , Procurement, Supply Planning to ensure manufacturing performance,… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- Regeneron's Quality Control group, located in Tarrytown NY, is seeking an Associate Director . In this exciting role you will be responsible for the oversight ... (BAS). **A Typical Day in the role of an Associate Director Might Look Like:** + Demonstrate...10+ years of relevant scientific experience. Experience overseeing a quality function in support of bioanalytical, CMC ,… more
- Rhythm Pharmaceuticals (Boston, MA)
- …experienced and highly motivated individual to join its team in Boston, Massachusetts. The Associate Director will be the technical lead for Drug Product small ... creates Requests for Proposals (RFPs). + Collaborates with internal stakeholders, including CMC Drug Substance, Supply Chain Management, Quality , and Regulatory… more
- Takeda Pharmaceuticals (Lexington, MA)
- …application is true to the best of my knowledge. **Job Description** ** Associate Director , Clinical Research, Value & Evidence Generation, US Medical** ... regular reporting (eg, key product dashboards, financial aspects) are delivered with high quality and partner with TA Project Managers as necessary. + Oversees &… more
- University of Southern California (Los Angeles, CA)
- cGMP Associate Director , Process DevelopmentApply (https://usc.wd5.myworkdayjobs.com/ExternalUSCCareers/job/Los-Angeles-CA Health-Sciences-Campus/cGMP- ... cell and gene therapies and other biological products for internal/external users. The Associate Director of Process Development (cGMP) is responsible for all… more
- Amgen (Thousand Oaks, CA)
- …team. Join us and transform the lives of patients while transforming your career. ** Associate Director of Engineering - Synthetic & Hybrid DS** **What you will ... to positively impact patients' lives? Amgen is seeking an Associate Director of Engineering in the Drug...+ Adheres to and drives all standards for safety, quality , and compliance + Maximizes performance through the continuous… more
- RTX Corporation (Pueblo, CO)
- …**Security Clearance:** None/Not Required Collins Aerospace is seeking an experienced Associate Director of Carbon Engineering (AD-CE). This position reports ... directly to the Director of Carbon Engineering in Pueblo, CO. This role...Springs, CA. The three sites are referred to as Associate Manufacturing Facilities (AMF) as part of Troy, OH… more
- Takeda Pharmaceuticals (Boston, MA)
- …for the following job opportunity: **JOB LOCATION:** Cambridge, MA **POSITION** : Associate Director , Regulatory Data Governance Lead **POSITION DESCRIPTION** : ... Takeda Development Center Americas, Inc. is seeking an Associate Director , Regulatory Data Governance Lead with...Lead efforts in defining appropriate metrics to measure the quality of the metadata relative to usability and compliance… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …Develop and Execute Global Regulatory Strategies: Formulate and lead global CMC and clinical regulatory strategies for Biologics, Biosimilars, and Small ... filings (eg, BLA, MAA). Identify required documentation and ensure timely, high- quality submissions meeting global requirements. + Health Authority Interactions and… more
- Insight Global (Conshohocken, PA)
- Job Description A growing pharmaceutical company is seeking a Compliance GXP Associate Director to join their IT organization. The role requires a seasoned ... cross-functionally within the IT organization and with departments such as Quality , R&D, CMC , Legal, HR, and Finance to ensure compliant operation of IT… more
- Sanofi Group (Cambridge, MA)
- **Job title** : GRA Device Lead ( Associate Director ) **Location:** Cambridge. MA **,** Morristown, NJ **About the Job** Are you ready to shape the future of ... of products. The team is part of the Global Regulatory Affairs, Regulatory CMC and Device Department within Global Research and Development. The selected candidate… more
- AbbVie (Cambridge, MA)
- …to ensure an in-depth understanding of the science behind each of these opportunities. The Associate Director , Search & Evaluation will be a key member of the ... to lead/manage multifunctional teams to evaluate target opportunities, and produce high quality analyses. Ability to drive projects to deliver timely results and… more
- Bausch Health (Bridgewater, NJ)
- …skills and values drive our collective progress and impact. The Associate Director , Regulatory Affairs handles regulatory development and ... registrations + Manage interactions with other BHC functions (eg, Quality , Compliance) during Regulatory Authority inspections + Provide regulatory guidance/input… more
- Sanofi Group (Cambridge, MA)
- …work in a cutting-edge scientific global crystallization department in Sanofi's R&D CMC Synthetic organization. The job is in Cambridge MA, but close collaboration ... others to develop processes to consistently produce API with the required quality attributes using both batch and continuous platforms. Expectations include; + Team… more