- Eisai, Inc (Exton, PA)
- …with Facilities, Quality Assurance, Quality Control, Regulatory, and CMC Program Management departments.The Associate Director of Biologics ... difference. If this is your profile, we want to hear from you. The Associate Director of Biologics Operations Upstream and Downstream is responsible for leading… more
- Merck & Co. (Rahway, NJ)
- …regulatory submissions.-Under the general scientific and administrative direction of the Director in Biologics Cell Culture Sciences group and working in conjunction ... a cross-functional team.-Ensures project results meet requirements regarding technical quality , reliability, schedule, and cost.Monitors performance and recommends schedule… more
- 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
- UTMB Health (Dickinson, TX)
- Mental Health Clinician - CMC - Carole Young **Dickinson, Texas, United States** Social Service UTMB Health Requisition # 2404113 The mission of Correctional Managed ... Works under the supervision of a Psychologist, Mental Health Manager and/or Program Director . **_ESSENTIAL JOB FUNCTIONS_** **:** + Contributes to the success of the… 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
- Merck (West Point, PA)
- …process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients ... a lead GCS Planning program representative) such as clinical development, regulatory, quality and other supply chain areas to negotiate timelines, strategies and… 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
- Bristol Myers Squibb (Devens, MA)
- …in their personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** Director of Validation, Cell Therapy Technical Operations reports to the ... Senior Director , Cell Therapy Technical Operations within the Cell Therapy...deploy global cell therapy validation technical standards via the quality system. + Promote innovative and efficient approaches to… more
