- Eisai, Inc (Exton, PA)
- …groups as well as with Facilities, Quality Assurance, Quality Control, Regulatory, and CMC Program Management departments.The Associate Director of Biologics ... your profile, we want to hear from you. The Associate Director of Biologics Operations Upstream and...the technology transfer, scale-up, and optimization of validatable biological Drug Substance (DS) / Antibody Drug Intermediate… more
- Merck & Co. (Rahway, NJ)
- …in cell culture commercialization. The primary objective of the Biologics Drug Substance Commercialization (BDSC), Cell Culture Sciences department is to provide ... regulatory submissions.-Under the general scientific and administrative direction of the Director in Biologics Cell Culture Sciences group and working in conjunction… more
- Bausch Health (Bridgewater, NJ)
- Associate Director , Regulatory Affairs Job Location: Hartford, Connecticut, USA | NewHaven, Connecticut, USA | Stamford, Connecticut, USA | Atlanta, Georgia, USA ... skills and values drive our collective progress and impact. The Associate Director , Regulatory Affairs handles regulatory development and… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director , GRA CMC Small Molecules where you will oversee ... CMC team, you will report to the Senior Director Global Regulatory Affairs CMC . **How you...experience preferred. + Understanding of scientific principles and regulatory CMC requirements relevant to global drug development… more
- Bristol Myers Squibb (Indianapolis, IN)
- …to be the global leader in radiopharmaceuticals. **Summary** The Associate Director of Chemistry, Manufacturing & Controls ( CMC ) - Quality Assurance develops ... and drives Quality (manufacturing and analytical) strategies for CMC activities ( drug substance, API, drug product, and analytics) for compounds in… more
- Lilly (Indianapolis, IN)
- …- Expertise** + Recognized as a deep scientific technical expert in CMC drug development and/or pharmaceutical manufacturing technology and processes. + ... better for people around the world. **Purpose:** The Senior Director of Global Regulatory Affairs - CMC ...knowledge in drug development including API, or Drug Product or Analytical + Demonstrated CMC … more
- WuXi AppTec (Boston, MA)
- …will be responsible for managing projects within STA, WuXi's API, and Drug Product development and manufacturing division. Leads the orderly progression of projects ... CRO/CMO industry experience, preferably in API process R&D and manufacturing and/or Drug Product R&D and manufacturing. + Prior experience in project management or… more
- Organon & Co. (Plymouth Meeting, PA)
- **Job Description** **The Position** The Associate Principal Scientist ( Associate Director ) is responsible for developing and implementing Regulatory ... Chemistry, Manufacturing & Controls ( CMC ) strategies for assigned small molecule and/or biological products...with global regulations and guidances, and Organon procedures. The Associate Principal Scientist will lead the preparation and submission… more
- UTMB Health (Brazoria, TX)
- Mental Health Clinician - CMC - Clemens **Brazoria, Texas, United States** **New** Social Service UTMB Health Requisition # 2503824 The mission of Correctional ... Works under the supervision of a Psychologist, Mental Health Manager and/or Program Director . **_ESSENTIAL JOB FUNCTIONS_** **:** + Contributes to the success of the… more
- Takeda Pharmaceuticals (Boston, MA)
- …staff (employees and/or contractors). + Budget management and sign off at Assoc. Director authorization level, CMC -DP strategy development, implementation, and ... to the best of my knowledge. **Job Description** **Objective:** Under the direction of the Director or Sr. Director , ODPD, the Assoc. Director is responsible… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Associate Director , Drug Substance Commercial Development **Location** : Cambridge, MA **About the Job** Are you ready to shape the future of ... medicine? The race is on to speed up drug discovery and development to find answers for patients...join our growing Commercial Process Development team as an Associate Director . Under the direction of the… more
- Lilly (Philadelphia, PA)
- …determined to make life better for people around the world. **Position Overview:** The Associate Director , Supply Chain will lead and grow a supply chain team ... required for the uninterrupted manufacturing of commercial and clinical radiopharmaceutical drug products across a worldwide network of cGMP manufacturing sites. Key… 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** ... leading cross-functional clinical programs within Medical Affairs, Clinical Research, Regulatory, CMC or other drug development related function. Clinical… more
- RTX Corporation (Pueblo, CO)
- …**Security Clearance:** None/Not Required Collins Aerospace is seeking an experienced ** Associate Director of Carbon Engineering .** This position reports ... Manufacturing Facilities (AMF) as part of Troy, OH Landing Systems. The ** Associate Director of Carbon Engineering** and staff provide timely and effective… 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...on data, coordinating with regulatory teams (eg, submission publishing, CMC , drug labeling, compliance, and IT) to… 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 ... BD goals and to reinforce AbbVie's role as a world-leading pharmaceutical drug developer. Key Responsibilities Include: + Proactively search for, identify, 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 ... EMA, and Health Canada regulations. Assess regulatory impact of changes in CMC procedures and oversee internal regulatory guidance documents. + Support Development,… more
- Bristol Myers Squibb (Summit, NJ)
- …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...This Technical Leadership role will provide Technical oversight to drug product and vector sites, covering process validation for… more
- BeOne Medicines (Emeryville, CA)
- **General Description:** The Associate Director , Clinical Pharmacology & Pharmacometrics will be responsible for developing and executing clinical pharmacology ... cross-functional teams such as Clinical Development, Biometrics, Biomarkers, Regulatory, CMC etc. Responsibilities will include planning and reviewing study designs… more
- Bausch Health (Bridgewater, NJ)
- …skills and values drive our collective progress and impact. The Associate Director , Regulatory Affairs handles regulatory development and ... product/dossier management lifecycle, including Development, Promotion and Advertising, Labeling, CMC , Commercialization, and Operations + Knowledge of domestic and… more
