- 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 ... changes in the external environment. + Utilizes scientific and regulatory knowledge to lead preparation, review, and finalization of CMC documents for global… more
- WuXi AppTec (Boston, MA)
- …the US and requires English and Mandarin language skills. **Responsibilities** + Lead all project initiation and planning efforts. Participate in the implementation ... of 5 years of relevant pharmaceutical or biotech industry experience in CMC process development and/or GMP manufacturing. + Working knowledge and understanding of… more
- WuXi AppTec (Cranbury, NJ)
- …STA Pharmaceutical, a WuXi AppTec Company, has an exciting opportunity for an ** Associate Director , CMC Project Management.** This position will be ... responsible for managing DS and DP projects within STA. The position will lead the orderly progression of projects from the proposal stage through project completion… 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 the following duties: Oversee… more
- J&J Family of Companies (Raritan, NJ)
- …**We are searching for the best talent for an Associate Director , Investigational Product Preparation and Strategy.** Beerse, ... Belgium - Requisition Number: R-016743 Associate Director , Investigational Product Preparation and Strategy...and if approved by the Company. **Purpose:** Within the CMC Portfolio Strategy group, you will lead … 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 ... goals. He/she will also work with functions within the company to support and/or lead new product introduction, new market launches as necessary. This role will be… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …globally with Formulation and Analytical Scientists, Clinical Operations, Regulatory Affairs CMC , and Clinical Development to collate the necessary information to ... to steady supply of Clinical Trial Materials (CTM). **Responsibilities** + Lead the authoring, revising, and managing the day-to-day activities associated with… 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** ... objectives include: + Partners with Head of US Medical Clinical Science Lead to translate strategy into efficiently executable research plan; predicting and planning… more
- Bristol Myers Squibb (Seattle, WA)
- …Read more: careers.bms.com/working-with-us . **Position Summary:** The energetic and motivated Associate Director will leverage their technical and operational ... skills to lead a team of scientists executing routine and non-routine...interpret results and communicate with process development engineers and CMC teams. Excellent communication and organization skills are required,… more
- Rhythm Pharmaceuticals (Boston, MA)
- …highly motivated individual to join its team in Boston, Massachusetts. The Associate Director will be the technical lead for Drug Product small molecule drug ... Requests for Proposals (RFPs). + Collaborates with internal stakeholders, including CMC Drug Substance, Supply Chain Management, Quality, and Regulatory Affairs. +… 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...enable successful scale-up and transfer to manufacturing sites. + Lead and manage authoring of technical documentation required for… 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
- 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
- Merck (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
- Amneal Pharmaceuticals (Piscataway, NJ)
- …Essential Functions: + Develop and Execute Global Regulatory Strategies: Formulate and lead global CMC and clinical regulatory strategies for Biologics, ... innovation, and compliance while balancing business benefits and risks. + Lead and Manage Global Submission Activities: Oversee submission planning, authoring,… 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 ... the Company. Review external opportunities for scientific merit and feasibility. + Lead the assessment of opportunities (in conjunction with the R&D Therapeutic Area… more
- AbbVie (North Chicago, IL)
- …/ week* This position can be hired based on the following qualifications below: Associate Director , Clinical Pharmacology: + PhD with typically 4+ years of ... pharmacology strategy; acts as the representative for project(s). + Executes strategy, lead teams and various data analyses and interpretation by providing necessary… more
- BeOne Medicines (San Mateo, 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 ... milestone, and activities for agency filing + Coordinate with the Labeling Lead for the development/maintenance of product labels + Ensure labeling content and… more
- Sanofi Group (Cambridge, MA)
- …We are looking for a highly motivated individual with a mindset to lead the implementation of changes. She/He will be recognized as technical expert in ... 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… more
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