- Gilead Sciences, Inc. (Foster City, CA)
- …Join Gilead and help create possible, together. **Job Description** We are seeking an Associate Director , Regulatory Affairs CMC candidate to sit at our ... Foster City, CA site. **Responsibilities:** + The CMC Regulatory Affairs Associate Director at Gilead is responsible for providing strategic direction,… 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 Development… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders. **Summary** CMC Lead is responsible for supporting the overall CMC strategies within ... project needs and the respective development stage of the project. The CMC Lead will support the Sr. CMC Lead on complex and/or late-stage project or act as main… more
- WuXi AppTec (Cranbury, NJ)
- …drug). We greatly simplify the TIDES drug development by providing all discovery, CMC development, and the entire manufacturing supply chain under one roof. **Please ... of relevant pharmaceutical or biotech industry experience in discovery chemistry, CMC process development and/or GMP manufacturing. + Working knowledge and… more
- Merck (North Wales, PA)
- **Job Description** This Associate Principal Scientist position is equivalent to an Associate Director position. Under direction from a Director , the ... and guidance for combination products (Drug and Drug Device combinations). The Associate Principal Scientist is responsible for the preparation and submission of… more
- Boehringer Ingelheim (Ridgefield, CT)
- …We realize that our strength and competitive advantage lie with our people. The Associate Director , US Product CMC Regulatory Affairs is responsible for ... supplemental applications and post marketing reports per US FDA regulations. The Associate Director , US Product CMC Regulatory Affairs acts as primary… more
- Takeda Pharmaceuticals (Boston, MA)
- …**Job Description** **OBJECTIVE / PURPOSE** + Providesprogram leadership and develops CMC regulatory strategy in support of global vaccine programs in various ... world-wide + Demonstrates leadership and comprehensive understanding of global vaccines CMC regulations and guidelines by applying interpersonal skills and expert… more
- Sanofi Group (Cambridge, MA)
- **Job title** : Digital Product Owner ( Associate Director /Senior Manager) In Silico CMC **Location:** Cambridge, MA, Framingham, MA or Morristown NJ **About ... help us get new medicines to patients faster and more efficiently. As an Associate Director /Senior Manager Product Owner for in silico CMC , you will join a… more
- Rhythm Pharmaceuticals (Boston, MA)
- …and distribution quality culture across the board. The Manager QA will report to the Associate Director , QA CMC , based in The United States, while supporting ... review, and approval of relevant SOPs and work instructions relevant to CMC activities. Qualifications and Skills + Bachelor's degree in pharmaceutical life sciences… 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 ... manages the scientific and regulatory efforts of the team, overseeing CMC regulatory activities for global submissions and interactions with regulatory authorities… more
- ThermoFisher Scientific (Boston, MA)
- …pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits. Reporting to the Associate Director , CMC QC Stability, will be ... responsible for managing routine operations of the cell banks, critical intermediates, Drug Substance and Drug Product for clinical GMP stability programs of cell and genetic therapies while ensuring compliance with SOPs, internal policies and industry… 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
- Otsuka America Pharmaceutical Inc. (Rockville, MD)
- **Job Summary** Associate Director , Quality Control, Biologics is responsible for late development stage through commercial biologic products including product ... scientific disciplines to drive programs through critical milestones. Collaborate with CMC teams and demonstrating ability to understand and communicate impact of… more
- Merck (Durham, NC)
- **Job Description** The Associate Director - Purification Technology Lead within the Vaccine Technical Operations organization will be responsible for tactical ... and strategic decisions related to tech transfer and process stabilization. The Associate Director will ensure optimized product quality and manufacturing… more
- Merck (West Point, PA)
- **Job Description** We are seeking a highly motivated individual for the role of Associate Director , Biologics Drug Substance Lead within the Enterprise Go To ... Chain. The end-to-end scope includes Drug Substance for all large molecules. The Associate Director is expected to contribute to ongoing business process… more
- Vera Therapeutics (Brisbane, CA)
- Title: Associate Director , Project Management Location: Brisbane, California About Us: Vera Therapeutics (Nasdaq: VERA), is a late clinical-stage biotechnology ... immunological diseases. Position Summary We are seeking a highly skilled and motivated Associate Director , Project Management. The ideal candidate will work with… more
- Taiho Oncology (Princeton, NJ)
- Associate Director , Product Development Princeton, NJ, USA...a new and exciting role as part of growing CMC group at Taiho. You will be responsible not only ... the oncology space this is the role for you. Position Summary: + The Associate Director , Product Development will be responsible for product development, scale… more
- Lilly (Indianapolis, IN)
- …of the scorecards with the 3rd parties. The key responsibilities for a business/operations Associate Director or Director may include: + Works with BRD, ... from vendors by effective communication between vendor, finance and CMC PM teams. + Manage the collection of performance...early or late phase and basic technical understanding of CMC functions and roles. + Preference for experience working… more
- WuXi AppTec (Atlanta, GA)
- **Overview** ** Associate Director , Project Management (Oligo and Peptide)** **Area of focus: Discovery or medicinal chemistry** **Job Location: Remote USA with ... simplify the TIDES drug development by providing all discovery, CMC development and the entire manufacturing supply chain under...+ Work closely with team members across all Discovery, CMC related business units and with the WuXi-TIDES management… more
- Lilly (Indianapolis, IN)
- …scale-up/optimization for Ph3 and commercial launches. **Responsibilities:** The Assoc. Director of TS/MS enables Operational Excellence by ensuring strong ... agenda via the Commercialization Lead Team ensuring alignment and communication with CMC and Oncology Business Unit. + Benchmark and network with other Lilly… more
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