- 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
- AbbVie (North Chicago, IL)
- …for preparation, review and approval of these Chemistry, Manufacturing, and Controls ( CMC ) sections of submission documents. Plays a critical role in ensuring that ... the CMC submission strategy is aligned closely with the clinical/regulatory...drug development experience and advice as appropriate to the CMC team. Responsibilities List up to 10 main responsibilities… 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 (Boston, MA)
- …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
- Boehringer Ingelheim (Ridgefield, CT)
- …and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Associate Director , US Product CMC Regulatory Affairs is responsible ... 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
- Gilead Sciences, Inc. (Foster City, CA)
- …aspirations. Join Gilead and help create possible, together. **Job Description** ** Associate Director , Analytical Regulatory Sciences, Systems & Operations in ... is a site based position located in Foster City, CA_** The Associate Director , Analytical Regulatory Science, collaborates with product development,… 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
- 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
- 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
- Regeneron Pharmaceuticals (Tarrytown, NY)
- We are seeking an ** Associate Director ** within the Formulation Development Group of Regeneron Pharmaceutical Inc. at Tarrytown, NY. This role will lead clinical ... functions and stakeholders including Therapeutic Focus Areas, Pre-clinical Development, CMC and Manufacturing (DS and DP), Program Management, Regulatory, Quality,… more
- WuXi AppTec (Cranbury, NJ)
- **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)
- …solutions to support communities through philanthropy and volunteerism. **Responsibilities** + The Associate Director - Sourcing Manager is a hands-on leadership ... subject matter experts (SMEs), and timely communication with the suppliers. + The Associate Director - Sourcing Manager will ensure compliance with all internal… 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
- Merck (Rahway, NJ)
- …Reporting to the Director of Packaging Commercialization, the Associate Director , Engineering, Packaging Commercialization will lead packaging development ... prior experience developing and commercializing new products on cross-functional teams. The Associate Director will be accountable for the definition and… more
- Lilly (Indianapolis, IN)
- …and drug products. **Responsibilities** Through scientific training and relevant experience, the ( Associate ) Director - Quality and Compliance serves as a key ... resource for all Quality and Compliance related initiatives within SMDD. The ( Associate ) Director : + Manages key compliance activities which include: + SMDD… 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 of ... (BAS). **A Typical Day in the role of an Associate Director Might Look Like:** + Demonstrate...Experience overseeing a quality function in support of bioanalytical, CMC , GMP, or similar activities is also required. \#BioanalyticalSciences… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …company that will inspire you and empower you to shine? Join us as an Associate Director , Global Program Management in our Cambridge, MA office. At Takeda, we ... have responsibility for line management of Sr. Manager and/or Associate Director level GPMs as well as...related functions (eg Clinical Science, Clinical Operations, Research, Regulatory, CMC , Marketing) + Minimum of 5 years program management… more
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