- AbbVie (Irvine, CA)
- …. Job Description Further develop your expertise and join our team as Director , CMC Product Development . Must have Medical ... Device experience. The Product Development Director (PDD) will be a member...requirements, budget and resources. + Multiple product development experiences of leading a CMC team… more
- Gilead Sciences, Inc. (Foster City, CA)
- …inflammation, and serious respiratory and cardiovascular conditions. **KEY RESPONSIBILITIES** The Director , CMC Regulatory Affairs for Biologics is responsible ... multiple products. + Lead the execution and influence the development of global CMC regulatory strategies, including...risk mitigation strategies to ensure right first-time approvals of product submissions. + Lead the execution of these global… more
- BeOne Medicines (Emeryville, CA)
- …of relevant pharmaceutical or biopharmaceutical industry experience in innovative drug CMC development , manufacturing, Quality, etc. including minimum 8 years ... team in US. * Lead or/and oversee the development and implementation of biologics regulatory CMC ...or/and oversee regulatory risk assessment, identify key biologics regulatory CMC issues and mitigation activities needed throughout product… more
- BeOne Medicines (San Mateo, CA)
- …consistent with company goals. This individual will be responsible for development of strategies, planning, drafting, and managing CMC -related regulatory ... CMC regulatory issues and mitigation activities needed throughout product life cycle. Escalate the critical issues to senior...to senior management timely. + Lead or contribute to development of internal small molecule CMC regulatory… more
- Gilead Sciences, Inc. (Foster City, CA)
- …scientific knowledge, and company policies and procedures. + Develops and implement CMC regulatory strategies, guiding teams across product lifecycle stages. + ... member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we… more
- Catalent Pharma Solutions (San Diego, CA)
- **Title: Director Product Development ** **About Catalent San Diego:** Catalent, Inc. is a leading global contract development and manufacturing ... is seeking a dynamic leader to join us as Director , Product Development . The ...clients meet their objectives. + Provide direction for the development of drug CMC efforts including toxicology… more
- Gilead Sciences, Inc. (Foster City, CA)
- …manufacturing, or supply chain, or quality, or CMC regulatory, or process development , or as part of a cross-functional product team in the broader ... 35 countries worldwide, with headquarters in Foster City, California. **Executive Director , PDM Product Strategy Leader** **KEY RESPONSIBILITIES** Reporting to… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Notified Body Option). + Provide oversight for changes to drug substance and drug product CMC details. + Accountable for PAI/PLI readiness and supports Gilead ... of patients with life-threatening illnesses worldwide. Gilead Sciences is currently seeking an Director level position to be a Product Quality Lead (PQL),… more
- University of Southern California (Los Angeles, CA)
- … Director , Process DevelopmentApply (https://usc.wd5.myworkdayjobs.com/ExternalUSCCareers/job/Los-Angeles-CA Health-Sciences-Campus/cGMP-Associate- Director ... and other biological products for internal/external users. The Associate Director of Process Development (cGMP) is responsible...the design and production of viral vectors. Support assay development and qualification for product testing. +… more
- Amgen (Thousand Oaks, CA)
- …team. Join us and transform the lives of patients while transforming your career. ** Director , Small Molecule Process Development ** **What you will do** Let's do ... Thousand Oaks, CA headquarters and reports to the Senior Director of Process Development . + Accountable for...scientific theory + Strong experience with regulatory requirements for API/ Product ( CMC for IND/NDA, GLP/GMP, ICH) +… more
- BeOne Medicines (Emeryville, CA)
- …in a scientific field. Minimum 10 years' experience within biopharmaceutical/pharmaceutical CMC development , GMP and regulatory requirements **Computer Skills** ... **_General Description:_** Sr. Manager/Associate Director , Supply Chain CMO Management & PM will...functions within the company to support and/or lead new product introduction, new market launches as necessary. This role… more
- Ascendis Pharma (Palo Alto, CA)
- …a proven ability to partner effectively with multiple functions, including Clinical development , Research, Product Development , Medical Affairs, Commercial ... section of the JD. Key Responsibilities + Collaborate with Clinical Development , Pharmacovigilance, Biometrics, Core Team Members, Product Management, and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we ... countries worldwide, with headquarters in Foster City, California. **Executive Director , Global Clinical Supply Chain (GCSC)** **KEY RESPONSIBILITIES:** Executive … more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …pharmacology** submission documents and representative of the department at different product development team meetings. You will participate in pharmacometrics ... development including nonclinical pharmacology/toxicology, ADME, clinical, regulatory, and CMC . Work with formulation, biomarker and bioanalytical team members on… more
- Gilead Sciences, Inc. (La Verne, CA)
- …member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we ... Responsibilities:** + Lead strategy and execution of complex sterile product qualification activities. + Expertise in contamination control, cleaning validation… more
- Northrop Grumman (San Diego, CA)
- …Enabling Products** is a leading producer of Ceramic Matrix Composites ( CMC ) components. The COIC organization is seeking a highly qualified, mission-oriented ... team which provides various markets with critical Ceramic Composite Matrix ( CMC ) oxide and non-oxide products including applications in commercial power, exhaust… more
- Northrop Grumman (San Diego, CA)
- …Enabling Products** is a leading producer of Ceramic Matrix Composites ( CMC ) components. The COIC organization is seeking a highly qualified, mission-oriented ... CA** which provides various markets with critical Ceramic Composite Matrix ( CMC ) oxide and non-oxide products including applications in commercial power, exhaust… more
- Actalent (Carlsbad, CA)
- …and drug product samples. + Good understanding of the drug development process. + Practical knowledge of GMP requirements, with hands-on GMP experience ... executing testing of drug substance intermediate, drug substance, and drug product samples. It requires developing drug substance specifications that efficiently… more
- LA Care Health Plan (Los Angeles, CA)
- …The position will maintain a high level of based knowledge on benefits for all product lines (Medi-Cal, CMC , PASC, Healthy Kids and Covered California) as well ... performance in order to identify and optimize processes and support staff development , in partnership with the Quality Assurance Management. This position will… more