- BeOne Medicines (Emeryville, CA)
- …have interactions with supporting functional areas such as CMC , Reg Strategy, Clinical/Non-Clinical, Quality/Manufacturing, GTS, Pharmacovigilance and Regulatory ... Compliance. This position will also play a key role in getting authoring teams within BeOne to adopt authoring in Veeva RIM and help to enable efficiencies therein. Provide leadership to Regulatory Submissions Operations Management teams (eg Regional… more
- Gilead Sciences, Inc. (Foster City, CA)
- …clinical labeling, distribution including cold chain, import/export, reverse logistics, CMC and GXP regulations . Possesses strong collaboration, influencing and ... negotiation skills to work effectively with internal cross-functional group and external suppliers to meet the aggressive clinical study timeline and patient needs. . Leads through ambiguity, can assess options quickly and efficiently implement the best option… more
- AECOM (Oakland, CA)
- …(SYSCOMs), Chief of Naval Operations (CNO), Commandant of the Marine Corps ( CMC ), Fleets, and other Navy and Marine Corps commands. + Provide executive-level ... support, including preparing senior leaders for public and congressional engagements + Support compliance with legislative and regulatory frameworks related to energy and water resilience initiatives. **DCS-Energy** AECOM's Energy practice provides a wide… more
- LA Care Health Plan (Los Angeles, CA)
- …(HRA) calls for Seniors and People with Disabilities (SPD) and Cal MediConnect ( CMC ) plus HIF for LA Care Medi-Cal Direct program (MCLA), call documentation and ... categorization, service authorization request and coverage determination , Appeals and Grievances across all lines of business). This position is responsible for the ongoing progression and maintenance of CSC's compliance program efforts, including, but not… more
- Gilead Sciences, Inc. (Foster City, CA)
- …+ Experience with analytical method development of biologic products in CMC (eg potency and/or process related impurities including host cell protein, ... host cell DNA, and affinity resin materials). + Hands on experience with or interest/aptitude to learn HPLC, MS, and Capillary Electrophoresis and other separation methods for protein analysis is a plus + Familiar with lab automation, data science and… more
- Kelly Services (Pleasanton, CA)
- …$175,000 - $200,000 annually **Overview** This client specializes in bioanalytical and CMC analytical services. In this role you will be responsible for the ... development, management, and continuous improvement of quality systems ensuring compliance with Good Laboratory Practice (GLP), Good Clinical Laboratory Practice (GCLP), and other applicable regulatory standards for our bioanalytical GLP lab. This role reports… more
- Deloitte (Costa Mesa, CA)
- …and generating submissions packages + Experience with submissions management, labeling, CMC change control and/or LCM processes + Understanding of emerging ... technologies, such as GenAI, and advanced data architectures is important. This includes multimodal data management, model design, Data Mesh, Data Fabric, and Data Products. + Ability to create critical collaterals for client workshops and customer interactive… more
- Amgen (Thousand Oaks, CA)
- …of scientific theory + Strong experience with regulatory requirements for API/Product ( CMC for IND/NDA, GLP/GMP, ICH) + Experience in authoring briefing books, ... investigational new drug applications, marketing authorization applications, and responses to regulatory questions + Well-recognized and established in the scientific community through a record of peer-reviewed publications and/or patents + Demonstrated… more
- Arup (San Francisco, CA)
- …and Revit MEP proficiency. + Familiarity with codes and standards, specifically CMC , OSHPD, IECC/ASHRAE 90.1, FGI/ASHRAE 170, LEED energy efficiency and indoor ... quality and NFPA. + Strong interpersonal and communication skills essential for team-based work. + Presentation skills with colleagues and clients of all levels and commercial/financial awareness. + The ability to prioritize effectively, balance assigned work… more
- RTX Corporation (Carlsbad, CA)
- …engine components. This role is on site at the Ceramic Matrix Composites ( CMC ) Center of Excellence. CMCs are an enabling material that increases the temperature ... capability of jet engine components. Through successful development and application of these materials, P&W will deliver engines that are more fuel efficient, lighter weight and more durable for commercial and military applications. + Partner with engineers to… more