- Rigel Pharmaceuticals Inc. (San Francisco, CA)
- The Senior Manager, GMP Quality Operations, is responsible for overseeing day‑to‑day GMP Quality Assurance operations at Rigel and across contracted ... and testing activities at contract organizations are performed in compliance with cGMP standards. Lead Rigel Quality Event program to ensure effective… more
- Meissner Filtration Products, Inc. (Camarillo, CA)
- …with friends or connect with us on LinkedIn! Are you a highly skilled Senior Automation / Controls Engineer with a passion for designing and developing innovative ... manufacturing processes? Our industry-leading company is seeking a motivated and experienced Senior Automation / Controls Engineer to join our team and help us… more
- Cresilon, Inc (New York, NY)
- …and execute test methods to aid in exploratory research, product development, and quality control ; conduct chemical and mechanical property evaluation tests to ... and submit invention disclosures. Ensure that all design activities adhere to FDA Quality System Regulations and ISO 13485 design control and risk management… more
- Genentech (San Francisco, CA)
- The Position We are seeking a strategic and visionary Senior Manager, Facilities Data & Analytics to build and lead the data foundation for our Facilities & ... a robust data governance framework for 30,000+ assets, ensuring data quality , consistency, and accessibility across our asset management platform. Ensure processes… more
- Gilead Sciences, Inc. (Foster City, CA)
- Senior Director-Biologics Analytical Development (Pivotal and Commercial) United States - California - Foster City Process/Product Development & Operations Regular ... fulfil their aspirations. Join Gilead and help create possible, together. Senior Director in Biologics Analytical Development (Pivotal and Commercial) Foster City,… more
- Northern Impact (Sacramento, CA)
- …firms specializing in life sciences, education, and workplace is actively seeking a Senior Project Manager to join their San Francisco, Mountain View or Sacramento ... master planning, building, and interior design services, including laboratory, cGMP , and medical planning, to new and established companies, institutions,… more
- Gilead Sciences, Inc. (Foster City, CA)
- Senior Director, PDM Product Strategy Leader United States - California - Foster City Process/Product Development & Operations Regular Gilead Sciences, Inc. is a ... packages from FIH through commercialization. Identify process, analytical development, and control system risks - then develop mitigation plans and enable effective… more
- MSD Malaysia (Rahway, NJ)
- …Training, and SOPs for all GxP automation systems.* Lead integration of control systems with MES, Quality , and Batch Reporting applications.* Understand ... and qualification needs.* Execute and develop appropriate system validation, change control , and testing documentation in partnership with project CQV and IT… more
- Cresilon, Inc (New York, NY)
- …towards FDA/regulated authority submissions, Act as research liaison between R&D and Quality Control to define product specifications. Maintain active dialogue ... for use in medical devices, ensuring all activities meet quality and regulatory standards. This role involves providing expertise...of robust, innovative materials and products. This is a senior technical role overseeing a small team. The R&D… more
- Gilead Sciences, Inc. (Foster City, CA)
- …mechanical systems. Review, improve, and interpret engineering drawings, specifications, control sequences, P&IDs, and equipment submittals. Develop, implement, and ... maintain programs and processes to ensure high‑ quality design and operations, and compliance with CBC, CFC, CMC, cGMPs, GEPs, and GLPs. Collaborate with Maintenance… more
- Gilead Sciences, Inc. (Foster City, CA)
- …alignment of near-term deliverables and long-range plans with respect to analytical control strategies and regulatory strategies for drug substance and drug product ... quality attributes across all PDM functions Oversee analytical method...review of relevant PDM project reviews Serve as a senior member of the Technical Development Leadership Team responsible… more
- Pfizer, SA de CV (TX)
- …variety of cross-functional areas, including support of production planning and control , total quality management, systems, manufacturing, equipment and ... facilities engineering, material management, and process reengineering. As a Senior Associate, your knowledge and skills will contribute towards the goals and… more
- MSD Malaysia (Rahway, NJ)
- …combination product/medical device and healthcare regulations, including FDA combination products cGMP , Quality System Regulation, FDA Human Factors guidance, ... * Lead/Support continuous improvement initiatives for design control and risk management processes* Identify and eliminate process inefficiencies using operational… more
- Novo Construction Inc (San Francisco, CA)
- …managing projects across the Bay Area, overseeing project schedules, ensuring quality control , and facilitating communication among key stakeholders, including ... office personnel Review and prepare owner billings on a monthly basis Cost Control Identify, track and manage scope and change orders both Owner/Client and… more
- Curium Pharma (Des Moines, IA)
- …our commitment to securing a brighter future for all those we serve: An enhanced quality of care for our patients. A trusted partner to our customers. A supportive ... with corporate goals across multiple sites while managing P&L, cost control , and overall financial performance Optimizes manufacturing and supply chain efficiency… more
- Gilead Sciences, Inc. (Foster City, CA)
- …project management tools and techniques. Ability to interact effectively with senior management and construct compelling business cases to justify project ... OR PhD and Two Years' Experience Experience in pharmaceutical operations/ cGMP environment highly desirable. Excellent knowledge of logistics operations within… more
- University of Southern California (Los Angeles, CA)
- …gene therapy of internal/external users in the university's current Good Manufacturing Practices ( cGMP ) facility. The Quality Control (QC) Specialist is ... Supports cGMP manufacturing operations with responsibility for quality control . Performs cGMP batch...cGMP guidelines and using aseptic techniques. Works with senior staff to ensure facilities' compliance with all applicable… more
- University of Southern California (Los Angeles, CA)
- …assay development and qualification for product testing. + Lead technology transfer to cGMP manufacturing and quality control , ensuring efficient scaling and ... workflows and eliminate inefficiencies. Establishes metrics and reports on the state of cGMP operations to senior management. + Participates in vendor management… more
- Gilead Sciences, Inc. (Foster City, CA)
- …role for the success of Clinical and Commercial Biologics and Small Molecule Quality Control . This individual provides support for strategic leadership and ... logistics and data entry from CTLs/CMOs into Gilead's LIMS. **Department:** Global Quality Control - GQC-Biologics and Small Molecules **Job Responsibilities: **… more
- ThermoFisher Scientific (Boston, MA)
- …Practices (GMP) Safety Standards **Job Description** **Sr. Scientist - FSP - Quality Control ** Shift: Full-Time; Monday - Friday; 8am-5pm EST **ONSITE:** ... digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities… more
