- Roche (South 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)
- …help create possible, together. **Job Description** **Key Responsibilities** Senior Manager, Global External Manufacturing Biologics supports uninterrupted supply ... global external contract manufacturing network, while ensuring compliance with cGMP , regulatory requirements, and environmental, health, and safety legislations.… more
- Integra LifeSciences (Princeton, NJ)
- …closely with quality assurance and production teams to integrate endotoxin control practices within broader quality systems and manufacturing processes. + ... **SUMMARY** We are seeking a highly skilled and motivated Senior Process Engineer II with a focus on bacterial...bacterial endotoxin testing programs, an understanding of medical device quality systems, and a commitment to ensuring product safety… more
- J&J Family of Companies (Spring House, PA)
- …that is positively impacting patients' lives by growing and scaling our high quality cell and gene therapy products? Apply today for this exciting opportunity to ... facility design, process qualification/comparability campaigns, process risk assessments, process control strategies and new process training. . Shape facility… more
- J&J Family of Companies (Raritan, NJ)
- …at https://www.jnj.com/innovative-medicine We are searching for the best talent for a ** Senior Scientist, External Manufacturing MS&T (CAR-T)** to be in Raritan, NJ. ... **Purpose:** The Senior Scientist, External Manufacturing MS&T (CAR-T) supports manufacturing activities...in the virtual plant team and actively collaborates with Quality , Supply Chain, and Growth & Partnerships functions. **You… more
- Genentech (South San Francisco, CA)
- …single day, continuously improving what it does. Global Analytical Development and Quality Control (ADQC) organization is a leader in developing, validating, ... Senior Principal Scientist position is available in Genentech's Analytical Development and Quality Control (ADQC) department for US Biologics in the Pharma… more
- PACIV (Indianapolis, IN)
- …Collaborate with the Validation Team to ensure automation systems align with regulatory and quality standards by applying expertise in cGMP , GAMP, and 21 CFR ... We are looking for a Senior DeltaV Automation Engineer for our Indianapolis, IN...combines strategic technical leadership with hands-on implementation of industrial control systems. Support proposal development, lead automation projects, and… more
- Genentech (Oceanside, CA)
- …pharmaceutical drug substance facility. The site employs highly integrated computer control systems to manage plant operations and manufacturing data. The candidate ... the local IT OT Team. + Ensure adherence to cGMP , GSP 111, and CSV 6 requirements across all...meet the defined timelines without extensions. + Manage IT quality topics such as change management process. + Manage/lead… more
- Endo International (Rochester, MI)
- …biotech industry, with at least five years in a senior leadership or site quality head role. + Deep expertise in ** cGMP , FDA 21 CFR Parts 210/211, ICH ... timely CAPA implementation. Oversee supplier and contractor qualification, audits, and quality agreements. Ensure robust document control , data integrity, and… more
- Edgewell Personal Care (Sidney, OH)
- …time. + Travel Requirements: + Infrequent Travel. + Key Relationships: + Senior Process Engineer. + Operations, Quality , Engineering, Maintenance & Planning, ... through identification of the key critical parameters and then working to control and reduce the variation. Purpose includes leading, supporting and improving key… more