- Bristol Myers Squibb (Devens, MA)
- …and Standard Operating Procedures. + Knowledge of regulatory validation requirements including FDA , EMA and all other Worldwide Regulatory requirements (ICH Q7, Q8, ... and Q9) particularly as it applies to biologics manufacturing. + Proven ability working in a matrix environment and leading multi-level / cross-functional teams to achieve the highest performance in meeting site and departmental objectives. If you come across… more
- Boehringer Ingelheim (Indianapolis, IN)
- …+ Performs all Company business in accordance with all regulations (eg, EEO, FDA , etc.) and Company policy and procedures. When violations are noted/observed they ... are to be immediately reported to management. Demonstrates high ethical and professional standards with all business contacts in order to maintain BIAH's excellent reputation within the animal health community and internally. **Requirements** Sales… more
- Tufts Medicine (Boston, MA)
- …familiarity with blood banking and cellular therapy regulatory requirements (ie AABB/CAP, FDA , FACT). + Committed to teaching and clinical service + Licensed and/or ... eligible to practice Medicine in the Commonwealth of Massachusetts + Qualify for a faculty appointment at Tufts University School of Medicine and participate in resident and medical student teaching + A portfolio of clinical research activities and/or funded… more
- HCA Healthcare (Houston, TX)
- …customer service skills. This individual will ensure the lab upholds CAP, CLIA, FDA , OSHA, AABB standards, and any other pertinent regulatory requirements for their ... section as they foster a safety culture. As needed they will evaluate personnel utilizing job descriptions and evaluations developed for those personnel. + Leadership - Manages operations for best outcomes. + Integrity - responsible to the right thing in the… more
- University of Maryland, Baltimore (Baltimore, MD)
- …Center to capitalize on pioneering innovation * Contemplate and develop partnerships with FDA in the planning phase of cancer pragmatic trials to maximize the ... potential relevance of our results on governmental policy and/or clinical practice * Expand existing and develop new partnerships between the University of Maryland and Community Leaders in West Baltimore and other regions of Maryland to maximize participation… more
- Bristol Myers Squibb (Bothell, WA)
- …principles." + Experience working in biopharma, cell therapy, Good Manufacturing Practices, FDA regulated, or other regulated environments is a plus." + Proficient ... in Microsoft Outlook, Teams, Project, Excel, SharePoint, and PowerPoint. Smartsheet is beneficial." + Experience applying predictive/waterfall project management processes and methodologies." + Self-starter who can drive small to mid-sized projects forward… more
- BeOne Medicines (Pennington, NJ)
- …drug preclinical, clinical and commercial requirements. + Familiarity with EMA and FDA regulatory requirements. + Effective communication, oral and written, in a ... multi-disciplinary, project-driven work environment. **Supervisory Responsibilities:** + Strategic and tactical planning with ability to convey business relevance to team + Ability to translate strategy into actionable goals and expectations for team members +… more
- HCA Healthcare (West Haven, UT)
- …with standards set forth by accrediting agencies: CAP, JCAHO, CLIA, FDA and CMS. Leads department accreditation preparation. + Oversees quality control/assurance ... programs related to test methodology, protocols, equipment and supplies. Actively participates in Continuous Quality Improvement. + Provides input into the design of workflows, systems and processes and implements corrective action plans for service/quality… more
- Reckitt (Wanamingo, MN)
- …protocols and reports to qualify manufacturing and cleaning processes. + Interacts with FDA when onsite for audit as a subject matter expert. + Leverages knowledge ... of unit operations and engineering principles to effectively troubleshoot processing and equipment issues. + Use business tools to investigate out of specification issues and recommend disposition of material. + Assess and implement improvements for Plant CIP… more
- Bristol Myers Squibb (Devens, MA)
- …cryogenic storage (LN2) is preferred + Experience with health authorities (ie, FDA ) for audit support + Experience and familiarity with electronic systems including ... SAP, and manufacturing execution systems (MES) including Syncade and DeltaV + Safety and Quality mindset; proven ability to build a culture around these values and to communicate critical information clearly and in a timely manner to team and to manager as… more