- FUJIFILM Holdings America Corporation (College Station, TX)
- …templates, documentation, and files.Supports regulatory and client audits as CSV subject matter expert .Perform other duties as assigned.Qualifications: ... representing a source of pride for the area.The Senior Computerized Systems Validation Engineer, under general direction, will be responsible for oversight of all… more
- Eisai, Inc (Nutley, NJ)
- …development of action plans. Build training documents to ensure optimal use of tools.As " Subject Matter Expert " this position interprets key business reports ... from you.JOB SUMMARY:As a member of the Data Analytics group, the Associate Director , Commercial Analytics is part of a high performing team that provides… more
- Aequor (Seattle, WA)
- …needs/gaps to ensure a smooth cross-site material transfer process . Serve as a subject matter expert ( SME ) for cross-site material transfer ... Business System Analyst Operational Support will work alongside the Global Business Process Owner (BPO) for Cell Therapy Warehouse & Inventory Management, to support… more
- Bristol Myers Squibb (Seattle, WA)
- …by providing oversight of all the validation activities, including providing SME assessment for proposed process life-cycle changes. The lead will serve ... BMS with our Cell Therapy team. **Position Summary** The Director of Validation , Cell Therapy Technical Operations...process , equipment, and facilities, in collaboration with the validation and technical SME network. + Serve… more
- Bristol Myers Squibb (Bothell, WA)
- …21CFR Part 11, , EU GMP Annex 1 principles. + Acts as a validation Subject Matter Expert ( SME ) providing support to multi-function teams, advises ... processes and environmental control systems. The Senior Engineer I, Validation supports airflow visualization study (AVS), aseptic process... lifecycle information management system + Serve as a subject matter expert for aseptic… more
- Astellas Pharma (Westborough, MA)
- …records on time and support audits and inspections of the manufacturing areas; act as subject matter expert ( SME ) for manufacturing operations + Join ... of staff. After the startup of manufacturing operations, the Director , Manufacturing will be responsible for executing process...to include yet not limited to: Operational Readiness; MSAT, Process Engineering; Validation ; QC; Supply Chain &… more
- Bristol Myers Squibb (Devens, MA)
- …safety and BMS values behaviors and attitudes, thereby shaping the culture + Acts as subject matter expert on behalf of team during audits and inspections ... Facility, including commissioning, qualification, and validation (CQV), computer systems validation (CSV), process validation , and change control. **Key… more
- Lilly (Indianapolis, IN)
- …team in meeting organizational goals through establishment and reporting of metrics. + Act as subject matter expert to peers, colleagues, and staff + Ensure ... of Eli Lilly and Company. **Position Summary:** The Associate Director of Quality Engineering and Computer System Validation...to request an accommodation as part of the application process . Any other correspondence will not receive a response.… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and execution across the product lifecycle, from discovery to post marketing. Provides signal management subject matter expert ( SME ) support to the PS TA ... PV or other audits and inspections. Is Gilead's signal management/signal detection SME , go-to person regarding process , systems, regulations, and best practices.… more
- Teva Pharmaceuticals (West Chester, PA)
- …protocols and bioanalytical study reports + Serves as project representative and technical subject matter expert on biomarker analysis + Interacts with ... Associate Director - Biomarker and Metabolism Analytics Date: Apr... with strong experience in biomarker method development and qualification/ validation in support of preclinical and clinical studies for… more
- Lilly (Indianapolis, IN)
- …making medicine and creating real-world solutions. **Key Objectives/Deliverables:** + Become Network Subject Matter Expert in oligonucleotide API synthesis ... technical depth of understanding of unit operations, technical transfers and process validation strategy. This position requires comprehensive knowledge of… more
- Scripps Health (San Diego, CA)
- …patient care, teaching, research and optimizing management of resources. . Serves as a coding subject matter expert for the system, serving on an array of ... open to change, go ahead and unlock your potential. Join Scripps asSenior Director , Revenue Cycle where you will have primary accountability for the oversight of… more
- Quad (Chicago, IL)
- …requests (RPI / RFP), client presentations, investor questions and surveys. + Serve as subject matter expert in sustainability: + Collaborate with other ... believes we can always create a better way. The Director of Sustainability Reporting plays a critical role in... Validation : + Coordinate efforts in collaboration with subject matter experts to collect, verify, and… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Sr Director , Global IT Quality Compliance Date: Apr 26,...Integrity guidance + Fulfill the role of CSV/Data Integrity subject matter expert and ensure ... system quality for the serialization and aggregation programs + Afford CSV Quality subject matter expertise and consultative services to the various Teva… more
- Tecomet (Woburn, MA)
- …leading manufacturing or product development team **KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED** + Subject matter expert in Automation and Robotics. Macro ... ** Director , Advanced Manufacturing Technology** **Build innovative solutions and...new product and process development (NPPD) and validation (PPAP, PFMEA/DFMEA, etc.). + Expert level… more
- J&J Family of Companies (Lexington, MA)
- …of those solutions into existing processes. Act as subject matter expert within the device development process setting expectations at each stage and ... Engineering Director , Devices - 2406181206W **Description** Johnson & Johnson...of devices in accordance with the combination product development process (CPDP). Partner closely with Discovery colleagues within DPDS… more
- Bristol Myers Squibb (Princeton, NJ)
- …functions to facilitate methods, data, and model development and application + Serve as a subject matter expert to both internal colleagues and the external ... and clinical development. Mechanistic model and data characterization, calibration, and validation are critical aspects of QSP&PBPK modeling approaches needed during… more
- Bristol Myers Squibb (Seattle, WA)
- …applying external knowledge to internal research programs as appropriate and acts as a subject - matter expert within the team to critically evaluate the ... BMS' current and future therapeutics. Reporting to Senior Scientific Director Translational Medicine, the TM Associate Director ...Skills:** * Contributing to research program and business. * Subject matter leader. * Broad knowledge of… more
- Integra LifeSciences (Princeton, NJ)
- …in a continuous improvement, operations and/or supply chain leadership role._ + _Subject Matter Expert in Lean Six Sigma and various continuous improvement ... of DOEs, validation studies and establishing statistical sampling plans for process controls._ + _Proven experience in product, process analysis and… more
- Sanofi Group (Framingham, MA)
- …upstream process development and oversee their professional development + Serve as a subject matter expert in Cell Culture Development and support the ... process to our commercial facilities. Commercialization responsibilities also include process characterization, validation , and IND/BLA authorship. The role… more
