- Novo Nordisk Inc. (Boulder, CO)
- About the Department The Boulder Site is home to the specialized technical operations /CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy ... analytical and process development, the CMC team works alongside Quality, Regulatory, Technical Operations and RNAi Early Development professionals at our… more
- Insmed Incorporated (Bridgewater, NJ)
- …Millennials™ lists.OverviewReporting to the Executive Director Quality GMP Compliance, the Director , Quality Operations will play a key role in managing QA ... drug manufacturing site QA head experience preferredAbility to drive functional, technical , and operational excellence. Ability to inspire and foster innovation,… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- … of Operations will report to the Executive Director of Operations and provide managerial, technical and quality leadership to the production ... operations . The incumbent will participate in strategic and technical planning for the Operations group, and will be responsible for establishing… more
- Merck & Co. (Rahway, NJ)
- …FLEx complex is shared across two co-leader roles, and includes operations that support end-to-end GMP clinical supply manufacture and product/process development, ... of the RY880 building.- The sterile portion of RY880 is in commissioning/qualification/ validation . Successfully delivering on the entire scope of FLEx, including the… more
- Insmed Incorporated (Bridgewater, NJ)
- …environment. No bench activities are expected from this role.Provide technical expertise on sample preparation, chromatography, mass spectrometric instrumentation, ... internal and external stakeholders (therapeutic areas, clinical pharmacology, clinical operations , non-clinical safety, contract research organizations etc.) to build… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position Summary The Director of Quality Operations provides direct support for all Manufacturing and Quality activities. This position supports the Quality ... Operations across multiple shifts to oversee all quality aspects...a Quality presence in warehouse, dispensing, and manufacturing areasSupport validation and qualification activities Perform Spot-Check Data Reviews Change… more
- Eisai, Inc (Nutley, NJ)
- …In addition, the incumbent will ensure quality is maintained in all aspects of technical work as well as manage performance and ensure adequate training and support ... analysis plans, programming of core economic models, model calibration, model validation , interpretation of model results and sensitivity analyses, protocol, … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …clinical study reports and regulatory submissions, as well as in-house validation of this work. Possesses in-depth knowledge of regulatory authority's ... other functional areas such as biostatistics, data management, clinical operations , pharmacovigilance, regulatory affairs, etc. Qualifications: Successful candidates will… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …functional teams consisting of internal customers such as Project Management, Site Operations , Validation , and Quality Assurance to properly identify design ... Position Summary The Engineering Director is directly responsible for leading the Engineering...to automation, process, capital projects, and equipment commissioning and validation . Key Responsibilities Develop strategy and lead the implementation… more
- Merck & Co. (Rahway, NJ)
- …the activities of programmers whose predominant accountability is the development, validation and execution of programs creating analysis datasets, tables, listings, ... partnerships with statistical stakeholders in BARDS LDS, EDS, CSS.Provide technical and/or scientific guidance to employees and colleagues.Manage staff resources… more
- Merck & Co. (Durham, NC)
- …initiatives on an as-needed basis.Initiate and lead collaboration within the Operations , Quality, and Technical organizations to resolve complex problems.Uses ... technical documentation. Initiate and lead collaboration within the Operations , Quality and Technical organizations to resolve complex problems.… more
- Aequor (Seattle, WA)
- …of Document Control & Reporting Experience, Veeva experience preferred Technical troubleshooting Self motivated, independent, great communication Experience working ... Document Control (QADC) Associate Specialist supports the cGMP Document Control operations for the Client Cell Therapy Above-site organization, including the… more
- Quarterra (TX)
- …and working relationships with a wide range of corporate personnel, including technical operations , management, and executives as well as internal audit ... amenities. For additional information, please visit Quarterra.com. Summary of Position: The Director , Governance, Risk & Compliance will be at the forefront of… more
- eXcell (Seattle, WA)
- …to complex institutional data. This role will be responsible for technical development and deployment end-to-end analytical lifecycles. The Data Scientist will ... Cycle: Model Design: Translate business requirements and stakeholder requests into technical requirements Evaluate technical requirements to identify data… more
- Northeast Georgia Health System, Inc (Gainesville, GA)
- …capacity demand analysis and release planningManagement experience over a highly technical and productive reporting business analyst and data analyst teamsStrong ... to manage data and IT systems, oversee implementation and operations of IT projects, and manage agency and internal...methodology and roll out Epic Slicer Dicer data models.Assists Director of Data and Analytics with policies and procedures… more
- Northeast Georgia Health System, Inc (Gainesville, GA)
- …to lead strategic planning to manage data and IT systems, oversee implementation and operations of IT projects, and manage agency and internal IT resources. Be able ... development, and project management of end-to-end enterprise analytics solutions. Assists Director of Data and Analytics with policies and procedures related to… more
- RML Specialty Hospital (Chicago, IL)
- …pay period) + Benefit-eligibleFTE: 0.9Req. Number: 1039Reporting to the Nursing Director or Manager and according to the established policies, procedures, nursing ... is not resolved, nurse refers question to Clinical Supervisor, Nursing Director /Manager or Chief Nursing Officer as necessary for resolution.Maintains the basic… more
- Bristol Myers Squibb (Devens, MA)
- …at BMS with our Cell Therapy team. **Position Summary** The Director of Validation , Cell Therapy Technical Operations reports to the Executive ... Director , Drug Product Cell Therapy Technical Operations within the Cell Therapy Development...cell therapy. + Create, maintain, deploy global cell therapy validation technical standards via quality system. +… more
- embecta (Andover, MA)
- …projects, for complex electromechanical medical devices. Reporting up to the Associate Director , R&D - Verification and Validation , the successful candidate ... , Quality, and IT/Infrastructure groups to achieve design verification and validation deliverables. + Drafts engineering technical reports, test method… more
- BeiGene (Hopewell, NJ)
- **_General Description:_** The Associate Director Site Technical Services is responsible for the day-to-day activities of the Validation team, Metrology, ... Works to ensure the efficient and effective day to day operations of the validation area. Ensures the Validation function supports operational needs… more
