- Regeneron Pharmaceuticals (Cambridge, MA)
- …a typical day might include the following:** + Supporting all manufacturing and QC equipment within RCM's 30,000 SF Phase 1 clinical manufacturing facility + ... to manufacturing deviations and anomalies associated with automation systems and control system software + Support engineering and validation projects as well… more
- US Tech Solutions (Worcester, MA)
- …analysis utilizing hybrid manual and automated systems to generate high quality bioanalytical data. Reporting results to project teams which enable Pharmacokinetic ... report writing and day-to-day lab operations. * Sample management and sample data QC in LIMS. * Write, and update experimental protocols and procedures. * Initiate,… more
- Takeda Pharmaceuticals (Boston, MA)
- …quality delivery of data science projects by implementing robust methodologies, quality control measures, and continuous improvement of data governance ... (RWE), and regulatory databases (eg, FDA), utilizing SQL and performing version control and cloud-based deployment on platforms like AWS; demonstrate expertise with … more
- Guidehouse (Boston, MA)
- …multiple projects simultaneously of all varying sizes and durations to ensure quality control and key client's perceived value while supervising, mentoring ... team provides program design, implementation, and monitoring services to pharmaceutical , biotechnology, and medical device, companies. We support our clients… more
- Cytel (Cambridge, MA)
- …External Data Sources + Clinical Coding + SAE Reconciliation + Data Validation and Quality Control + Blinding and Unblinding Procedures + Database Lock and ... systems can achieve. **Sponsor-dedicated:** Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be… more
- System One (Devens, MA)
- …in compliance with FDA cGMPs, DEA regulations, and company SOPs + Partner with Quality Control , Quality Assurance, Maintenance, and Materials to troubleshoot ... Type: Direct Hire Overview Our client, a leading API pharmaceutical manufacturer, is seeking two Production Leads to join...their full potential + Lead daily operations, ensuring product quality and safety while meeting output targets. + Organize… more
- Astellas Pharma (Cambridge, MA)
- …and maintenance of medical science specific global standards, processes, SOPs, training and quality control , to the highest level of compliance with ICH, GCP ... you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries...of the Oncology Solid Tumor Development team. Accountable for quality in all work products of the team, ensuring… more
- Charles River Laboratories (Shrewsbury, MA)
- …of In-life Operations, Formulations, Necropsy, Histology, Sample Processing, Clinical Pathology, Quality Control , Training and Archives. Responsible for the ... financial aspect, in collaboration with Finances and the Managerial staff, for the control of expenses to meet the company budget. Incumbent will optimize resource… more
- Takeda Pharmaceuticals (Lexington, MA)
- …technical assessments and risk analyses to inform program strategies. + Drive quality control and regulatory strategies for late-stage development, including ... to ensure analytical methods and strategies meet scientific, regulatory, and quality standards necessary for regulatory filings, commercial readiness, and lifecycle… more
- Takeda Pharmaceuticals (Boston, MA)
- …to the study, organize and prioritize programming activities including production and quality control of datasets and outputs while following internal standard ... related experience. Prior experience must include: Program analysis programs and quality control checks of analysis datasets, dataset specifications, statistical… more