- Takeda Pharmaceuticals (Boston, MA)
- …career? If so, be empowered to take charge of your future at Takeda. Join us a Manager , Clinical Data Validation Engineer in our Cambridge, MA office. At ... and oversight of clinical trial deliverables. As part of CDE, the Clinical Data Validation Engineer (DVE) group leads validation and reconciliation… more
- Bristol Myers Squibb (Devens, MA)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . **Position:** Manager , Cleaning Validation , Validation Engineering **Location** : ... **Position Summary** **Manage the development and maintenance of the cleaning validation and changeover cleaning verification program elements for a fully automated,… more
- Harvard University (Cambridge, MA)
- …officers, protocol specialists and database managers + Experience with independently analyzing data from clinical trials using standard statistical techniques + ... Working with project leadership on assignment of work (eg, validation , data requests, studies) to MS-level Biostatisticians...other infections). Duties include, but are not limited to, clinical trial and observational study review; data … more
- Prime Therapeutics (Boston, MA)
- …results, and implements controls to monitor consistent use of the solution. + Data Validation : Performs the technical and administrative functions to lead the ... and drives every decision we make. **Job Posting Title** Manager , Operations (Remote) **Job Description** + Operations: Manages team...Benefit Analysts in organizational data validation projects to support major system… more
- Harvard University (Cambridge, MA)
- …officers, protocol specialists and database managers + Experience with independently analyzing data from clinical trials using standard statistical techniques + ... leadership on: + Assignment of work (protocols, ancillary studies, data and specimen requests, validation , etc.) to... trials and observational studies, and as statistical project manager for IMPAACT's clinical trials involving regulatory… more
- Sumitomo Pharma (Boston, MA)
- …and suppliers of drug substances and drug products used for investigational clinical trials and/or commercial phases. The Senior Manager ensures compliance ... us on LinkedIn (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=2504638834&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fsumitomo-pharma-america%2F&a=LinkedIn) . **Job Overview** The Senior Manager of GMP Quality Control oversees GMP compliance of… more
- Takeda Pharmaceuticals (Boston, MA)
- … Pharmacology, Clinical Operations, Procurement, R&D and IT Quality, and Clinical Data Solutions to support clinical bioanalytical and biomarker ... scientific operations and logistics with external vendors thereby helping create high quality clinical data . **How you will** **contribute:** + The scientific … more
- Nanobiosym, Inc. (Cambridge, MA)
- …business and regulatory expectations. * Ensure the timely and compliant generation of clinical and validation data required to support regulatory submissions ... Testing CLIA LAB. The role and requirements are below. The CLIA ( Clinical Laboratory Improvement Amendments) Quality Manager will provide quality and… more
- ThermoFisher Scientific (Plainville, MA)
- …timely qualification of in-process and release testing of toxicological, clinical , and commercial grade biopharmaceuticals, qualification/ validation of ... otherwise untreatable diseases **How will you make an impact?** The Manager , Quality Control BioAnalytical provides leadership and scientific and technical expertise… more
- Bristol Myers Squibb (Devens, MA)
- …Bristol Myers Squibb is seeking a highly skilled and experienced Senior Manager for our Manufacturing Execution Systems (MES) team. The successful candidate will ... manufacturing sites. This role is critical in driving operational excellence, ensuring data integrity, and supporting our mission to deliver innovative medicines to… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …submit expedited reports to regulatory authorities and business partners and conduct validation testing of data migrations and safety upgrades; coordinate ... LOCATION:** Cambridge, MA **POSITION** : Pharmacovigilance (PV) Systems Operations Manager - GPSE **POSITION DESCRIPTION:** Takeda Development Center Americas, Inc.… more
- ThermoFisher Scientific (Plainville, MA)
- …skills to join our growing Process Development team. **Job Title: Manager - Upstream Process Development - Gene Therapy** **Location/Division Specific Information** ... characterization, scale up of gene therapy molecules from pre clinical to clinical and commercial phase. As...junior team members. + Collaborate with clients, ensures accurate data and presentations to presented clients. + Collaborate with… more
- Bristol Myers Squibb (Devens, MA)
- …Support and coordinate site startup and commissioning and support validation activities for specified equipment. Oversee distribution system for compressed ... Devens campus: + Biologics Large Scale Commercial Manufacturing + Biologics Clinical Manufacturing + Biologics Cell Bank Manufacturing + Biologics Development and… more
- Bio-Techne (Waltham, MA)
- …to perform high complexity molecular biology procedures under the direction of the Clinical Operations Manager and Laboratory Director + Follow the laboratory's ... and positive purpose of enabling cutting-edge research in Life Sciences and Clinical Diagnostics. Bio-Techne, and all of its brands, provides tools for researchers… more
- Sanofi Group (Cambridge, MA)
- …strategy in consistency with the planned statistical analysis and is involved in study data validation and review processes, support the CRD for the Clinical ... of the data and investigations of safety cases with the Clinical Trial Team (Monitoring Teams) or Pharmacovigilance. **Main Responsibilities** + Contributes to… more
- MetaOption, LLC (Cambridge, MA)
- …Manufacturing, Design for Manufacturing (DFM), SolidWorks Proficiency:, Process Validation , New Product Development, Statistical Analysis Software, Vendor Management ... Work Hours Per Day: 7 Note : The hiring manager is specifically seeking candidates with hands-on experience in...by Management. * Review engineering product specifications and CAD data /drawings as part of the design review process to… more
- Bristol Myers Squibb (Devens, MA)
- …Engineer I will be part of the Commissioning team reporting to Sr. Manager , Commissioning Engineering and support clinical and commercial Devens manufacturing ... Quality Assurance, Quality Control, Qualification, Manufacturing Engineering, Facilities operations/maintenance, Validation and Manufacturing. **Key Responsibilities:** + Executes and/or Leads… more
- Naven Health (Worcester, MA)
- …always.** Naven Health is a nationwide home infusion nursing network and clinical platform focused on delivering specialized, truly exceptional infusion care. With ... services for a broad range of specialized therapies, as well as clinical trial services and special programs for pharmaceutical manufacturers. Joining the Naven… more
- Olympus Corporation of the Americas (Westborough, MA)
- …Control activities for new product development efforts. + Support Process/Design Validation Nerification activities and approach including software validation . + ... Lead implementing limited cost of quality concepts, including cost of quality, data collection, & reporting. + Support Manufacturing Engineering in the creation of… more
- Bristol Myers Squibb (Devens, MA)
- …addition to the Process Automation Systems (PAS) for our Large Scale and Clinical Manufacturing Suites, and our Biologics Development organization at the BMS Devens ... software. + A minimum of 4 years in a manager role with a history of hiring, developing and...similar), Manufacturing Execution Systems (Syncade or similar), EBR and data historian tools (PI or similar). + Demonstrated understanding… more