- Charles River Laboratories (Shrewsbury, MA)
- …responsibilities include serving as a Principal Investigator for the development and validation of biomarker, PK and ADA assays (eg: ligand binding assays, enzymatic ... This individual would be responsible for the composition and execution of validation and sample analysis protocols/plan in accordance with company standard operating… more
- Merck (Cambridge, MA)
- …leverage advanced computational modeling and simulation tools to support pharmaceutical reserachers in predicting drug behavior, improving descision-making, and ... discovery platforms. Collaborate with external vendors supporting target identification, validation , and pre-clinical/non-clinical development to evaluate opportunities, influence their… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- **About Us** Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: "Otsuka-people creating new products for better health ... develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for… more
- Cambrex High Point (Waltham, MA)
- …the transformation of research, development, and manufacturing across the pharmaceutical and fine chemical industries where organic chemistry underpins product ... campaigns. + Author and review process development reports, batch records, validation protocols, CMC documentation (eg, Module 3), and regulatory filings (IND,… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …robust and compliant manufacturing processes through effective technology transfer, validation , process monitoring, and lifecycle management. This individual will ... transfer activities to new or existing CDMOs. + Oversee the process validation lifecycle (PPQ, CPV, etc.) ensuring compliance with global regulatory standards. +… more
- AbbVie (Worcester, MA)
- …Analytical Development to support biologics DS process development, characterization, validation as well as GMP manufacturing investigation activities. Develop ... functions and CMC business partners. Oversee experimental execution, development, qualification, validation , and transfer of robust analytical methods for QC lab as… more
- AbbVie (Worcester, MA)
- …new product introductions. + Direct experience with system development and validation , including development of system specifications (DS, FS, URS) and risk-based ... validation strategies, and validation protocol development and...CFR Part 11 requirements for automated systems in the pharmaceutical or medical device industries. + Demonstrated problem solving… more
- Cognizant (Boston, MA)
- …developing, and supporting information systems in the Medical Device and pharmaceutical manufacturing industries Understand the paper Batch record and business ... studio Experience in C# and object-oriented programming concepts Author Computer System Validation (CSV) documents such as Functional Risk Assessment, Validation … more
- ThermoFisher Scientific (Boston, MA)
- …employee, to gain direct experience working onsite at a pharmaceutical / biopharmaceutical company, all while maintaining full-time benefits. **Key ... and/or review technical documents such as method development reports, method validation protocols and reports, and technical transfer documentation. + Engage CROs… more
- ThermoFisher Scientific (Plainville, MA)
- …testing of toxicological, clinical, and commercial grade biopharmaceuticals, qualification/ validation of analytical methods for support of cGMP manufacturing, ... and the transfer and validation of assay methods from clients and/or Assay Development...experience in a quality position within the biological and/or pharmaceutical industry required. + Significant experience in supporting functional… more