- Takeda Pharmaceuticals (Cambridge, MA)
- …analytical development, formulations development, and other CMC functions. + Develop and validation clinical and biomarker assays for all therapeutic areas. + ... access to modern medicines. This role will also support clinical /biomarker assay development and validation . For more...the relevant fields of CMC and/or assay development and validation . + Expert-level knowledge of data science… more
- Astellas Pharma (Westborough, MA)
- ** Manager , Quality Assurance Compliance** Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are ... range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease.… more
- AbbVie (Worcester, MA)
- …product introduction of clinical and commercial projects. Expectations that the QC Validation Manager will maintain high quality levels on all aspects of ... and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description Purpose Purpose The QC Validation Manager provides leadership and direction to the Quality Control… more
- Bristol Myers Squibb (Devens, MA)
- …cell therapy manufacturing. + Strong understanding of CSV (computer system validation ), data integrity, and regulatory requirements in laboratory environments. ... personal lives. Read more: careers.bms.com/working-with-us . **Position Summary:** The Senior Manager , Benchtop IT Systems at the Devens Cell Therapy Facility is… more
- J&J Family of Companies (Cambridge, MA)
- …discovery and development is required. + 7+ years of experience as a people manager is required. + Experience in clinical development with demonstrated expertise ... mechanisms, biomarkers, and novel targets. + Lead the development, validation , and regulatory engagement of digital tools and novel...in clinical research. 3. Experience with large-scale clinical datasets, EHR, and real-world data and… more
- ThermoFisher Scientific (Plainville, MA)
- …timely qualification of in-process and release testing of toxicological, clinical , and commercial grade biopharmaceuticals, qualification/ validation of ... rare, and otherwise untreatable diseases. **Discover Impactful Work:** The Manager , Quality Control Bioanalytical & Analytical Transfer provides leadership and… more
- Sumitomo Pharma (Boston, MA)
- …seeking a dynamic, highly motivated, and experienced individual for the position of ** Manager , Clinical Systems R&D IT Business Applications** who will serve as ... the primary liaison between R&D Clinical Operations team and IT, responsible for the delivery...Management, including the Software Development Lifecycle and Computer Systems Validation process + Excellent communication skills The base salary… more
- Bristol Myers Squibb (Devens, MA)
- …place than here at BMS with our Cell Therapy team. BMS is seeking a ** Manager of Cell Therapy Manufacturing** for a manufacturing facility in Devens, MA. The ... Manager will support the start-up and commercial licensure of...manner. + Complete documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records. +… more
- Bristol Myers Squibb (Devens, MA)
- …no better place than here at BMS with our Cell Therapy team. The ** Manager , Process Systems Engineer** provides input to the design and development for electronic ... to change management. + Works collaboratively with Manufacturing, Digital Plant, IT, Validation , Quality, and MSAT to ensure change initiatives are driven to closure… more
- Sumitomo Pharma (Boston, MA)
- …colleagues across the SMPA organization including, but not limited to, Clinical Development, Translational Medicine/Early Development, Regulatory Affairs, Data ... and ensure patient safety. + Assist in signal detection activities including data assembly, signal validation , and signal evaluation. + Perform literature… more