- Verista (Woburn, MA)
- …new skills and learn from our experiences to enhance our collective expertise Validation Lead (Laboratory) Analyst Responsibilities: + Perform validation ... from vendor manuals + Perform method transfers + Independently lead the Client through the Validation Lifecycle...+ Independently lead the Client through the Validation Lifecycle required for their identified equipment Requirements +… more
- Verista (Norwood, MA)
- …+ Perform Study on path forward of SDMS within Moderna CMC Quality testing Labs : + Driver to implement SDMS + Compliance on e-record audit trail, versioning, access ... control, archival & retrieval + Homogeneous Data output format via integration/parsing/upload + Security + Market and active providers of SDMS + Traditional SDMS & vendors + Market Majority: NuGenesis + LogiLab + Integration and Storage + Scitara, Zontal,… more
- Sanofi Group (Waltham, MA)
- **Job Title:** Vaccines - R and D Labs Business Product Owner **Location** : Waltham, MA **About the Job** The Vaccine R&D Data Catalyst team collaborates with ... position oversees all aspects of digital products for R&D labs (with a focus on mRNA CoE and GI),...Thunder. You'll also act as the Vaccine R&D Data Lead for your domain, maintaining data models and collaborating… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …programs through cross-functional collaboration. The candidate may also serve as a BST Lead for programs, leading execution of BST deliverables across a program and ... will support context of use-based biomarker development, fit-for-purpose assay validation , clinical feasibility assessments, and implementation strategies to deliver… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …programs through cross-functional collaboration. The candidate may also serve as a BST Lead for programs, leading the execution of BST deliverables across a program ... The candidate will support context-of-use-based biomarker development, fit-for-purpose assay validation , clinical feasibility assessments, and implementation strategies to deliver… more
- Sanofi Group (Framingham, MA)
- …and automation systems on the site. In this vital role they will lead the MBC, incorporating the latest digital advancements in alignment with Industry 4.0/Smart ... Systems & Automation (MS&A) Group is responsible for design, implementation, validation , support, and maintenance of Technology solutions in support of site… more
- Amgen (Cambridge, MA)
- …and testing sites. + May lead method transfer to CMO or contract testing labs + Review and approve protocols, reports from CMO and contract testing labs + ... analytical Chemistry, Manufacturing and Controls (CMC) sections in regulatory documents. + May lead and develop a small group of scientists. **What we expect of… more
- Takeda Pharmaceuticals (Lexington, MA)
- …equipment and software. + Manage and provide equipment/inventory management services to all R&D labs . + Establish, lead and manage team of full-time and contract ... software/hardware upgrades for existing equipment. + Identify opportunities and lead initiatives to collaboratively improve service levels and business processes… more
- The LEGO Group (Boston, MA)
- …looking for someone to coordinate the strategic sourcing of integrated circuits and lead the commercial aspects of our future sensor and interface components! You'll ... partner with our Creative Play Labs to build the future of the LEGO brand...Assessment concepts driving our target realization. + Own and lead resilience streams, managing the dependency of the LEGO… more
- AbbVie (Waltham, MA)
- …programs in early and late stage oncology clinical development. + Lead and coordinate resources from multiple functional areas (Biomarker research, Regulatory, ... area leads. + Oversee implementation of clinical trial assays at reference labs and centralized testing vendors. Monitors all changes in study scope ensuring… more
- ThermoFisher Scientific (Boston, MA)
- …company, all while maintaining full-time benefits. **Key** **responsibilities:** + Lead /support ALCM (analytical method lifecycle management) projects including late ... stage and post-marketing approve analytical activities such as method validation /verification and method transfer + Be accountable for the success of ALCM… more
- Danaher Corporation (Marlborough, MA)
- …possible. The Lab Manager II for Cytiva is responsible for management of our local labs and lab equipment , primarily to enable and optimize our verification and ... validation testing capabilities . The Lab Manag er II...for lab spaces . + Procurement and vendor management lead for lab supplies, test equipment, and 3rd party… more
- Globus Medical, Inc. (Methuen, MA)
- …Create various software test protocols to verify design and product requirements + Lead efforts to drive software testing of robotic, imaging and navigation systems ... Track Pro, and Jira + Experience with documentation and validation testing for FDA regulated industries, a plus +...commitment to delivering high-quality software + Ability to attend labs /surgeries + Ability to travel up to 5% of… more
- BAE Systems (Hudson, NH)
- …and grow. We are all about trust, camaraderie, and a shared ambition to lead the world in defense technologies and national security services. When you join our ... spanning the product lifecycle including design & development, verification & validation , transition to production, test equipment design and development, as well… more