- Fujifilm (College Station, TX)
- …of PD & CSO proposals to incorporate the latest technological advances in the biologics field to FLB workflows. . Responsible for taking a leadership role in the ... day-to-day operations of projects, able to handle multiple priorities quickly and efficiently including conducting and evaluating training for new or current team members and delagating tasks appropriately. . All other duties as may be assigned. **Required… more
- Alloy Therapeutics (Waltham, MA)
- …capabilities that are foundational for discovering and developing therapeutic biologics . The company facilitates affordable, non-exclusive access to the entire ... drug discovery community from academic scientists, small and medium biotech, to the largest biopharma. At Alloy, we believe our industry should compete on getting the best drugs to patients as quickly as possible, not exclusive access to the best platforms. As… more
- ThermoFisher Scientific (Waltham, MA)
- …paired with our hardware and controls enabling our customers to drive faster biologics development, reduce time to market and implement more efficient and flexible ... manufacturing. As the Service Leader in the BioProcess Equipment and Automation (BEA) business unit within SUD, you will provide strategic leadership to optimize and expand service offerings to our global customer base. This role will lead service operations… more
- DRT Strategies, Inc. (Silver Spring, MD)
- …supports the FDA's mission to ensure that safe and effective drugs and biologics are available to the American people. Job Summary: The Clinical Research Studies ... SME will provide administrative support for applied regulatory science research and operational activities in FDA. In addition, the SME will provide specialized expertise to improve business and knowledge management processes as well as other operational… more
- Novo Nordisk (Bloomington, IN)
- …combine and interpret data from multiple disciplines and an understanding of the full Biologics process with respect to specific area of expertise + Begin to provide ... reliable and defendable interpretations of regulatory guidance for the customer + Well organized with ability to handle and direct multiple activities within the group simultaneously + Maintains staff by recruiting and hiring, employees, developing personnel… more
- CommonSpirit Health (Santa Maria, CA)
- …and aliquoting specimens, and ship specimens in accordance with federal biologics shipping regulations. + Identify and report all unanticipated and other ... adverse/serious adverse events, as well as protocol deviations, violations or exceptions, to the study sponsor and IRB as required by GCP, FDA, OHRP and CommonSpirit Health policy. + In conjunction with the PI and other facility/clinic staff, may provide… more
- Lilly (San Diego, CA)
- …+ 4+ years of experience (academic or industry) in computational antibody discovery, biologics R&D, or related field. **Preferred** : + Proven expertise in NGS-based ... antibody repertoire sequencing and analysis. + Proficiency in Python, deep learning frameworks, and bioinformatics pipeline development. + Experience designing and managing large-scale computational infrastructure (on-premises and cloud-based). + Demonstrated… more
- Astellas Pharma (Cambridge, MA)
- …therapies in Oncology, or modality platforms such as ADCs, engineered biologics , or engineered small molecules. + Expertise in competitive portfolio landscapes ... in oncology therapeutic area. + Deep understanding of advancements in drug discovery, emerging technologies, and industry trends, and apply this knowledge to enhance research strategies. + Proven ability to integrate complex data sources into cohesive strategy… more
- Abbott (Alameda, CA)
- …years' experience working with Class II, Class III medical devices and/or biologics /drugs. Regulatory Affairs Certification (RAC) is a plus. . Experience with 510(k) ... applications, PMA supplements, US device regulations, and/ or with EU and other international medical device regulations and submissions. . Familiar with relevant regulatory requirements for medical devices including Quality Systems standards, clinical… more
- Sanofi Group (Cambridge, MA)
- …well as other CNS diseases, with therapeutic modalities encompassing Small Molecules, Biologics , and Gene Therapy. We are an innovative global healthcare company ... with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought… more