- Alloy Therapeutics (Waltham, MA)
- …internal platforms. Cross-Functional Collaboration + Partner with discovery, analytical, and CMC teams to ensure seamless handoff of processes from bench research ... through clinical manufacturing. + Collaborate with regulatory, quality, and manufacturing functions to support IND and clinical-stage programs. + Build and manage external partnerships with CDMOs, suppliers, and academic collaborators to accelerate innovation… more
- Sanofi Group (Cambridge, MA)
- …and delivery of cutting-edge software solutions that transform Sanofi's laboratory and CMC manufacturing plant operations As a Lab Software Engineering Manager, you ... will lead a team of talented software engineers building solutions that power our global R&D laboratories. This team are on the ground, co-located with lab scientists and plant operators because they understand not only the scientific applications but also the… more
- CBRE (Boston, MA)
- …Housing loan requests, assessing key areas of risks and conformance with CMC , Fannie Mae and Freddie Mac credit standards and program requirements. Prepares ... underwriting submissions for loan committee. Strong work ethic and drive for excellence are essential to join this high-performance team. **What You'll Do:** + Responsible for credit and real estate analysis, processing incoming exhibits and preparing final… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …of regulatory submissions for OPDC R&D products. Performs quality reviews of CMC sections of regulatory submissions. + Authors and maintains Standard Operating ... Procedures, Working Practices and Job Aids. + Works collaboratively within the Global Quality and other functional areas across Otsuka Affiliates and Subsidiaries ensure Compliance with local and global requirements and regulatory requirements. + Interfaces… more
- Lilly (Boston, MA)
- …models and transformer architectures + Knowledge of antibody manufacturing and CMC considerations + Experience with display technologies (phage, yeast, mammalian) + ... Understanding of clinical immunogenicity and prediction methods + Proficiency in protein modeling tools (Rosetta, MOE, Schrodinger BioLuminate) + Familiarity with antibody-drug conjugates and bispecific platforms + Experience with federated learning in… more
- Takeda Pharmaceuticals (Lexington, MA)
- …understanding of regulatory guidance and industry standards relevant to analytical CMC activities, particularly in the development and validation of potency assays ... + Demonstrated ability to communicate complex data clearly and concisely, with excellent scientific writing skills, strong attention to detail, and a proven track record of effective cross-functional collaboration. **Takeda Compensation and Benefits Summary**… more
- Takeda Pharmaceuticals (Lexington, MA)
- …+ Contribute technical quality content to regulatory filings and collaborate with CMC submission teams. + Participate as SME in external audits, support PAI ... readiness, and contribute to supplier qualification and Quality Technical Agreements. + Build strong cross-functional relationships to enable agile pharmaceutical development and high-quality outcomes. **What you bring to Takeda** + Bachelor's degree in a… more
- Otsuka America Pharmaceutical Inc. (Waltham, MA)
- …& Analytics, Early Commercial, Medical Affairs, Nonclinical Toxicology, Clinical Pharmacology, CMC , and Global Pharmacovigilance. + Support and guide team through ... all Scientific Review Board and Endorsement Board interactions, as part of the EDO. **Cross-Functional and Governance Leadership** + Provide subject matter expertise and input to multidisciplinary teams across Discovery, Bioanalysis, Biomarkers, Toxicology,… more
- Bristol Myers Squibb (Cambridge, MA)
- …experience (20+years) of drug development or related experience managing clinical and CMC development under a variety of contexts; multiple clinical trials and ... operations required (ideally with pharma co and /or CRO) + A demonstrated track record of success leading, engaging, managing, and developing a large global multi-site, multi-cultural organization + Leadership experience of a large-scale enterprise… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, regulatory operations, etc.) to develop global regulatory ... plans, address global regulatory issues, health authority queries, and regulatory obligations. - Authors, coordinates, reviews, and executes submissions and responses to regulatory authorities related to INDs, amendments, supplements, aggregate reports, NDAs… more
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