- Takeda Pharmaceuticals (Boston, MA)
- …of pharmaceutical development and understand the global regulatory trends for CMC activities, to proactively shape strategies and ensure robust and high-quality ... of the global regulatory environment and evolving expectations relation to CMC , process development, and manufacturing of biologics. + Demonstrated ability to… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …site leadership, Technical Services, Pharmaceutical Sciences, Global Quality, and Regulatory CMC . + Provide technical support to marketing applications for global ... effectively within multi-disciplinary teams (Engineering, Manufacturing Operations, Manufacturing Sciences, CMC teams, and others). + Commitment to sharing knowledge… more
- Parexel (Boston, MA)
- …be a 40-hour-per-week position. **About Parexel** Parexel FSP includes the CMC Operations group. We provide pharmaceutical and biopharmaceutical companies with ... qualified and talented technical professionals to support the development and delivery of new therapies. For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet… more
- Eurofins US Network (Boston, MA)
- …scientists and engineers. The candidate will contribute to a variety of CMC activities in a fast-paced, agile, and highly collaborative environment. **Key ... Responsibilities:** + Routinely perform batch and stability testing of drug products using qualified methods. + Troubleshoot and resolve testing-related issues. + Maintain accurate records and documentation of test results. + Regularly perform analytical data… more
- Amgen (Cambridge, MA)
- …leader in delivering superior, robust drug product manufacturing processes, high-quality CMC sections, and ensuring supply of commercial products. Drug Product Team ... leaders (DPTLs) play a central role in this process by serving as single point of accountability for individual drug product programs for technical activities specific to formulation, aseptic drug product process design and validation, integrated development… more
- J&J Family of Companies (Cambridge, MA)
- …Analytical Reasoning, Biochemistry, Biotechnology, Chemistry, Manufacturing, and Control ( CMC ), Clinical Research and Regulations, Clinical Trial Designs, Coaching, ... Critical Thinking, Drug Discovery Development, Emerging Technologies, Molecular Diagnostics, Organizing, Pharmacovigilance, Presentation Design, Process Improvements, Productivity Planning, Scientific Research **The anticipated base pay range for this position… more
- Sanofi Group (Cambridge, MA)
- …and late stage, development of multiple modalities; experience within regulatory CMC not directly applicable. + Demonstrated experience with preparation of ... (s)BLA/(s)NDA/MAA, INDs/CTAs, HA meeting briefing documents and negotiating with a national/regional HA preferred. + Experience on multidisciplinary matrixed project teams (eg clinical study team) preferred. + Project leadership experience preferred. **Why… more
- Lilly (Boston, MA)
- …source documents to support phase-appropriate comparability. + Serve as the CMC representative on cross-functional project teams. + Provide technical oversight to ... guide analytical/QC investigations, as needed. + Actively collaborate with internal and external process development and quality teams. + Train and mentor junior team members _._ **Basic Requirements:** + MS degree in genetics, biochemistry, or molecular… more
- Parexel (Boston, MA)
- …update national systems in line with local legislation (renewals, PSURs, label updates, CMC changes). * Execute timely data entry and validation in Veeva Vault RIMS ... for submissions and approvals. Regulatory Submissions * Review, prepare, and submit dossiers; negotiate with HAs to secure approvals. * Provide local input for change control and post-approval requirements. * Collaborate with global functions to obtain… more
- Adecco US, Inc. (Framingham, MA)
- …a robust biologics pipeline and involves frequent cross-functional collaboration with global CMC partners across the US and Europe. **Key Responsibilities** + Design ... and construct expression vectors using advanced molecular cloning techniques (Gibson assembly, Golden Gate cloning, restriction enzyme cloning, site-directed mutagenesis) + Develop, optimize, and implement automated, high-throughput vector construction and DNA… more