- Sanofi Group (Cambridge, MA)
- …products within the Sanofi portfolio of products. The team is part of the GRA CMC & GRA Device Department within Global R&D. The GRA Device organization serves as a ... critical strategic partner within Sanofi's regulatory framework, providing expert guidance on medical device regulatory requirements across the product lifecycle. Our department bridges the gap between technical development, manufacturing operations, and… more
- Sanofi Group (Cambridge, MA)
- …products within the Sanofi portfolio of products. The team is part of the GRA CMC & GRA Device Department within Global R&D. The GRA Device organization serves as a ... critical strategic partner within Sanofi's regulatory framework, providing expert guidance on medical device regulatory requirements across the product lifecycle. Our department bridges the gap between technical development, manufacturing operations, and… more
- Takeda Pharmaceuticals (Boston, MA)
- …regulatory interactions, including the preparation of Chemistry, Manufacturing, and Controls ( CMC ) content for dossiers. Additionally, you will ensure that process ... knowledge is effectively shared and utilized across various sites, serving as Takeda's global DP SME for resolving issues. **How will you contribute:** + Lead the following activities, along with Pharmaceutical Sciences and/or Operation Units: + Technology… more
- ThermoFisher Scientific (Plainville, MA)
- …we serve. We This position is part of Chemistry, Manufacturing and Controls ( CMC ) Development team and part of Manufacturing Science and Technology (MSAT). **Job ... Title: Manager - MSAT Downstream Lead** **Location:** US - Massachusetts - Plainville | 100% onsite **Division Specific Information** : Pharma Services | Viral Vectors **How will you make an impact?** Manager MSAT Downstream will: + Serve ad subject matter… more
- Lilly (Boston, MA)
- …as needed. + Ensure prompt evaluation by functional experts (Biology, Chemistry, CMC , ADME, TOX, PK, legal etc.) for opportunity evaluation and pre-diligence and ... provide partners with essential feedback/guidance. + Identify gaps and key issues and appropriate expertise to enable resolution. + Collaborate with internal scientific teams to identify, design, and implement the scientific experiments necessary to validate… more
- Parexel (Boston, MA)
- …regulatory requirements. * Act as key partner to GRA Regions, Regulatory CMC and Supply Chain. Qualifications: * University degree in Life Sciences, Chemistry, ... Engineering, or related pharmaceutical field; advanced degree (MSc, PhD, PharmD) preferred. * Minimum 5 years of biotech/pharma industry experience, including 2+ years in labeling/regulatory operations with global responsibility. * Experience leading teams in… more
- Sanofi Group (Waltham, MA)
- …an integrated end-to-end mRNA vaccine capabilities and research platform with R&D, digital and CMC teams. Bring your ambition and optimism and join us on our journey ... to discover and deliver transformative medicine to patients through the advancement of our cutting-edge mRNA technology! As an mRNA co-op student in Analytical Sciences, you will ensure laboratory activities in support of process development and… more
- Takeda Pharmaceuticals (Boston, MA)
- …of new innovative medicines for our patients around the world through robust CMC processes. Global Manufacturing Science is a part of Global Manufacturing and Supply ... and is based in Boston. **How you will contribute:** + Support the commercial manufacturing of active pharmaceutical ingredients/drug substances through the review of relevant documents and compile certain parameters in excel sheet + Perform statistical tools… more
- AbbVie (Worcester, MA)
- …the pharmaceutical industry. This is a reality for AbbVie Interns. The Biologics CMC Developability (BCD) group sits at the interface of discovery and development. ... The core role of BCD is to deliver meaningful and actionable data to support stakeholders in the selection of candidate molecules to progress through the pipeline. The group applies innovative high throughput assays by leveraging automation to enable support… more
- Sanofi Group (Waltham, MA)
- …end-to-end data integration and advanced analytics (pre-clinical, biomarkers, process development, CMC , clinical) in the mRNA CoE. Deploying and exploiting digital ... solutions (AI/machine learning, data, analytics) to integrate the full data value chain, extracting actionable information for a move to a full data driven strategy and decision-making process, to increase probability of success and to accelerate mRNA vaccines… more