- Sanofi Group (Cambridge, MA)
- …functions, including GDPU and GDPQ, QA/RA, M&S Site and global functions, MSAT, CMC teams and external partners, assigned to the program. + With your team ... of the pharmaceutical product, and process engineering, project/program management, quality, regulatory and supply. + This role requires a strategic thinker with… more
- Sanofi Group (Cambridge, MA)
- …toward all GPT members, including eg project management, clinical operations, regulatory , safety, translational medicine, statistics, CMC , IA **Basic ... The GPH will be delegated such responsibilities as interaction with regulatory /health authorities (HA), approval of documents and product label, as appropriate.… more
- Honeywell (Baton Rouge, LA)
- …and maintenance of cGMP documentation for compliance with quality and regulatory standards. The GMP QA Manager also monitors Contract Manufacturing Organizations ... internal SOPs, company policies and procedures, safety and environmental and regulatory requirements + Reviews cGMP batch manufacturing and packaging records and… more
- Lundbeck (Bothell, WA)
- …Process Development Center of Excellence for Biologics within the global Lundbeck CMC organization. Since integrating into Lundbeck in October 2019, Lu-SBP has ... capacity, manage outsourced cell line development activities, author relevant regulatory sections, collaboratively support cell culture development to optimize… more
- Bristol Myers Squibb (Summit, NJ)
- …clinical manufacturing. Additional duties involve supporting IND/IMPD and other regulatory filings, authoring technical reports, and contributing to ongoing platform ... troubleshooting efforts when needed. + Participating as a DS representative in cross-functional CMC teams including external CMO to help advance the program in a… more
- ThermoFisher Scientific (San Diego, CA)
- …for storage and testing. Conducts work in compliance with safety and regulatory requirements. May provides supervisory role for junior employees. + Responsible for ... to lead multiple stability programs with moderate to high complexity within CMC . + Coordinates communication with internal customers and external vendors. +… more
- AbbVie (North Chicago, IL)
- …role ensures governance is standardized, trusted, and embedded into Ops AI initiatives (Digital CMC , NEO, OMEGA and ALPHA), Factory of the Future, Lab/ QA of the ... in alignment with AbbVie's enterprise data governance framework and regulatory (GxP/GMP) requirements. + Provide portfolio-level oversight of governance activities,… more
- AbbVie (Worcester, MA)
- …will also coordinate and lead purification development activities within cross-functional CMC teams with a collaborative and progressive mindset. This position is ... development team and actively influence development strategy on cross-functional CMC teams + Work efficiently, collaboratively, and cross-functionally toward project… more
- Sanofi Group (Framingham, MA)
- …support MSAT programs and global manufacturing sites, and to collaborate with R&D/ CMC teams. + Lead complex manufacturing investigation such as large column packing ... manufacturing staff at pilot facility. Work with MSAT and CMC pilot teams to drive the necessary pilot data...Internal and external manufacturing sites + Support Quality and Regulatory during health authority inspection and prepare for supportive… more
- AbbVie (Waltham, MA)
- …Science and Technology (PDS&T) Analytical Development - Waltham is responsible for CMC analytical development activities for antibody drug conjugates (ADCs). We are ... method development, optimization, validation, advanced characterization, process development support, regulatory authoring, and control strategy for ADCs. The team… more