This senior individual contributor role in Global Manufacturing Science (GMSci) is the subject matter expert and primary technical... substance (and relevant drug product) CMC sections for global submissions (e.g., IND/NDA/MAA and annual reports) and supporting...
, and cross-functional stakeholders in Regulatory Affairs. The Global Regulatory CMC Lead also supports Global Manufacturing... Job Description The Global Regulatory CMC Lead develops and executes global regulatory CMC strategy for assigned Sobi assets...
, Manufacturing, and Controls (CMC) Lead to join our team in Bend, OR. As the CMC Lead, Bioavailability Enhancement... and their families, if needed. Today, Lonza is a global leader in life sciences operating across five continents. While we work...
to lead global cross-functional teams to achieve regulatory success. Required Skills Bachelor’s degree in Life Sciences...About This Role As Associate Director, Regulatory CMC Small Molecule Lead, you will play a pivotal role in shaping...
Responsibilities: The Manager, MSAT – Cell Therapy will lead and execute Manufacturing Sciences & Technology (MSAT... manufacturing. This role is critical for enabling scale-up, ensuring cleanroom readiness, and operational execution in a contract...
Responsibilities: Tech Transfer Leadership Lead organization of TSMS technical experts on global tech transfer teams supporting... meetings. Build relationships and influence across manufacturing sites and central functions. Lead performance management...
Responsibilities: Lead the preparation, review, and submission of CMC sections of regulatory filings (e.g., INDs...). Strong understanding of global regulatory requirements, guidelines, and expectations related to CMC for pharmaceutical products (e.g...
, successful approvals, and long-term lifecycle management. Key Responsibilities Define and lead the global CMC regulatory strategy... leadership for global CMC regulatory activities across a growing pipeline of innovative therapeutics. This role is designed...
to Regulatory Chemistry, Manufacturing, and Controls (CMC) programs for pharmaceutical, biotechnology, and/or medical device clients... supporting global regulatory submissions Familiarity with FDA, EMA, ICH, and global CMC regulatory expectations PMP...
About the Job The CMC Dossier Sciences department within client R&D Global CMC Development organization has critical... AI-powered solutions and digital tools to transform how we prepare CMC regulatory documents Lead, coordinate, and manage CMC...
Associate Director/Director of CMC Regulatory Affairs to lead and execute regulatory activities for our ECO Synthesis platform... Synthesis platform and GMP siRNA manufacturing. Lead interactions with regulatory agencies, including ongoing discussions...
Job Description GRACS (Global Regulatory Affairs & Clinical Safety) CMC – Associate Principal Scientist, CMC – Pharm... responsibilities: Serve as a CMC Product Lead for assigned products and be accountable for the delivery of all regulatory milestones...
, working in collaboration with partners in Research, Process Sciences, Manufacturing, QC/QA, Global Supply Chain.... Your work will primarily encompass: Provide CMC regulatory expertise for global development and registration programs (e.g...
Development, Analytical Sciences, Manufacturing, Quality, Supply Chain, R&D, Finance, and Regulatory to ensure delivery of CMC... for the execution of multiple radiopharmaceutical CMC development and manufacturing programs supporting various therapeutic...
, working in collaboration with partners in Research, Process Sciences, Manufacturing, QC/QA, Global Supply Chain.... Your work will primarily encompass: Provide CMC regulatory expertise for global development and registration programs (e.g...
pharmaceutical sciences with modern data engineering to transform complex CMC, PAT, and analytical data into strategic assets...At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare...
and modest costs. Description of Role The Executive Director, Regulatory CMC will provide strategic leadership for global CMC... to accelerate development in a dynamic environment. Lead creation and execution of comprehensive CMC development plans for new...
and project teams and collaborate closely with Pharmaceutical Sciences, Global Manufacturing Sciences and Quality. Ensure...’s global Biologics Product Sciences team and become a member of the global team of product science experts responsible...
. Collaborate closely with Pharmaceutical Sciences, Global Clinical Supply Chain, and other partners to resolve quality events... Principal Manager, R&D GMP Pharmaceutical Sciences Quality EU & US provides Quality oversight across Takeda’s investigational...
structure-function correlation. Lead, mentor and develop high -performing analytical sciences teams Provide analytical input... and working with global teams and external CDMO's Knowledge of Quality by Design principles, cGMP, and CMC requirements...