Research Associate at HHL Leipzig Graduate School focusing on economic psychology and leadership. Engaging in research projects while supporting teaching and supervising students' theses.
About the role
- Principal Scientist/Director responsible for regulatory strategies for biologics products. Overseeing CMC regulatory submissions and leading cross-functional teams in compliance and submission accuracy.
Responsibilities
- Responsible for developing and implementing Chemistry, Manufacturing, and Controls (CMC) regulatory strategies
- Leading the preparation and submission of CMC sections for commercial or new biologics products
- Provide CMC Regulatory leadership within Regulatory and on cross-functional teams
- Develop and execute detailed global regulatory submissions
- Collaborate with partner groups to ensure compliance, scientific excellence, accuracy, and completeness of submissions
- Resolve complex project issues through collaboration and provide recommendations to Regulatory CMC leadership team as appropriate.
Requirements
- B.S. in a biological science, engineering, or a related field (advanced degree preferred)
- At least ten years of relevant experience including biologics or vaccine Regulatory CMC, or development; manufacturing, testing, or licensure of biological products; or closely related fields.
- Strong listening skills.
- The candidate must be proficient in English; additional language skills are a plus.
- The candidate may be required to travel on a periodic basis.
Benefits
- medical, dental, vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days
Job title
Job type
Experience level
Salary
Degree requirement
Location requirements
Senior Research Scientist focusing on quantum algorithms, driving near - term quantum advantage. Working on cutting - edge applications in a multidisciplinary environment.
Staff/Senior Research Scientist driving development of AI frontier benchmarks and datasets at Snorkel AI. Collaborating across teams to scale production and impact research community.
Research Scientist focusing on reinforcement learning for training large language models at Snorkel AI. Collaborating with research and engineering teams to advance RL data capabilities.
Research Scientist conducting original research in AI and machine learning for Spotify's Personalization team. Developing methodologies and collaborating with partners to advance personalization systems.
Research Scientist at Valence Labs developing ML models for predicting cellular responses in drug discovery. Building generative models based on massive multiomics datasets with collaborative research.
Research Assistant responsible for statistical data analysis under a Principal Investigator for health science projects. Involves data management, statistical analyses, and documentation of workflows.
Temporary Research Assistant supporting data collection for Medical Ethics at University of Pennsylvania. Engaging in programming activities and organizing research - related documentation.
Machine Learning Research Scientist conducting applied AI/ML research at SEI. Developing prototype capabilities for government workflows with a focus on mission context.
Summer Research Assistant helping with research and field work in agroforestry systems. Collecting data and assisting in various tasks based in Wisconsin.