Research Assistant supporting social science research initiatives at Vanderbilt University. Involves assisting with study procedures, data collection, and collaboration with research teams.
MS
Hybrid Associate Principal Scientist – Regulatory Affairs, CMC, Biologics
Posted last month
About the role
- Associate Principal Scientist implementing Chemistry, Manufacturing, and Controls regulatory strategies for biologics products. Preparing CMC sections for submissions and mentoring scientific staff.
Responsibilities
- Responsible for implementing Chemistry, Manufacturing, and Controls (CMC) regulatory strategies
- Preparation and submission of CMC sections for commercial or new biologics products
- Assist in the development and implementation of internal regulatory strategies
- Mentoring and coaching to Sr. Scientist / Scientist in support of their assigned projects
- Lead authoring of clear, concise and effective IND / CTAs, BLAs or global post approval submissions
- Collaborate with partner groups to ensure compliance, scientific excellence, accuracy and completeness of submissions
Requirements
- B.S. in a science, engineering, or a related field (advanced degree preferred)
- Prior Biologics IND, License Application (BLA) and/or post approval filing experience with at least 10 years subject matter expertise in biologics CMC development or manufacturing
- Experience in biologics regulatory CMC in both pre-approval and registration required, with experience authoring agency interactions, responses to questions, and IND/IMPD and BLA sections
- Demonstrated sound understanding of related fields (e.g., manufacturing, process development, analytical, quality assurance)
- Demonstrated superior oral and written communication skills in multicultural settings
- Demonstrated ability to generate innovative solutions to complex regulatory problems
Benefits
- medical, dental, vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays, vacation, and compassionate and sick days
Job title
Job type
Experience level
Salary
Degree requirement
Location requirements
Research Assistant part of Vanderbilt School of Nursing conducting studies following research guidelines. Requires strong communication and organizational skills to manage research activities.
Research Associate at HHL Leipzig Graduate School focusing on economic psychology and leadership. Engaging in research projects while supporting teaching and supervising students' theses.
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.