Wissenschaftlicher Mitarbeiter responsible for microbiology projects at MVZ diagnosticum GmbH. Leading teams and organizing workflows within medical laboratory environment in Neukirchen.
MS
Hybrid Associate Principal Scientist – Regulatory Affairs, CMC, Biologics
Posted 3 hours ago
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
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