Senior Molecular Development Specialist

6 days ago


Tampa, Florida, United States Planet Pharma Full time
Key Responsibilities
">* Lead and provide scientific oversight of analytical strategy and studies for the evaluation of safety attributes of cell therapy and protein drug products, drug substances, and process intermediates.
">* Develop and execute method development, qualification, validation or verification, troubleshooting, and sample analysis by QbD approach and harmonized to USP monographs.
">* Provide technical leadership and scheduling for the team to ensure deliverables, coordination of external testing required, and data collection.
">* Author protocols and associated reports per Good Documentation Practices (GDP). Compile data packages, reports, and author/review sections for regulatory filings.
">* Serve as department subject matter expert supporting all aspects of external planning and execution of outsourced activities by CROs.
">* Maintain a high level of professional expertise through regular consulting of scientific literature and attendance of training and/or scientific seminars.

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