Planet Pharma | Senior Scientist | tampa, fl
1 day ago
Senior Scientist needed (Analytical Development, Molecular)
Location: Tampa, FL
Salary: market rate
Essential Functions and 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, including assay format selection based on risk-assessment and fit-for-purpose.
- Lead and execute method development, qualification, validation or verification, troubleshooting and sample analysis by QbD approach and harmonized to USP monographs. Ensure assays are developed and executed per applicable Guidance and Regulations. Contribute to assay protocol and qualification/validation report preparation. Address quality assurance (QA) findings and observations.
- Subject matter expertise in developing and performing analytical methods and data analysis of release assays. Independently employ analytical strategy for the assessment of the genetic modification of human T cells and receptors.
- Subject matter expertise in developing and performing analytical methods and data analysis of assays including for genome integrity, genotyping for allelic KO, WGS, NGS, viral copy, protein expression, gene expression, immunophenotyping, ligand-binding, cytotoxicity.
- Lead, train and mentor small technically focused group of associates and junior scientists.
- 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.
- Lead, train and mentor small technically focused group of associates and junior scientists. Provide technical leadership and scheduling for the team to ensure deliverables, coordination of external testing required, and data collection.
- Serve as department subject matter expert supporting all aspects of external planning and execution of outsourced activities by CROs. Provide project management oversight of, and demonstrate ability to troubleshoot, external contracts for analytical method and critical reagent testing.
- Provide project updates on execution to timelines and resource allocation requests. Demonstrate professional-level presentation and communication skills in providing summaries of complex analysis of data sets to Senior and Executive level staff.
- Maintain a high level of professional expertise through regular consulting of scientific literature and attendance of training and/or scientific seminars. Investigate and develop new methods and technologies necessary for project advancement. Help identify patentable inventions. Contribute to scientific presentations and publications.
- Ensure training is up to date on new processes and analytical methods. Ensure compliance and maintenance of lab safety, environment, and quality. Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
- Adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
Travel –
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