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Senior Scientist

4 months ago

Germantown, United States Meet Full time

Senior Scientist, Analytical Development

Onsite 5x per week.


Job Description:

A leading biotechnology company specializing in vaccine development is seeking a Senior Scientist to join its Analytical Development department. This role will involve leading a team of scientists and overseeing the development, qualification, and validation of molecular separation assays for vaccine products. The ideal candidate will have a strong background in HPLC, LC/MS, and Size Separation methods, and will work collaboratively with cross-functional teams.


Key Responsibilities:

  • Lead and build a team of professionals in developing, qualifying, and validating separation methods for characterizing recombinant protein vaccine products.
  • Provide scientific guidance to cross-functional teams.
  • Apply cutting-edge technologies to improve throughput for in-process testing and enhance product characterization capabilities.
  • Perform method transfers to QC, other groups, and external partners.
  • Analyze results and methods, troubleshoot assays, and ensure regulatory compliance.
  • Prepare and review standard operating procedures, method development reports, qualification/validation protocols and reports, and scientific publications.
  • Write, edit, and review analytical sections of CMC regulatory filings.
  • Maintain effective communication with process development, formulation development, QC, QA, research, and clinical immunology teams.
  • Present scientific findings at internal and external meetings.
  • Assign work and provide guidance to team members to achieve goals.

Required Knowledge, Skills, and Abilities:

  • Informal management/team lead experience.
  • Strong expertise in developing separation methods for recombinant proteins.
  • Proven assay development skills.
  • Ability to manage and motivate a team of scientists.
  • Demonstrated leadership skills and capability to work collaboratively and cross-functionally.
  • Strong data analysis skills using statistical tools and ability to compile and review technical reports.
  • Knowledge of current Good Manufacturing Practices (GMPs) is preferred.
  • Excellent record-keeping abilities for regulatory compliance.
  • Strong communication, presentation, and writing skills.

Education and Experience:

  • PhD in analytical science, chemistry, biochemistry, or a related field.
  • Minimum of 8 years of experience in biopharmaceutical and/or vaccine development.