Senior Consultant, Analytical Services

Company

Barrington James

Job type

Full time

Essential functions:

  • Manages multiple analytical projects related to the development, qualification and/or troubleshooting of sensitive, efficient, and reliable assays for a wide class of biological molecules simultaneously.
  • Prepares, reviews, and edits analytical method development, transfer, qualification, and validation protocols and reports.
  • Writes CMC regulatory documentation for analytical methods.
  • Provides technical expertise and advises project representatives/teams on topics pertaining to biopharmaceutical analysis and CMC development, including: assay development and selection, structure-activity relationships, product characterization and comparability strategies, impurity identification, Quality-by-Design, Process Analytical Technology, product quality attribute classification, and study design. Often presents findings and/or results to client senior management.
  • Communicates effectively in a timely manner with external and internal clients regarding technical, scientific and other project related issues and progress.
  • Provides technical guidance to others in resolving challenging issues relating to analytical methods
  • Supports marketing efforts by participating in new client pitches and actively seeking repeat business opportunities
  • Keeps current with technical developments in the industry and regulatory agency thinking.
  • Types of Projects: Recombinant proteins, peptides, oligonucleotides, cell and gene therapies


Job Requirements:

Competencies (“soft skills", traits, behaviors):

  • Self-motivated
  • Shows initiative
  • Results oriented
  • Creative thinker
  • Detail oriented
  • Focused on continuous development


Knowledge/Skills/Abilities:

  • Thorough understanding of a wide spectrum of analytical technologies, method development, method qualification/validation, and global regulatory analytical requirements
  • Laboratory experience performing method development, transfer, qualification, and validation activities
  • Experience with multiple compendial methods such as pH, endotoxin, and UV assays
  • Experience with chromatographic assays
  • Experience with bioassay and/or potency assays a plus
  • Regulatory experience preferred
  • Proven ability to successfully work in a team environment
  • Excellent oral and written communication skills
  • Ability to make independent decisions
  • Willingness to travel (up to 50% once deemed safe to travel again)


Education/Experience:

  • PhD in Analytical Chemistry, Biochemistry, or related discipline, with 4+ years relevant experience

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