LabTemps is looking for a remote Senior Consultant of Analytical Services to work with our client out of their home office with 50% travel.
- 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 method transfer, qualification, and validation protocols, analytical technical reports, and CMC regulatory documentation.
- Writes regulatory documentation.
- 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 strategy, impurity identification, Quality-by-Design, 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 our clients marketing efforts by actively seeking new clients and repeat business opportunities.
- Keeps current with technical developments in the industry and regulatory agency thinking.
- Types of Projects: Recombinant proteins, peptides, oligonucleotides, Gene and Cell Therapies