Our Client is looking for a remote Senior Consultant, Biotech Analytical Services to work out of their home office with 50% travel. This is a direct hire, permanent position.
- 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
Competencies (soft skills, traits, behaviors):
- Shows initiative
- Results oriented
- Creative thinker
- Detail oriented
- Focused on continuous development
- Thorough understanding of analytical technology, method development, method qualification/validation, and global regulatory analytical requirements
- Laboratory experience performing method development, qualification, and validation activities
- Required - experience in Biotech (large molecule) and writing sections of BLA
- Analytical Drug Development Experience for a pharmaceutical company or FDA
- Experience with bioassay and 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 (50%)
- PhD in Analytical Chemistry, Biochemistry, or related discipline, with 4+ years relevant experience