- 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 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 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 BioTechLogic’s 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, Gene and Cell Therapies
Competencies (“soft skills", traits, behaviors):
- Shows initiative
- Results oriented
- Creative thinker
- Detail oriented
- Focused on continuous development
- 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)
- PhD in Analytical Chemistry, Biochemistry, or related discipline, with 4+ years relevant experience
Job Type: Full-time
Pay: $120,000.00 - $180,000.00 per year
- 401(k) matching
- Dental insurance
- Disability insurance
- Health insurance
- Paid time off
- Monday to Friday
- Bonus pay
- Master's (Required)
- Laboratory Experience: 4 years (Required)
Willingness to travel:
- 50% (Preferred)
- Fully Remote
- Remote interview process
- Virtual meetings
Work Location: Remote