Senior Scientist
CHEManager International · Exton, PA · 3 days ago
AnalystFull-time
Frontage Laboratories Inc. (Frontage) is a global contract research organization with broad expertise in supporting pre-clinical and clinical drug development. Our biologics scientists have developed and validated a large number of large molecule ADA/NAB assays for pharmaceutical and biotech companies, establishing us as a benchmark in the field.
About the role
Senior Scientist responsible for the development of bioanalytical methods and lead sample analysis in our Biologics Services team.
Responsibilities
- Conduct method development and validation for bioanalytical methods and conduct sample testing for various analytical targets.
- Provide updates and reports, resolve any unexpected issues, and ensure agreed upon timelines.
- Prepare and/or review study protocols, test reports, SOPs, deviations, and change control actions.
- Communicate with clients directly.
- Comply with all relevant GLP and FDA regulatory requirements while carrying out assigned tasks.
- Utilize various types of instruments including MSD, ELISA, and automation equipment.
Requirements
- Ph.D. or Master's degree in Analytical Chemistry, Biochemistry, Biology, or related scientific discipline with 3+ years of direct experience in bioanalytical method development for large molecules in ADA/NAB assays.
- Experience with ADA/NAB assays method development, validation, and sample analysis is a plus.
- Proven ability to successfully work in a team environment.
- Excellent oral and written communication skills.
- Good knowledge and application of GLP with the ability to train technical personnel.
- Efficient time management.
- Strong troubleshooting and analytical skills.
- Detail-oriented and meticulous.
- Ability to work independently under time constraints.
Benefits
- Competitive compensation and benefits package.
- Health and dental insurance.
- 401(k) plan.
- Disability insurance.
- Life insurance.