We have an exciting opportunity for an Analytical Method Development Scientist (Large Molecule Bio-analysis) to join our team in West Point, PA area.
Develops bio-analytical methods for bio-pharmaceutical compounds in using a of a variety of technology platforms in a manner consistent with current regulatory and GxP expectations for bio-analysis. The analytical method development scientist supports commercial readiness activities, generates results, solves problems, communicates with both internal and external stakeholders.
- Development of analytical methods for assay validation assays using a variety of analytical techniques..
- Conducts method qualification and validation
- Accepts leadership role in troubleshooting and solving challenging bio-analytical problems
- Applies and interprets scientific theories, concepts, techniques, and regulatory requirements in bio-analytical and ligated binding studies and helps to develop scientific approaches.
- Independently sets up, maintains, operates and performs routine and non-routine maintenance on general equipment, including problem identification and resolution.
- Promotes a cohesive team environment.
- Monitors, evaluates, and reviews the scientific performance of assays.
- Assists with the transfer and support of methods to CRO/CMOs
- Effectively interacts with internal/external clients, as needed.
- Performs other related duties as assigned.
BS/BA degree in science plus at least 5-7 years of previous laboratory experience.
Effective communication (verbal and written), presentation and interpersonal skills.
- Skilled in working in the late stage/commercial space
- Authority on a variety of analytical methods.
- Familiar with the use of standard laboratory equipment.
- Experience and knowledge of analytical instrumentation (e.g., plate readers, HPLC, )
- Knowledge of laboratory automation software, system software, and Microsoft applications.
- Effective oral and written communication skills.