Sr. Principal Sci, Bioanalytical
Other Locations:US- CA- San Diego- Science Park
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
The Principal Scientist leads the development and implementation of assays to support nonclinical Absorption, Distribution, Metabolism and Excretion (ADME) studies. The ideal candidate possesses strong knowledge of drug metabolism and pharmacokinetics (DMPK) and advises early and late stage project teams in their area of expertise. To this end, he/she should be able to not only develop and drive DMPK strategies, design mechanistic studies and interpret results and solve ADME liabilities but also lead junior members to implement these strategies. Candidate should have a strong understanding of various DMPK disciplines including physicochemical properties, drug metabolizing enzyme & transporter kinetics, mechanistic biotransformation, bioanalytical data troubleshooting with the goal of presentation to regulatory agencies. An expectation of the candidate is they actively participate in and/or review regulatory submissions. This role has the added responsibility of being current in the latest regulatory agency guidances regarding ADME studies.
- Designs PK/PD models to support pharmacologic characterization of project compounds.
- Understand regulatory agency requirements for bioanalysis and ADME studies and support the regulatory submissions with this expertise.
- Lead the characterization and selection of project compounds through teaching and mentoring junior members to conduct and interpretation of ADME studies, including cytochrome P450 inhibition, protein binding, metabolic stability and solubility.
- A problem solver who creativity and knowledgably transcends departmental function to act as a resource to entire research effort and senior managers in development.
- Serve as an outsourcing liaison and technical expert for methods placed externally.
- Routinely evaluate regulatory environments within the US and globally to assess adequacy of departmental processes, documentation, and technologies to help ensure acceptance of data in regulatory submissions.
- Support cross-functional project teams for new product development.
- Create timely reports to update management on status of projects.
- Communicates within the larger organization and external community, regulatory interactions and CRO technical assessments.
- Partner with finance to manage to department budgets and time lines.
- Leads, develops and mentors staff.