Job Summary:
- Drug Metabolism and Pharmacokinetics (DMPK) plans and performs in vitro and in vivo metabolism/bioanalysis assays in support of DMPK studies in discovery and early development.
- The DMPK interprets data and communicates experimental results to his/her supervisor and colleagues.
- The incumbent works cross-functionally with internal departments, and external resources as appropriate, as part of organization's discovery science project teams.
- The DMPK supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
ESSENTIAL FUNCTIONS
Primary duties/responsibilities:
- With guidance, initiates and executes scientific research and experiments and interprets and communicates results as part of multi-disciplinary team(s).
- Performs and maintains established in vitro and in vivo metabolism/bioanalysis assays.
- With guidance, develops new, and improves upon existing DMPK assays.
- Performs hands-on in vitro and in vivo metabolism/bioanalysis assays using LC-MS/MS.
- Documents experiment details in lab books, records results in database and prepares study reports.
- Abides by all safety and regulatory guidelines.
- Performs other tasks and assignments as needed or specified by management.
- Contributes to general lab needs such as:
- Equipment maintenance and/or troubleshooting.
KNOWLEDGE/SKILLS/ABILITIES REQUIRED
* Minimum level of education and years of relevant work experience.**
- A Master's degree in Biology, Chemistry, Biochemistry, Pharmaceutical Science, Pharmacology or other related scientific discipline and a minimum of 2 years of relevant and progressively responsible experience in a pharmaceutical, biotechnology or similar environment OR a Bachelor's degree in these same disciplines and a minimum of 4 years of the same experience.
* Special knowledge or skills needed and/or licenses or certificates required.
- Demonstrated experience in conducting in vitro and in vivo DMPK studies, such as metabolic stability in liver microsomes and hepatocytes, CYP inhibition and induction, and bioanalysis in various matrices etc.
- Demonstrated experience in operating and troubleshooting contemporary LC-MS instruments and automated liquid handlers.
- Hands-on experience with liquid handlers, LC-MS instruments, and other equipment.
- Detailed knowledge of DMPK and applied techniques.
- Experience with developing and optimizing relevant DMPK assays.
- Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment that may consist of both internal and external team members.
- Proficiency with Microsoft Office.
- Good verbal and written communication skills.
- Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
- Excellent planning, organization, and time management skills including the ability to support and prioritize multiple projects
