Principal Scientist, DMPK
PTC Therapeutics, Inc.
5 months ago
On-site
Bridgewater, NJ
Clinical Research and Development
Principle Scientist, DMPK
Job Description Summary
- Responsible for planning and performing in vitro and in vivo ADME (drug metabolism) studies that contribute to R&D.
- Communicates experimental results to supervisor and the project team.
- Works cross-functionally with internal departments and external resources as appropriate.
- Supports adherence to relevant regulatory requirements and company SOPs.
Essential Functions / Primary Duties
- Under limited direction, initiates and executes DMPK studies; interprets and communicates results as part of a multi-disciplinary team.
- Plans, schedules, and conducts DMPK studies per development candidate nomination and IND/NDA timeline requirements.
- Serves as DMPK representative on project teams; interprets and presents data/results to cross-functional internal/external teams.
- Performs hands-on in vitro and in vivo DMPK studies including metabolic stability/metabolite profiling, CYP inhibition/induction, pharmacokinetic and radiolabeled studies in lab animals and humans.
- Documents experiments (laboratory notebooks), writes reports, and prepares DMPK documents for development candidate nomination and IND/NDA purposes.
- Ensures scientific quality of experimental data.
- Provides direct oversight and/or leads interactions with external CROs.
- Abides by safety and regulatory guidelines.
- Contributes to general lab needs (equipment maintenance, troubleshoot).
Qualifications (Minimum)
- PhD in Chemistry, Biology, Pharmaceutical Science, Pharmacology, or related discipline with 5+ years drug metabolism experience; or Master’s degree with 6+ years drug metabolism experience.
Knowledge/Skills/Abilities Required
- Hands-on in vitro and in vivo DMPK experience.
- Experience in drug metabolism/biotransformation, pharmacokinetics, pharmacodynamics, and bioanalytical principles.
- Hands-on use of contemporary LC-MS/MS; experience troubleshooting and automated liquid handlers.
- Experience developing protocols and writing study reports/documents for IND/NDA.
- Ability to handle complex problems and generate data across projects.
- Works effectively in multi-disciplinary, fast-paced matrix environments; strong planning/time management.
- Proficiency with Microsoft Office; excellent written and verbal communication.
Preferred
- Knowledge/experience conducting radiolabeled studies.
- Prior experience with INDs and/or NDAs.
- Hands-on experience with cell-based assays (e.g., hepatocytes and transporters).
- Proficient in WinNonlin or other pharmacokinetic software.
- Special knowledge/skills/licenses/certificates.
Compensation / Benefits (explicitly stated)
- Expected base salary range: $153,500–$185,000.
- Eligible for short- and long-term incentives; medical, dental, vision, and retirement savings plans.
Travel
- 0–10%.
Work Setting
- Laboratory-based position.
Job Description Summary
- Responsible for planning and performing in vitro and in vivo ADME (drug metabolism) studies that contribute to R&D.
- Communicates experimental results to supervisor and the project team.
- Works cross-functionally with internal departments and external resources as appropriate.
- Supports adherence to relevant regulatory requirements and company SOPs.
Essential Functions / Primary Duties
- Under limited direction, initiates and executes DMPK studies; interprets and communicates results as part of a multi-disciplinary team.
- Plans, schedules, and conducts DMPK studies per development candidate nomination and IND/NDA timeline requirements.
- Serves as DMPK representative on project teams; interprets and presents data/results to cross-functional internal/external teams.
- Performs hands-on in vitro and in vivo DMPK studies including metabolic stability/metabolite profiling, CYP inhibition/induction, pharmacokinetic and radiolabeled studies in lab animals and humans.
- Documents experiments (laboratory notebooks), writes reports, and prepares DMPK documents for development candidate nomination and IND/NDA purposes.
- Ensures scientific quality of experimental data.
- Provides direct oversight and/or leads interactions with external CROs.
- Abides by safety and regulatory guidelines.
- Contributes to general lab needs (equipment maintenance, troubleshoot).
Qualifications (Minimum)
- PhD in Chemistry, Biology, Pharmaceutical Science, Pharmacology, or related discipline with 5+ years drug metabolism experience; or Master’s degree with 6+ years drug metabolism experience.
Knowledge/Skills/Abilities Required
- Hands-on in vitro and in vivo DMPK experience.
- Experience in drug metabolism/biotransformation, pharmacokinetics, pharmacodynamics, and bioanalytical principles.
- Hands-on use of contemporary LC-MS/MS; experience troubleshooting and automated liquid handlers.
- Experience developing protocols and writing study reports/documents for IND/NDA.
- Ability to handle complex problems and generate data across projects.
- Works effectively in multi-disciplinary, fast-paced matrix environments; strong planning/time management.
- Proficiency with Microsoft Office; excellent written and verbal communication.
Preferred
- Knowledge/experience conducting radiolabeled studies.
- Prior experience with INDs and/or NDAs.
- Hands-on experience with cell-based assays (e.g., hepatocytes and transporters).
- Proficient in WinNonlin or other pharmacokinetic software.
- Special knowledge/skills/licenses/certificates.
Compensation / Benefits (explicitly stated)
- Expected base salary range: $153,500–$185,000.
- Eligible for short- and long-term incentives; medical, dental, vision, and retirement savings plans.
Travel
- 0–10%.
Work Setting
- Laboratory-based position.