Principal Scientist, DMPK

PTC Therapeutics, Inc. • Bridgewater, NJ

1d • Onsite

About The Position

PTC Therapeutics is a global commercial biopharmaceutical company. For over 25 years our team has been deeply committed to a unified purpose: Extending life’s moments for children and adults living with a rare disease. At PTC, we cultivate an inclusive culture where everyone feels valued, respected, and empowered. We welcome candidates from all backgrounds to join our team, fostering a strong sense of belonging. Visit our website to learn more about our company and culture! Site: www.ptcbio.com Job Description Summary: The Principle Scientist, DMPK is responsible for planning and performing in vitro and in vivo ADME studies that contribute to PTC’s research and development activities. The incumbent is also responsible for communicating experimental results to his/her supervisor and the project team. The incumbent works cross-functionally with internal departments, and external resources as appropriate, as part of PTC’s discovery science project teams. The Principle Scientist, DMPK supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate. . Job Description: ESSENTIAL FUNCTIONS Primary duties/responsibilities: Under limited direction plans, initiates and executes DMPK studies and interprets and communicates results as part of a multi-disciplinary team. Works with research and development teams in planning, scheduling and conducting DMPK studies per the development candidate nomination and IND/NDA timeline requirement. Serves as DMPK representative on project teams and interprets and presents data/results to cross-functional teams comprised of internal and external members. Performs hands-on in vitro and in vivo DMPK studies. These include, but may not be limited to, metabolic stability and metabolite profiling/identification, CYP inhibition and induction studies, pharmacokinetic studies and radiolabeled studies in lab animals and in humans. Documents experiment details in laboratory notebook and writes reports. Prepares relevant DMPK documents for development candidate nomination and IND/NDA purposes. Ensures the scientific quality of the experimental data. Provides direct oversight and/or leads interactions with the external Contract Research Organizations (CROs). Abides by all safety and regulatory guidelines. Contributes to general lab needs such as: Equipment maintenance Troubleshoot Performs other tasks and assignments as needed and specified by management.

Requirements

• PhD in Chemistry, Biology, Pharmaceutical science, Pharmacology or related scientific discipline and a minimum of 5 years of experience in drug metabolism OR a Master’s degree in these same disciplines and a minimum of 6+ years of experience in drug metabolism.
• Hands-on experience in conducting in vitro and in vivo DMPK studies.
• Demonstrated experience in drug metabolism and biotransformation, pharmacokinetics, pharmacodynamic and bioanalytical principles.
• Hands-on experience in using contemporary LC-MS/MS instruments.
• Demonstrated experience in developing protocols and writing study reports and other relevant documents for development candidate nomination and IND/NDA purposes.
• Ability to work on complex problems to produce experimental data across one or more projects.
• Ability to work effectively in a multi-disciplinary team environment.
• Proficiency with Microsoft Office.
• Excellent verbal and written communication skills.
• Ability to work independently and collaboratively in a fast-paced, matrixed, team environment consisting of internal and external team members.
• 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.

Nice To Haves

• PhD Knowledge and experience in conducting radiolabeled studies.
• Hands on experience in operating and general troubleshooting of contemporary LC-MS instruments and automated liquid handlers.
• Prior experience with INDs and/or NDAs.
• Hands on experience with cell-based (hepatocytes and transporters, etc.) assays.
• Proficient in using WinNonlin or other pharmacokinetic software.

Responsibilities

• Under limited direction plans, initiates and executes DMPK studies and interprets and communicates results as part of a multi-disciplinary team.
• Works with research and development teams in planning, scheduling and conducting DMPK studies per the development candidate nomination and IND/NDA timeline requirement.
• Serves as DMPK representative on project teams and interprets and presents data/results to cross-functional teams comprised of internal and external members.
• Performs hands-on in vitro and in vivo DMPK studies. These include, but may not be limited to, metabolic stability and metabolite profiling/identification, CYP inhibition and induction studies, pharmacokinetic studies and radiolabeled studies in lab animals and in humans.
• Documents experiment details in laboratory notebook and writes reports.
• Prepares relevant DMPK documents for development candidate nomination and IND/NDA purposes.
• Ensures the scientific quality of the experimental data.
• Provides direct oversight and/or leads interactions with the external Contract Research Organizations (CROs).
• Abides by all safety and regulatory guidelines.
• Contributes to general lab needs such as: Equipment maintenance Troubleshoot
• Performs other tasks and assignments as needed and specified by management.

Benefits

• In addition to base salary, PTC employees are also eligible for short- and long-term incentives.
• All eligible employees may also enroll in PTC’s medical, dental, vision, and retirement savings plans.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal
• Education Level: Ph.D. or professional degree
• Number of Employees: 251-500 employees