Principal Scientist, DMPK

EPM Scientific; Bridgewater (MA); On-site; USD 150,000 - 210,000; Full time

Job summary

EPM Scientific is seeking a Principal Scientist, DMPK in Bridgewater, MA to lead planning and execution of in vitro and in vivo ADME studies that support discovery and development programs. The role requires cross-functional collaboration, data interpretation, and communication with leadership and project teams to ensure regulatory and SOP compliance.

The candidate will oversee DMPK experiments (metabolic stability, profiling, CYP studies, PK, radiolabeled work) and manage CRO interactions,

Qualifications

• PhD with 5+ years of drug metabolism experience or a Master’s with 6+ years of experience.
• Hands-on experience conducting in vitro and in vivo DMPK studies.
• Experience designing study protocols and reporting for IND/NDA submissions.

Responsibilities

• Plans, initiates, and executes DMPK studies and communicates results to a multidisciplinary team.
• Collaborates with R&D to align studies with nomination and IND/NDA timelines.
• Represents DMPK on project teams and presents data to internal/external stakeholders.
• Performs in vitro and in vivo DMPK work: metabolic stability, metabolite profiling, CYP studies, PK, radiolabeled studies.
• Documents methods and results for candidate nomination and regulatory submissions.
• Leads interactions with CROs and ensures safety and regulatory compliance.
• Supports lab operations: equipment maintenance and troubleshooting.

Skills

DMPK studies

LC-MS/MS

Study protocols

Cross-functional collaboration

Communication

Education

PhD in Chemistry/Biology/Pharmaceutical Sciences/Pharmacology

Master's in related discipline

Tools

LC-MS/MS instrumentation

WinNonlin or PK software

Job description

The Principal Scientist, DMPK is responsible for planning and performing in vitro and in vivo ADME studies that support research and development activities. The role also includes communicating experimental results to leadership and project teams.

This position works cross-functionally with internal departments and external partners as part of discovery science project teams, while supporting adherence to regulatory requirements and internal Standard Operating Procedures (SOPs).

About the Company

This is a global commercial biopharmaceutical organization. For over 25 years, the team has been deeply committed to a unified purpose: extending life's moments for children and adults living with rare diseases.

The organization fosters an inclusive culture where everyone feels valued, respected, and empowered. Candidates from all backgrounds are encouraged to apply, supporting a strong sense of belonging.

Visit the company website to learn more about its mission and culture.

Primary Responsibilities

• Under limited direction, plans, initiates, and executes DMPK studies; interprets and communicates results within a multidisciplinary team.
• Collaborates with research and development teams to plan, schedule, and conduct DMPK studies aligned with candidate nomination and IND/NDA timelines.
• Serves as the DMPK representative on project teams; presents and interprets data for cross-functional stakeholders (internal and external).
• Perform hands‑on in vitro and in vivo DMPK studies, including but not limited to:
• Metabolic stability
• Metabolite profiling/identification
• CYP inhibition and induction studies
• Pharmacokinetic studies
• Radiolabeled studies in animals and humans
• Documents experimental details and prepares reports; contributes to DMPK documentation for candidate nomination and IND/NDA submissions.
• Ensures scientific quality and integrity of experimental data.
• Oversees and/or leads interactions with external Contract Research Organizations (CROs).
• Complies with all safety and regulatory guidelines.
• Supports general laboratory operations, including:
• Equipment maintenance
• Troubleshooting
• Performs additional tasks as assigned by management.

Education & Experience

• PhD in Chemistry, Biology, Pharmaceutical Sciences, Pharmacology, or a related discipline with 5+ years of drug metabolism experience

OR

• Master's degree in a related discipline with 6+ years of drug metabolism experience

Required Knowledge, Skills & Abilities

• Hands-on experience conducting in vitro and in vivo DMPK studies.
• Strong background in drug metabolism, biotransformation, pharmacokinetics, pharmacodynamics, and bioanalytical principles.
• Experience operating LC-MS/MS instrumentation.
• Proven ability to develop study protocols and author reports supporting candidate nomination and IND/NDA submissions.
• Ability to solve complex scientific problems and generate high-quality data across multiple projects.
• Strong collaboration skills in a multidisciplinary team environment.
• Proficiency with Microsoft Office.
• Excellent written and verbal communication skills.
• Ability to balance independent work with collaboration in a fast-paced, matrixed environment.
• Strong analytical, problem-solving, planning, and organizational skills with the ability to manage multiple priorities.

Preferred Qualifications

• PhD (if not already required by experience pathway)
• Experience with radiolabeled studies
• Hands‑on experience troubleshooting LC-MS systems and automated liquid handlers
• Prior experience supporting IND and/or NDA submissions
• Experience with cell-based assays (e.g., hepatocytes, transporter systems)
• Proficiency in WinNonlin or similar pharmacokinetic software