Contract, DMPK Operations

PTC Therapeutics, Inc. • Bridgewater, NJ

1d • $35 - $50 • Onsite

About The Position

The Contract, DMPK Operations contributes to PTC’s drug discovery and development efforts by monitoring DMPK study operation, managing study data and overseeing DMPK lab operations. This includes, but may not be limited to, managing and maintaining the DMPK assay submission sheets, tracking the progress of the planned studies conducted externally and internally, ensuring study documents are assembled to the appropriate repository databases in a timely manner. The incumbent works cross-functionally with internal departments and external resources on DMPK operations-related issues. The incumbent, DMPK Operations, supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Requirements

• Bachelor or Master’s degree in Pharmaceutical Sciences, Pharmacology or related scientific discipline and a minimum of 2 years of experience in DMPK and/or pharmaceutical regulatory documentation or equivalent experience.
• Demonstrated ability to manage timelines and quality of work using strong organizational, communication, facilitation, and interpersonal skills in a cross-functional team.
• Ability to work independently and collaboratively in a fast-paced, matrix-based team environment consisting of internal and external team members.
• Ability to work effectively in a multi-disciplinary team environment.
• Sense of urgency, flexibility, and ability to prioritize or shift priorities to meet aggressive and changing timelines.
• General knowledge in the principles of DMPK operations.
• Proficiency with Microsoft Office.
• Excellent verbal and written communication skills.

Nice To Haves

• Working knowledge in DMPK and Bioanalysis.

Responsibilities

• Maintains the DMPK assay submission sheets for both internal and outsourced DMPK studies.
• Collaborates with DMPK colleagues in execution of the planned studies.
• Tracks the progress of the planned studies and ensures the studies are completed timely.
• Manages the final study documents in the appropriate DMPK data folders.
• Uploads the final study data into databases in a timely manner.
• Independently performs routine lab operations activities. This includes, but may not be limited to, tracking study samples shipments and arrivals; ordering and maintaining lab supplies and other inventory; shipping samples to internal/external research facilities; coordinating the centralized lab safety and lab equipment maintenance; and achieving study records at an archival facility.
• Performs other tasks and assignments as needed and specified by management.
• Abides by all safety and regulatory guidelines.

What This Job Offers

• Career Level: Entry Level
• Number of Employees: 251-500 employees