Contract, DMPK Operations

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 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.
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Job Description:

ESSENTIAL FUNCTIONS

Primary duties/responsibilities:

Under the mentorship of supervisor:

• 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.

KNOWLEDGE/SKILLS/ABILITIES REQUIRED

* Minimum level of education and years of relevant work experience.

• 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.

* Special knowledge or skills needed and/or licenses or certificates required.

• 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.

*Special knowledge or skills and/or licenses or certificates preferred.

• Working knowledge in DMPK and Bioanalysis.

* Travel requirements

• 0-10%

• Laboratory and office-based position.

Expected Hourly Range:

$35 - $50/hour.  The hourly salary offered will be contingent on assessment of candidate education level, background, and experience relative to the requirements of the position they are being considered for, as well as review of internal equity.

EEO Statement:

PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.

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