Senior DMPK Scientist / Associate Director DMPK

Job Description
ABOUT

Frontage Laboratories is a CRO / Clinical Research Organization providing integrated, science-driven, product development services throughout the drug discovery and development process to enable life science companies to achieve their drug development goals. We have enabled many innovator, generic and consumer health companies of all sizes to file IND, NDA, ANDA, BLA and 505(b)(2) submissions in global markets allowing for successful development of important therapies and products for patients. We are committed to providing rigorous scientific expertise to ensure the highest quality and compliance. We have successfully assisted clients to advance hundreds of molecules through development to commercial launch in global markets. Come and join us to make a world of difference.

DMPK

The DMPK/ Drug Metabolism and Pharmacokinetics group is dedicated to enabling the discovery, development, and commercialization of safe and effective medicines by elucidating the absorption, distribution, metabolism, excretion and pharmacokinetic properties of small molecule drug candidates. We accomplish this through the application of state-of-the-art technologies and sciences of bioanalysis, drug metabolism, drug transport and pharmacokinetics. The DMPK group works in close partnership with disciplines such as medicinal chemistry, pharmacology, toxicology, pharmaceutical sciences, clinical pharmacology and regulatory to optimize leads, select clinical candidates, conduct preclinical development studies, support clinical evaluation and contribute to IND and NDA filings.

Position Summary

The Senior DMPK Scientist position combines the knowledge of several scientific disciplines, such as biochemistry, drug metabolism/ pharmacokinetics, and analytical chemistry. Experience in and knowledge of ADME studies in support of drug discovery and development is critical for this position.

Responsibilities

• Responsible for conducting in vitro and in vivo metabolism studies using radiolabeled and non-radiolabeled compounds.
• Analyze samples using HPLC coupled to radioactivity and mass spectral detectors.
• Use LSC and sample oxidizers to generate data for mass balance studies.
• Ensure the appropriate equipment/instruments are calibrated and records maintained documenting any maintenance, repairs and upgrades.
• Analyze samples using LC/MS/MS (Orbitrap, ion trap, triple stage quadrupole instruments)

• Prepare written reports for clients upon completion of each task.

• Maintain a record of all studies in appropriate notebooks as per Frontage SOPs.
• Follow Frontage SOPs, DMPK guidelines, and study protocols while conducting studies. Ensure all laboratory operation and record-keeping are of high quality and compliant with Frontage SOPs or other applicable regulations.
• Ensure that all studies are conducted in a timely manner while maintaining highest quality of data.
• Work with Sponsors in study design, protocol preparation, and overseeing conduct of studies.
• Effectively manage numerous tasks/projects simultaneously to meet internal/external deadlines while maintaining organizational integration within the DMPK team.

Requirements

• PhD or MS plus 5 + years relevant industry experience in biochemistry, in vitro DMPK or similar discipline with coursework and research relevant to pharmacokinetics and/or drug metabolism.
• Significant experience and leadership in conducting metabolism studies with radiolabeled compounds.
• Familiarity with GLP compliance and EPA rules/regulations.
• Knowledge of LC/MS/MS analytical techniques will be a plus.
• Broad post-graduate experience in DMPK as demonstrated through publications will be a plus but not essential.

Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.