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DMPK Scientist, Bioanalytical

2 months ago

Exton, United States Frontage Laboratories Full time
Job DescriptionJob 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 department of Drug Metabolism and Pharmacokinetics (DMPK) at Frontage is seeking a highly motivated candidate with biology or chemistry background (BS, MS or PhD). This position requires an understanding of bioanalytical techniques. This person will work as a member of our DMPK drug development group and will be responsible for performing a variety of drug analysis of PK studies with guidance from senior members of the team. It is expected the individual selected for this position will receive appropriate trainings in handling radioactive compounds/samples and in the operation of analytical instruments such as HPLC and mass spectrometers.

Responsibilities

• Develop bioanalytical (especially) LC/MS/MS methods for discovery and development compounds

• Verify and qualify LC/MS/MS methods as needed for studies requiring more stringent bio-analytical criteria

• Work in a high pace environment in developing methods to analyze biological samples (e.g. plasma) from PK and in vitro metabolism studies requiring quantitative information.

• Assist in the preparation of study reports for studies involving bioanalysis of samples

• Ensure that all studies are conducted in a timely manner while maintaining highest quality of data

• 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.

• Work with Study Directors/Sponsors in study design, protocol preparation, and overseeing conduct of studies if needed.

• Effectively manage numerous tasks/projects simultaneously to meet internal/external deadlines while maintaining organizational integration within the DMPK team.

Requirements

• BS or MS or PhD with 0-3 years relevant experience in any of the pharmaceutical sciences including pharmacokinetics, in vitro and in vivo metabolism, mass spectrometry or analytical chemistry.

• Knowledge of LC/MS/MS analytical techniques will be a plus.

• Broad post-graduate experience in DMPK (for PhD positions) as demonstrated through publications will be a plus but not essential.

• Compensation commensurate with education and the experience.