Principal Scientist -Bridgewater/NJ
Bridgewater, New Jersey
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Provide bio-marker support to progress drug development programs, initially focused in hematological diseases. The incumbent is expected to oversee routine and complex bio-marker experiments conducted in internal or external laboratories. This includes bio-marker assay development, troubleshooting and validation, quality checking of data and return of data and reports to project teams. The incumbent will promote the conduct of experiments with high quality and within expected timelines. Incumbent is expected to contribute to plans for quality bio-marker sample collection, shipping, banking and analysis. The incumbent will act as a resource for current and emerging bio-marker technologies. Participation in TMED Working Groups and project team Translational Medicine groups is expected.
Essential Job Duties and Responsibilities
- Must have a thorough understanding of standard and emerging bio-marker assay technologies for development and validation of complex assays, including capability to identify potential issues and trouble-shoot assays when problems are identified.
- Assist project teams on selection of best assay technologies to support project objectives, with subsequent implementation of those technologies.
- Serve as BCB Lead to support project teams with bio-marker activities.
- Contribute to achievement of team bio-marker objectives with high quality and within timelines. Develop productive relationships with personnel in internal and external groups involved in bio-marker activities.
- Provide scientific input and oversight on bio-marker sample collection, shipment and storage, sample analysis, and return of data.
- Contribute to high quality, timeliness, and following of regulatory requirements with internal laboratories and external service providers.
- Participate in meetings and other activities of project teams, CTTs, working groups, and other relevant groups as needed to contribute to projects.
- In support of projects and innovation, assist BCB, TMED and other groups regarding biomarker-specific scientific, operational and regulatory issues and opportunities.
Required Educational Background and Job-Related Experience
- Ph.D. in biochemistry, immunology, pharmacology, genetics, bio-analytics, or related scientific discipline with 5 or more years of industry experience, or a Masters Degree with 7 or more years of experience.
- Experience with bio-marker assay development and validation, especially for large molecules or nucleic acids.
- A diverse skill-set in bio-analytical assay development methodologies such as ligand binding (ELISA, MSD, etc.), multiplexed bio-marker analysis, and enzymatic activity assays.
Knowledge and Skills Required
- Strong interpersonal and organizational skills.
- Familiar with regulatory expectations (FDA, EMA, Asia-Pacific) and industry best practices in analytical assay development and validation of bio-marker assays.
- Strong desire to continue to develop scientific expertise in bio-marker technologies and utilization in drug development.
Knowledge and Skills Desirable but not Essential
- Emphasis on development of treatments for hematological diseases considered a plus.
- Prior experience serving on drug development project teams.
- Experience with bioinformatics, quality, regulatory, outsourcing, or drug development.
- Experience with small molecule drug metabolism and pharmacokinetics.
- Experience with pharmacogenomics.
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