Primary Location
: USA-North Carolina-DurhamOrganization
: USA02 - US Clinical Development Svcs
Purpose:
Will
contribute to developing, refining and optimizing molecular genomic test
procedures utilizing next-generation sequencing and other modern
molecular biology techniques at EA, a Quintiles Company.
Responsibilities:
- Adhere to all EA policies, procedures and employee handbook contents.
- Working primarily under the supervision of a development scientist, will develop and optimize molecular genomic test procedures and will cooperate with the R&D team as well as other functional groups including Statistics and Bioinformatics to specify and develop supporting infrastructure for the test procedures.
- Maintain detailed records of all laboratory work performed.
- Carry out testing, verification and/or validation of new technology platforms and test procedures and will contribute towards corresponding development plans and summary reports that adhere to Quality Systems requirements.
- Help estimate capacity, costs, personnel, equipment, reagents and time requirements for test procedures and/or technology platforms being developed or implemented, including ongoing calibration and maintenance where required.
- Prepare newly developed test procedures for transition to Laboratory Operations, coordinate with Operations to finalize training recommendations and requirements, and train personnel on new test procedures as needed.
- Function in a team environment, recognizing that priorities will shift according to business needs and maintain a flexible work schedule.
- Other duties, as assigned.
Required Knowledge, Skills, and Abilities:
- Working knowledge of GLP, CLIA and HIPAA requirements.
- Demonstrated expertise in contemporary genomic technologies.
- Excellent planning and organizational skills, and close attention to detail are essential.
- Capable of contributing to multiple projects simultaneously.
- Good oral and written communications skills.
- Proficient user of standard office productivity software such as Microsoft Word, Excel and PowerPoint, along with basic statistical analysis.
Qualifications
Minimum Required Education and Experience:
-
BS in Molecular Genetics or related field.
-
Minimum of 2 years molecular biology lab experience, including direct experience with genomic technologies.
-
Experience in a clinical laboratory operating under GLP and/or CLIA guidelines is preferred.
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