Subject Matter Expert in Molecular Biology

Job Description

The Subject Matter Expert in Molecular Biology is a team member in the Large Molecule & Advanced Therapy Medicinal Products Services group.

Critical Performance Areas

■    Develop, validate, and transfer analytical methods for the analysis of drugs using molecular biology methods for customers

■    Conduct method optimization and troubleshooting to ensure accuracy, precision, and robustness of analytical methods

■    Generate and interpret data to support method development, validation, and transfer

Essential Job Functions

■    Work collaboratively with cross-functional teams and customers

■    Prepare and review technical documents, including analytical method development and validation reports, protocols, and analytical test procedures

■    Organize, participate in, and review routine testing

■    Perform cGMP investigations for quality events such as deviations, non-conformities, Out-of-Specification results, and change controls

■    Train technicians and peers under cGMP practices

■    Keep abreast of the latest developments in analytical technology and contribute to the continuous improvement of analytical processes and methods

Requirements

■    Master’s Degree or Ph.D. in Biology or Biochemistry with strong experience in Molecular Biology

■    Experience in enzyme immunoassays (ELISA), PCR, next generation DNA sequencing, and other emerging technologies

■    Experience working in a cGMP or GLP environment

Other Desired Skills/Abilities

■    Excellent organizational skills and ability to work independently as well as collaboratively in a team environment

■    Excellent written and verbal communication skills and ability to prepare technical reports and presentations

■    High discipline and sense of responsibility

■    English-language fluency

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