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PDS Tech Inc Scientist I in Frederick, Maryland

PDS Tech is seeking candidates for a Scientist position in Frederick, MD

The ideal candidate would support lab automation and validation throughout manufacturing. The successful candidate will work in cross-functional teams to drive excellence in process design, new-product-introduction, technology transfer, problem solving, and root-cause analysis. The scientist will be involved execution of both method and process validations as well as continuous improvement efforts.

Essential Functions:

  • Provide technical support to enhance manufacturing robustness and repeatability

  • Support continuous improvement, new product development and method transfers.

  • Plan, schedule and performs testing of processes and reagents utilizing techniques such as fluorescent based assays, qPCR, dPCR and NGS

  • Participate in the design and execution of method and process validations.

  • Analyze data and communicate results in a team environment.

  • Participate in the drafting manufacturing documentation such as production SOPs

  • Troubleshoot issues/conduct root cause analysis and to recommend and implement corrective actions for processes

  • Maintains accurate records and documentation; responsible for the quality of project deliverables and documentation

Education /Experience Requirements

  • Bachelor’s degree (or AS + relevant experience) in Biology, Chemistry, Biochemistry, Molecular Biology or other related life science discipline in Molecular Biology, Biochemistry or related field.

  • Minimum of 1+ years industry experience (work with FDA regulated products preferred)

  • Strong bench skills and experimental design

  • Experience with analytical method and process validation in a regulated environment

  • Strong systems/process orientation with demonstrated analytical thinking, organizational skills and problem solving skills

Experience in completing documentation (GDP) and data collection in a GMP laboratory

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.