Method Development Group Leader

Method Development Group Leader

24 Dec 2024
Indiana, Indianapolis, 46201 Indianapolis USA

Method Development Group Leader

Responsibilities include, but are not limited to, the following:Lead a group of scientists to support non-routine analytical activities (method development, optimization, qualification/characterization of stability indicating methods) for early phase pharmaceutical small to medium molecules with pre-set timelines using instrumentation such as, but not limited to, UPLC/HPLC, Dissolution, GC, Thermogravimetric DSC/TGA, and KF titration.Lead pharmaceutical drug development program as analytical development scientist to collaborate with other departments and support formulation development and manufacturing activities with pre-set timelines.Participate in technical discussions with project leads to recommend alternatives, research new methods/techniques and discuss potential solutions to problems.Plan critical laboratory experiments to investigate aberrant results, determine root cause and recommend action planWrite Standard Operating Procedures (SOPs), assist in generating technical reports, prepare data for presentations/technical discussions and transfer methods internally and externallyPrepare method protocols, & technical reports for characterization of analytical methods based on separation techniques (HPLC, UPLC, GC), Spectro-analytical technique (Ultraviolet-Visible Spectrophotometry) and dissolution testingAssist and mentor junior level scientists on analytical techniques and troubleshooting issues.Ensure project deliverables are scientifically accurate and meet timeline expectationsAssist executive management in strategic planning, business development and expansion initiativesComply with all laboratory safety guidelines including Personal Protective Equipments (PPEs)Maintain general cleanliness of the lab, including personal bench space and common use areas

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