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Analytical Development Director - Bloomington, United States - Aegis Worldwide
Description
Job Description
Job DescriptionThe primary objective of the Analytical Development Director position is to support early stage product development through commercialization. The Scientist II will be expected to perform duties including, but not limited to, routine analytical testing, method development and validation, method transfer, and equipment purchase and qualifications. The Scientist II is expected to work independently with minimal supervision. This individual may be assigned the responsibility of specialized compliance functions within the laboratory, such as controlled substance or reference standard management. This person will be required to write or revise SOPs, analytical procedures, analysis reports, validation documents, etc. May serve as a technical leader for internal/client based projects.
Major Duties/Responsibilities
· Project technical leader responsibilities.
o Accountability for the execution of analytical deliverables.
o Communicates project obstacles.
o Provides proactive communication on the technical aspects of the project to all internal stakeholders.
o Key technical interface with clients during meetings and teleconferences.
· Perform testing and data peer review in accordance with written procedures for stability, clinical, formulation development, and method development/validation.
o Documents laboratory activities including notebook/worksheet, electronic notebook, and LIMS entries according to procedures that define laboratory documentation practices.
o Processes electronic data using procedures that ensure data integrity and security.
o Performs and documents daily standardization and performance verifications on laboratory equipment.
o Reviews and countersigns (as appropriate) logbooks, notebooks and worksheets for the purpose of verifying compliance with written procedures, good documentation practices, data integrity and accuracy of calculations.
o Performs controlled substance chain of custody documentation and reconciliation.
o Evaluates and interprets test and experimental data, draws conclusions based on results, and documents and communicates work appropriately.
o Resolves technical issues and interprets and uses experimental data to expand on assignments whenever possible.
o Troubleshoots technical procedures, methodology and instrumentation.
o Transcribes results onto analysis reports, LIMS or stability summary sheets.
· Performs method development/validation and method transfer.
o Develops analytical methods for dissolution and chromatographic analysis.
o Authors/reviews validation and method transfer protocols.
o Acts as subject matter expert for analytical technology transfer.
· Authors/reviews analytical protocols, SOPs, reports and related documentation.
· Authors/reviews laboratory investigations. Conducts investigations, determines root cause and documents results, as needed, in compliance with SOPs.
· Ensures laboratory reference standards are maintained in compliance with controlled substance and site SOPs and the site EH&S manual.
· Assists with periodic maintenance/calibration of laboratory equipment.
· Assists laboratory management with acquisition, upgrade and qualification of instruments.
· Complies with site wide and departmental procedures including but not limited to change control, documentation, deviation reporting, cGMP compliance, safety and electronic data security.
