Scientist I - The primary objective of the Scientist I position is to support early stage product development through commercialization efforts. The Scientist I 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 I will work under the guidance of more senior staff to develop the ability to work independently. The Scientist I may be required to write or revise SOPs, analytical procedures, analysis reports, validation documents, etc.
Scientist II - The primary objective of the Scientist II 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. The Scientist II may be assigned the responsibility of specialized compliance functions within the laboratory, such as controlled substance or reference standard management. The Scientist II 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.
Scientist III - The Scientist III position is a highly experienced chemist within the Analytical Development laboratory with a strong working knowledge of both analytical and organic chemistry. The purpose of this position is to support early stage product development through commercialization. The Scientist III will be expected to support/troubleshoot the formulation and manufacturing processes, identify potential negative interactions, degradation pathways, subsequent impurities, and degradants. The Scientist III would also be expected to perform duties including, but not limited to, the qualification of analytical instrumentation, method development and validation, and method transfer activities.
Major Duties/Responsibilities (Scientist I)
- Project technical support.
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Accountability for the execution of analytical deliverables.
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Communicates project obstacles.
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Provides proactive communication on the technical aspects of the project to all internal stakeholders.
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May 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.
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Documents laboratory activities including notebook/worksheet, electronic notebook, and LIMS entries according to procedures that define laboratory documentation practices.
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Processes electronic data using procedures that ensure data integrity and security.
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Performs and documents daily standardization and performance verifications on laboratory equipment.
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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.
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Performs controlled substance chain of custody documentation and reconciliation.
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Evaluates and interprets test and experimental data, draws conclusions based on results, and documents and communicates work appropriately.
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Resolves technical issues and interprets and uses experimental data to expand on assignments whenever possible.
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Troubleshoots technical procedures, methodology and instrumentation.
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Transcribes results onto analysis reports, LIMS or stability summary sheets.
- Develops subject matter expertise with analytical technology transfer activities May author/review analytical protocols, SOPs, reports and related documentation.
- Learns to author/review laboratory investigations. Conducts investigations, determines root cause and documents results, as needed, in compliance with SOPs.
- 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.
Major Duties/Responsibilities (Scientist II)
· 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.
Major Duties/Responsibilities (Scientist III)
· Utilize knowledge of mechanistic organic chemistry to identify issues in drug product formulations
· Predict impurity profiles and degradation pathways for active pharmaceutical ingredients and drug product by using the structures of active pharmaceutical ingredients and excipients
· Working in line with the scope of the project, participate in or lead the design/evaluation and execution of routine and more complex testing or studies.
· Provide analytical leadership of one or more client projects and represent the function on client project team(s). Present interpreted results and updates to internally and to individual clients in a timely and professional manner.
· 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.
· Review all relevant data (stability, specifications) in order to identify and report trends or OOS results.
· Participate in or lead problem solving (scientific, equipment, process). Assist in trouble shooting and investigations as required.
· Perform testing and data peer review in accordance with written procedures for stability, clinical, formulation development, and method development/validation.
· 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.
· Assists laboratory management with acquisition, upgrade and qualification of instruments.
Lead or Supervisory Responsibilities
Indicate the type and scope of responsibilities of this position.
May lead work of others who perform essentially the same work. May organize, set priorities, schedule and review work, but has no responsibility to hire, terminate, review performance or make pay decisions.
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