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Job Description:-

• This position will work with senior staff under some supervision for analytical method development, validation, and transfer, stability testing and activities to support regulatory filing and clinical studies in compliance with all applicable guidelines.
• This position will be involved with conducting routine and advanced laboratory analysis and method development/validation. This position participates in preparation of laboratory Standard Operating Procedures (SOPs), methods, protocols, and reports.
• This position will be responsible for certain laboratory instrument maintenance/qualification to ensure they are compliant with established procedures and cGMP requirements. This position will maintain accuracy in scientific data and notebook writing.

• Participate analytical method development to characterize and ensure quality of the drug products.
• Perform analytical testing and generate data to understand and support formulation development of drug products.
• Perform stability testing and data trending.
• Perform analytical method validation and transfer with internal and external teams
• Write and review test methods, protocols and reports to accurately document completion of tasks.
• Prepare and present data summaries (written and oral) as necessary.
• Assist investigations, problem solving and troubleshooting. Write investigation reports.
• Operate and maintain all analytical instrumentation and equipment as per established procedures. Responsible for certain laboratory instrument maintenance and qualification.
• Write and revise SOPs.
• May provide training and assistance to other group members.
• Comply with all safety, regulatory and corporate procedures and policies to ensure that the laboratory is a safe and effective workplace.
• Performs other related assignments and duties as required and assigned.

• B.S. in Chemistry, Analytical Chemistry or Pharmaceutical Chemistry.
• Demonstrate some understanding, working knowledge of analytical chemistry, separation sciences, spectroscopy, and other hands-on analytical techniques.
• Good understanding and working knowledge of industry guidance (cGMP, GLP, etc.).
• Basic experience in pharmaceutical method development, validation and transfer.
• Skillful in HPLC, dissolution, disintegration, GC, FTIR, UV, KF and wet chemistry.
• Minimum 5-15 years of experience needed.
• Knowledge of Waters Empower chromatography software, Waters online HPLC Automated Dissolution and Fusion software.
• Familiar with Sotax Automated Sample Preparation Workstation
• Able to independently identify/observe problems and recommend solutions.