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You will be updated with latest job alerts via emailPosition Summary: Develop stabilityindicating methods. Design and conduct routine laboratory analysis using various analytical instruments and software such as HPLC UPLC ICP and UVVis.
Responsibilities:
Responsibilities include but are not limited to:
Knowledge of USP and FDA requirements.
Develop stabilityindicating methods for Active Pharmaceutical Ingredients (API) and Dietary Supplement products.
Generate method validation protocols.
Execute methods validation and methods transfer.
Generate method validation reports and analytical methods.
Design and conduct full analysis of Dietary supplements and Active Pharmaceutical Ingredients (API) products and their impurities.
Conduct assay content uniformity dissolution inprocess blend and blend uniformity of newly developed and stability samples in support of formulation and process development.
Prepare result documentation for department and general review.
Identify and resolve problems with analytical methods and provide troubleshooting on instrumentation.
Conduct Performance Qualification (PQ) on various instruments.
Provide leadership guidance and handson training to new employees and provide technical support to other departments.
Effectively communicate information in concise reports.
Other responsibilities as assigned by Senior Management.
Requirements:
Education and Experience:
Bachelors degree in chemistry or analytical chemistry with 45 years of pharmaceutical experience OR
Masters degree or Ph.D. in chemistry or analytical chemistry with 34 years of pharmaceutical experience
Instrumentation and Computer Experience:
Instrumentation: HPLC UPLC ICP GC FTIR UV Dissolution pH TOC and Karl Fischer.
Computer programs: Empower 13 EZ Chrome Elite WindLab ChemStation Microsoft Word Excel and Outlook.
Work Conditions:
Hours/Travel maybe subject to changed based on management/company discretion. Work location are subject to change as needed to meet business requirements. While performing the duties of this job the employee is regularly required to stoop kneel crouch stand bend sit talk hear or walk for long periods. The employee may lift and/or move up to 50 lbs. Specific vision abilities required by this job include close vision distance vision depth perception and ability to adjust focus.
Supervisory Responsibilities: None
Personal Protective Equipment or Attire Required for Position: As needed
Salary Range: $70000 $90000 per year
Remote Work :
No
Employment Type :
Fulltime
Full-time