Develop stability-indicating methods. Design and conduct routine laboratory analysis using various analytical instruments and software such as HPLC, UPLC, ICP, and UV-Vis.
Responsibilities: Responsibilities include, but are not limited to:
· Knowledge of USP and FDA requirements.
· Develop stability-indicating 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, in-process 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 hands-on training to new employee and provide technical support to other departments.
· Effectively communicate information in concise reports.
· Other responsibilities as assigned by Senior Management.
Education and Experience:
· Bachelor’s degree in chemistry or analytical chemistry
. 4-5 years of pharmaceutical experience.
· Master’s degree or Ph.D. in chemistry or analytical chemistry with
. 3-4 years of pharmaceutical experience
Instrumentation and Computer Experience
· Instrumentation: HPLC, UPLC, ICP, GC, FT-IR, UV, Dissolution, pH, TOC and Karl Fischer.
· Computer programs: Empower 1-3, EZ Chrome Elite, WindLab, ChemStation, Microsoft word, Excel and outlook.
· 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.
· For exempt employees, casual or incidental overtime worked is not compensable. When these extra efforts are either infrequent or of short duration, it is expected that exempt Employees will consider these extra hours per day, part of their professional employee/Company relationship and extend their efforts without additional compensation.
Personnel Protective Equipment or Attire Required for Position:
· As needed