Scientist II; Analytical R&D

Responsibilities

• 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 employees and provide technical support to other departments.
• Effectively communicate information in concise reports.

Requirements

• Bachelor’s degree in chemistry or analytical chemistry with 4-7 years of pharmaceutical experience OR Master’s degree or Ph.D. in chemistry or analytical chemistry with 1-4 years of pharmaceutical experience.
• Instrumentation and Computer Experience: 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.

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.

Salary

$70,000.00 - $90,000.00