R&D Analytical Chemist II

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Job description

Nature and scope

This R&D position will be responsible for testing of raw materials, finished products, stability samples, using existing HPLC, GC, IC, UV analytical methods.

Essential duties and Responsibilities

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.

• Perform analytical testing of raw materials, finished product, stability samples, and lab batch samples using HPLC, GC, IC, and UV.
• Support the Intermediate Precision and Crossover Studies on analytical method validations.
• Support the activities to develop analytical methods to assess the purity, potency and stability of drug substances and finished products.
• Analytical activities involved in method transfers from Research and Development to either Quality Control or external analytical laboratory.
• Provide analytical testing support to formulation scientist on pertinent development batches/studies in the lab.
• Support cleaning validation activities.
• Ensure all work is performed and documented in accordance with existing company policies, procedures, current Good Manufacturing Practices, and health & safety requirements.
• Maintain clean and safe work environment in the laboratory.
• Generate stability tables for exhibit batches.

• Perform any other tasks/duties as assigned by management.

• We all must embrace the QUALITY culture.

Qualifications and Requirements

• B.S. in Chemistry or equivalent required.
• Minimum 1-2 years relevant experience required.
• Adequate knowledge of chromatographic techniques (HPLC, GC and TLC), spectroscopic (UV-VIS and FTIR), dissolution, pH, viscosity, and moisture measurement.
• Excellent knowledge of wet chemical analysis.
• Excellent organizational, interpersonal and communication skills (oral and written).
• Proficiency in Microsoft Office word and excel required.

Physical Environment and Physical Requirements

• While performing duties of the job, incumbent is occasionally required to stand; walk; sit; use hands to finger, handle or feel objects, tools or controls; reach with hands and arms; balance; talk and hear.

• Physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees.
• Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly.
• Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision.

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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