PRIMARY DUTIES AND RESPONSIBILITIES: 

• Perform analytical tests (wet chemistry, assay, impurity/degradant, dissolution and residual solvents in raw materials and finished products according to USP or in-house methods.
• Perform method validation/verification for API and drug products.
• Comply with cGMP regulations and follow all standard operating procedures or with manager’s instructions.
• Maintain and troubleshoot laboratory equipment and analytical instrumentation within level of experience.
• Review peer’s notebooks.
• Coordinate with Quality Control department to smoothly transfer the methods.
• Work with Sr. chemist to write method validation protocols and reports.

ASSOCIATED DUTIES AND RESPONSIBILITIES:  

• Perform and/or assist with equipment calibrations and qualification
• Other related duties as required.

REQUIRED SKILLS, ABILITIES, AND QUALIFICATIONS: (INCLUDE LEVEL OF EDUCATION, YEARS / TYPE OF EXPERIENCE, CERTIFICATIONS, ETC.)  

• 4 year degree in chemistry or related discipline.
• 2 – 4 years experience with analytical instrumentation, such as HPLC/ GC and dissolution apparatus.
• Ability to follow standard operating procedures.
• Solid working knowledge of MS Office programs.
• Strong communication skills, both written and verbal.
• Ability to organize, prioritize and effectively perform concurrent tasks with minimal supervision.
• Strong attention to detail.
• Desire and ability to work in a positive team environment.