Research Associate II, Analytical Development & Quality Control (ADQC)

Role Summary

Seeking an experienced analytical chemist to join the Analytical Development & Quality Control (ADQC) group at the Research Associate II level. The ideal candidate will be familiar with HPLC and other chemistry techniques, possess a strong work ethic and solid technical background, demonstrate excellent oral and written communication skills, and have experience working in a GMP environment. The successful candidate will perform the following responsibilities with a high degree of independence and attention to detail.

Responsibilities

• Conduct routine and non-routine analysis of Raw and Starting material samples
• Review analytical data for compliance to SOPs
• Assemble and document data for quality review
• Present and participate in internal and external scientific meetings
• Revise and update SOPs as needed (e.g., analytical methods, equipment procedures, and material specifications)
• Conducts analytical investigations
• Applies knowledge of cGMP and GLP
• May develop and/or optimize analytical methods
• May author sections of scientific reports

Qualifications

• BS or MS degree in Chemistry or related field
• 2+ years of experience in analytical development and quality control role
• Practical knowledge of HPLC, MS, and GC, including operation of instrumentation
• Familiarity with GMP requirements, with hands-on GMP experience preferred
• Experience following SOPs and recording data in laboratory notebooks or data collection forms
• Ability to interpret experimental results and demonstrate good judgement in resolving issues / making recommendations
• Detail oriented with strong organizational skills
• Excellent written and verbal communication skills
• Ability to manage priorities and maintain aggressive timelines for multiple projects