Analytical Development Scientist

Job Description The Analytical Development Scientist is responsible for performing laboratory testing on raw materials, in-process samples, and finished products, as well as supporting stability studies and validation activities for drug product development. This role operates in a cGMP environment and requires a strong understanding of pharmaceutical regulations and analytical best practices. Key Responsibilities

• Perform routine analytical testing, method validation, and process validation in accordance with SOPs, cGMP, GLP, GDP, and regulatory guidelines (FDA, DEA, OSHA)
• Follow applicable compendial and regulatory standards for analytical procedures, method development, validation, and transfer
• Troubleshoot laboratory methods and instrumentation, including HPLC and UPLC systems
• Utilize Empower 3 software to analyze, interpret, and report analytical data
• Complete assigned work efficiently while maintaining a strong focus on safety, quality, and timelines We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day.

We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.

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https://insightglobal.com/workforce-privacy-policy/. Skills and Requirements

• Identify and troubleshoot issues related to analytical methods, instrumentation, or product quality beyond routine testing
• Maintain working knowledge of USP/NF standards, stability testing requirements, and validation processes
• Collaborate effectively within a team-oriented R D environment
• Operate and maintain laboratory equipment such as HPLC, GC, dissolution systems, Karl Fischer titrators, UV/Vis, and FT-IR
• Demonstrate strong written and verbal communication skills
• Proficient in Microsoft Office (Word, Excel, Outlook)
• Able to work independently with minimal supervision