Scientist

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

Requirements

• BS or MS in chemistry, organic chemistry, or biochemistry
• Minimum of 2 - 3 years relevant experience in an analytical laboratory
• Ability to think beyond routine analysis of samples to detect issues with the method, product, or instrumentation
• Basic knowledge of USP/NF, Product Stability requirements, and Process and Method validation.
• Ability to integrate into team-based projects
• Experience with laboratory instrumentation such as HPLC, Dissolution Bath, GC, Karl Fischer titrator, UV/Vis, and FT-IR Spectrometer.
• Strong interpersonal communication and writing skills
• Competency in Microsoft Office Suite

Compensation: Ranges from $75,000 - $95,000 a year annual salary. Bonus opportunities are available. Exact compensation may vary based on several factors, including skills, experience, and education. Benefit packages for this role include: Benefit packages for this role may include healthcare insurance offerings and paid leave as provided by applicable law.