Analytical Laboratory Scientist

Job Title: Analytical Laboratory Scientist – Compounded Pharmacy Products

Employment Type: Full-Time

Compensation:

• Salary: $120,000 – $180,000 annually (DOE)
• Competitive benefits package

About the Role:

We are hiring on behalf of our client, who is a leader in the pharmaceutical compounding industry, specializing in 503A and 503B products.

The Analytical Laboratory Scientist will play a critical role in ensuring data integrity and regulatory compliance across sterility, potency, and stability testing. This position requires a high-impact scientist capable of leading analytical and microbiological testing, method development, and investigations while maintaining rigorous documentation in compliance with cGMP standards.

Key focus areas include:

• Analytical & Microbiological Testing – Execute potency, purity, sterility, and endotoxin testing using HPLC, LC-MS/MS, and rapid microbiology tools (USP <71>, <85>)
• Method Development – Develop and validate analytical methods aligned with USP and FDA expectations
• Instrumentation Management – Operate and maintain advanced lab systems, including LC-MS/MS and Scan RDI
• Compliance & Documentation – Maintain documentation following cGMP and ALCOA+ principles
• Investigations – Lead OOS and OOT investigations, implement CAPAs, and identify root causes

Qualifications:

• Bachelor’s degree in Chemistry, Biochemistry, or related scientific field
• 2–5+ years of experience in pharmaceutical or compounding laboratory environments
• Hands-on expertise with HPLC and/or LC-MS/MS
• Strong knowledge of USP standards (<795>, <797>, <800>) and FDA 503A/503B guidance

Requirements:

• Ability to maintain meticulous documentation and adhere to regulatory compliance standards
• Strong analytical and problem-solving skills
• Experience with sterility, potency, and stability testing of compounded drug products
• Self-motivated and capable of working independently in a laboratory environment

If you are a highly skilled analytical scientist ready to take ownership of laboratory testing and regulatory compliance, we encourage you to apply today!