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!