We're seeking an experienced Quality Control professional to lead analytical activities in a fast-paced GMP-regulated biopharma environment.
Key Responsibilities:
1. Supervise Analytical Operations: Oversee all QC/ARD Laboratory activities, ensuring timely execution of testing.
2. Manage Lab Testing & Sample Coordination: Ensure accurate and efficient sample testing for raw materials, in-process, and finished products.
3. Data Review & Compliance: Review analytical data, ensuring it meets ICH, USP, and EP regulatory standards.
4. Method Development & Validation: Support analytical method transfers, validation, and troubleshooting (HPLC, GC, UV, FTIR, etc.).
5. Lead & Develop a High-Performing Team: Train, mentor, and manage analysts, ensuring compliance with GMP and lab best practices.
6. Audit & Compliance Readiness: Ensure the lab is always audit-ready, managing CAPAs, deviations, and change control processes.
7. Resource & Vendor Management: Oversee lab supplies, equipment calibration, and vendor qualification.
Requirements:
* BSc/MSc in Chemistry, Biochemistry, or a related field
* 5+ years of QC experience in a GMP-regulated laboratory (2+ years in a supervisory role)
* Strong hands-on experience with HPLC, GC, UV-Vis, FTIR, dissolution, and wet chemistry techniques
* Expertise in method validation, troubleshooting, and analytical method transfers
* Leadership, problem-solving, and excellent communication skills
About Us:
* Opportunity to lead and develop a QC team in a growing biopharma company
* Work with cutting-edge analytical instrumentation and techniques
* Be part of a high-performing, cross-functional team in a GMP environment
* Competitive salary, benefits, and career growth opportunities