- Designs and implements labs at the manufacturing facility
- Has responsibility for Method Development, Qualification and Validation
- Responsible for routine testing and generation of Certificate of Analysis
- Develops functional capabilities within the department to keep pace with advances in technology and company growth
- Develops cooperative and strong working relationships with Manufacturing, Quality Assurance and MSAT to achieve company objectives
- Develops and coordinates the Quality Control laboratory activities and capabilities to provide timely, accurate and cGMP compliant testing of raw materials, in-process materials, final product and contract manufactured materials
- Ensures the proper investigation into the root cause of product failures, and assists in determining appropriate product disposition and/or process improvements
- Ensures that any internal and external laboratories comply with GMP standards
- Collaborates with MSAT and/or outside contract labs to ensure seamless method validation and transfer
- Participates in business sub-teams as a Subject Matter Expert (SME) to provide input on timeliness and to address analytical/microbiological related issues
- Such other responsibilities and duties as the company may from time to time assign.
- The Director of QC must demonstrate ability to lead in a collaborative environment with a positive leadership style and a hands-on approach that emphasizes team work, collaboration, influencing, motivating, and consensus and team building. Good critical thinking, deductive reasoning, and decision-making skills are essential. The ideal candidate should have experience designing and implementing QC laboratories and establishing standard operating procedures.
- Bachelor's Degree in Chemistry, Biology or related sciences
- Minimum 12 years of experience in pharmaceutical testing laboratory
- 8+ years of direct supervisory experience
- Comprehensive knowledge of biological and microbial analysis, manufacturing operations, GMP's and the theories and general principles behind them
- Comprehensive knowledge of compliance with cGMP regulations
- Understanding of laboratory equipment such as qPCR, Flow Cytometer, UV/Vis Spectrophotometer, Densitometer, Gel Imager, pH, Osmometer, etc.
- Understanding and experience with relevant analytical and microbiological testing, methods development/validation, and environmental monitoring programs required to meet all regulatory requirements
- Strong project management skills