Head of Quality Control
2 months ago
Head of Analytical Development and Quality Control
My client are a small biologics CDMO in Boston focused on both DS and DP. Due to company growth and new projects, we are looking for an experienced individual min both Quality Control and Analytical Development.
Position responsibilities:
- Supervise daily department operations, ensuring department personnel execute their responsibilities in strict accordance with relevant regulatory guidelines;
- Taking guidance from the requirements of the good laboratory practice (GLP) and GMP, standard operating procedures, specifications and other documentation for the quality assessment and control products;
- Update of the quality control policy, review and approval of standard operating procedures, instructions, specifications, analytical protocols, stability programs;
- Organize teamwork, hire, train and develop personnel, plan department budget;
- Ensure that the calibration and/or validation of equipment, instrumentation and analytical methods required for the product analysis have been performed;
- Seek process innovation and continuous process improvement in laboratory area;
- Lead department initiatives and projects.
- Leading the team of 4-6 people via providing expertise, scientific support in the following key activities of the department;
Position requirements:
- 7-10 years of extensive relevant Analytical Development and Quality Control experience;
- Good understanding of pharmaceutical manufacturing operations and/ or CDMO business;
- University degree in natural sciences or another field of science and having knowledge in biology/biotechnology/chemistry;
- Proven direct supervisory experience, preferably in a laboratory;
- Demonstrate knowledge of cGMP requirements and practices including extensive knowledge of the USP and FDA Guidance Documents relating to the pharmaceutical Quality Control Laboratory;
- Demonstrate competency in the operation, calibration and qualification of common analytical instrumentation e.g., HPLC, Dissolution, GC, FTIR, Electro Chemistry (DME), UV/Vis and other USP instrumental and Wet chemistry technologies used in pharmaceutical laboratory;
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