Essential Functions:

• Manage R&D ADQC stability programs, such as but not limited to, providing sampling. volume forecast, coordinating with stability group on stability set-down and monitoring each stability pull-point.
• Manage in-house routine testing, such as stability and release testing, characterization, in-process samples analysis and reference standard qualification. Responsible for the overall quality and compliance of all the testing.  
• Provide technical direction, mentorship and coaching to the analytical development team.
• Lead the design and interpretation of experiments to analyze raw materials.
• Keep accurate and detailed records of experiments in laboratory notebooks.
• Summarize data and communicate to cross functional team such as stability, PD and PM.
• Represent ADQC to attend X-Functional lab operation alignment meeting led by facility.
• Work within a team environment and provide support to further team objectives.

Requirements:

• PhD in Chemistry, Analytical Chemistry, Biochemistry, or related field with 8+ years relevant industry experience; MS or BS with 15+ years of industry experience in Pharma/ Biotech industry required.
• Proven leadership skills.
• Outstanding organization and planning skills.
• Must be a strong scientific leader who can guide scientists with clear goals of developing analytical methods, and critically and skillfully review and assess analytical methods under development. May need to provide direction for troubleshooting various issues during method development.
• Proven track record of analytical development leadership for biologics and small molecules, experience with vaccines, carbohydrate, or conjugates is a plus.
• Extensive expertise in U/HPLC, CE, SDS-PAGE, mass spectrometry, and other analytical technologies as applied to protein analytical method development, trouble shooting and validation for GMP release and stability testing.
• Knowledge of capillary electrophoresis and/or experience in use of such would be a plus.
• Experience in protein, carbohydrate, and conjugates analysis is highly desired, for example hands on experience and theoretical understanding of HPAEC-PAD, HPLC/UV/FLD, SEC-LC, SEC-MALS, and colorimetric assays are highly desired.
• Attention to detail and excellent skills in record keeping / documentation. Critical thinking and ability to analyze data.
• Strong interpersonal skills: ability to communicate effectively both verbally and in written formats.
• Ability to work with minimum supervision in a fast-paced, cross-functional environment and collaborate effectively with other team members. Eagerness and ability to learn and understand new concepts with ease.