Summary of Position

The Associate Director of Analytical Development will lead a team of analytical scientists and associates to develop common analytical methods for biologics (recombinant therapeutic proteins) process development and support subsequent clinical and/or commercial GMP manufacturing. As a core member of the Biopharmaceutical Development management team, the director will be responsible for the strategic planning and growth of analytical development functions.

Responsibilities

• Lead the development of HPLC methods (including RP, SEC, IEX etc.) for biologics (protein therapeutics) process development and support purposes.
• Lead the development of other common analytical methods such as electrophoresis, Western-Blot, ELISA, PCR, Endotoxin, host cell proteins, concentration, and cell-based assays.
• Manage process/technology transfer (externally from client or internally to Manufacturing) and provide manufacturing support and troubleshooting.
• Support IND/BLA CMC analytical process document preparation.
• Direct analytical innovation projects, new technology evaluation/ implementation, as well as conference presentation and journal publication.
• Contribute to department and corporate strategic planning and objectives setting.
• Mentor team members and manage department budget.
• Provide technical support to business and sales team and represent analytical development functions in client meeting.
• Author SOPs, protocols and technical reports and ensure adherence to high technical standards and compliance with applicable regulatory guidelines.
• Maintain accurate experimental records and results in laboratory notebook and/or datasheet.

Qualifications

• B.S., M.S. or PhD in Analytical Chemistry, Pharmaceutical Chemistry, or related discipline with strong hands-on experience with biologic/protein analytics in biopharmaceutical industry.
• Ph.D. with ≥5 years or MS with ≥8 years or BS with ≥10 years of industry experience in analytical method development, characterization, and qualification for HPLC and other analytical techniques for biologics.
• Able to analyze complex analytical problems, develop strategic initiatives and execute technical programs, and make recommendations to executive management.
• Knowledge on AAV analysis and characterization a plus.
• Ability to work in a fast pace environment, manage priorities, and maintain timelines for multiple projects is required.
• Strong knowledge in PAT technologies, GMP / ICH guidelines and CMC experience.
• Advanced cross-functional communication, written and presentation skills.
• Effective organizational and staff management skills.
• Proficient in statistical design of experiment and data analysis using JMP, Minitab, or Design Expert software.
• Flexible and results oriented.