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Associate Director


Analytical Development

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Peng JiaoCEO, Boston Institute of Biotechnology

About the job

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.
Staff
50
Projects Completed
130
Years of Experience
20
Growth YoY
247

Apply Now

Please email your resume and why you believe you are a good fit for this position directly to contactus@bostonbib.com Thank you!

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