Associate Director – Technical Services/Manufacturing Science

Responsibilities

• Lead a technically comprehensive organization to provide oversight of biological and bioconjugate manufacturing processes in collaboration with engineering, IT, operations and quality functions.
• Ensure manufacturing processes run reliably in a state control through process monitoring supported through technical knowledge.
• Support site leadership to build a diverse and capable TS/MS organization with the necessary capability, capacity and culture to operate the facility to the highest standards of excellence.
• Lead, develop and retain a high-performing team, fostering a culture of technical excellence, curiosity, accountability and continuous improvement.
• Determine TS/MS staffing and resource needs to support process operations through facility startup to enable successful process qualifications and validations.
• Support the development and implementation of robust control strategies to ensure regulatory compliance and operational excellence through lean principles in a digitally native plant.
• Review and approve documentation including procedures, deviation investigations, technical reports, change controls, qualification and validation protocols and summary reports.
• Support the project team to deliver the facility to the site lead team ready to operate and on schedule.

  Requirements

  • BS, MS, or PhD in biology, biochemistry, chemistry, chemical engineering, or a related scientific discipline.
  • Minimum of 10+ years of experience in the biopharmaceutical industry, with at least 5 years in a people leadership role.
  • Proficient in English.

  Additional Skills/Preferences

  • Knowledge of manufacturing processes, lab scale models, and unit operations used in the manufacturing of biotech products.
  • Knowledge of laboratory scale models and commercial scale biotech manufacturing processes.
  • Strong written and verbal communication skills.
  • Ability to work on own initiative and as part process team consisting of a diverse group of management, production/science and engineering professionals.
  • Ability to respond quickly and proactively to changing priorities within a limited timeline.