Associate Director – Technical Services/Manufacturing Science

About the role

The Associate Director – TS/MS, will lead a technically comprehensive organization to provide oversight of biological and bioconjugate manufacturing processes in collaboration with engineering, IT, operations and quality functions. TS/MS is responsible for ensuring manufacturing processes run reliably in a state control through process monitoring supported through technical knowledge.

Responsibilities

• 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
• Provide coaching, mentorship and performance management to direct reports, ensuring individuals are developed to their full potential and the team is structured for long-term success
• 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

Required Education

BS, MS, or PhD in biology, biochemistry, chemistry, chemical engineering, or a related scientific discipline

Position Type

Full time

Basic Requirements

• Minimum of 10+ years of experience in the biopharmaceutical industry, with at least 5 years in a people leadership role

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