Associate Director, Engineering

What you'll do

• Develop robust manufacturing processes for large molecule products and antigens.
• Execute "right-first-time" technology transfers of projects from R&D to production facilities.
• Manage a high-performing team by providing coaching, performance feedback, and career development.
• Drive data-driven decision making and risk mitigation strategies using methodologies like FMEA.
• Implement continuous process improvements to enhance manufacturing robustness and reduce cost of goods.
• Oversee technical stage-gate reviews and manage the execution of lab experiments to mitigate risks.
• Manage strategic initiatives and align internal goals with regional technology objectives.

What we're looking for

• Bachelor of Science in Chemical Engineering, Biotechnology, Biochemistry, Protein Chemistry, Biology, or a related field.
• Experience with a Bachelor's, with a Master's, or with a Doctorate.
• Direct management experience.
• Experience in technology transfer, process development, technical operations, or manufacturing in a regulated biopharmaceutical environment.
• Strong working knowledge of EMA, FDA, and/or USDA regulations and guidelines.
• Demonstrated ability to lead projects and manage priorities within a complex, fast-paced matrix organization.
• Experience with commercial biomanufacturing (sterile/aseptic, bulk drug substance, filling, lyophilization) in a regulated environment (preferred).
• Knowledge of statistical process control, design of experiments, or CMC regulatory processes (preferred).