The Associate Director, Engineering will lead the end-to-end operational strategy, execution, and performance of the FLEx Sterile facility, shaping the operational culture from the ground up
Job Summary
The Associate Director, Engineering will lead the end-to-end operational strategy, execution, and performance of the FLEx Sterile facility, shaping the operational culture from the ground up.
Key responsibilities include building and leading the Operations organization, partnering with engineering and quality for C&Q alignment, and establishing GMP-compliant operating procedures.
Success will be measured by the facility's transition to cGMP operations on schedule, a high-performing and compliant operations team, and timely delivery of clinical batches with robust quality outcomes.
Matching Summary
The Associate Director, Engineering will lead the end-to-end operational strategy, execution, and performance of the FLEx Sterile facility, shaping the operational culture from the ground up.
Salary
$142,400.00 - $224,100.00; Bonus/Equity: Eligible for annual bonus and long-term incentive; Benefits: Comprehensive package including medical, dental, vision, 401(k), paid holidays, vacation, and sick days
Skills & Requirements
Must-have
aseptic drug product manufacturing
aseptic filling lines
isolators and lyophilizers
cGMP and aseptic processing
operational excellence methodologies
daily management systems
Nice-to-have
patient-centric environment
continuous learning culture
right-first-time execution
data-driven decision-making
empowerment and accountability
Key Requirements
Bachelor's degree or higher with 4-8 years of relevant experience
Proven leadership in aseptic drug product manufacturing
Hands-on experience with C&Q and facility start-up