Senior Director, Manufacturing Operations - Site Based, Redmond, WA

The focus of this job is to lead a group of manufacturing staff in the execution of late-stage clinical and commercial biologics manufacturing operations, including cell culture, purification, and media/solutions preparation. Requires significant on-the-floor presence and leadership for day-to-day operations using disposable-based manufacturing technologies and ensuring cGMP compliance. Additional responsibilities may include troubleshooting and/or providing technical expertise, finite scheduling, ensuring staff training compliance, executing approved written procedures, participating in commissioning and validation activities, maintaining required cGMP-compliant systems, and supporting regulatory and site inspections.

Qualifications / Requirements:
- Bachelor’s degree in biological or engineering science; 15+ years relevant experience
- Technical mastery of cell culture, purification, and solution preparation using disposable-based manufacturing technologies
- Proven knowledge of cGMP requirements; experience managing both individuals and large groups
- In-depth knowledge of equipment, operations, and engineering principles
- Strong focus on quality and attention to detail; effective task/time management; motivated self-starter with strong mechanical aptitude
- Strong interpersonal, team, and communication skills; excellent oral and written communication

Preferred Qualifications:
- Process automation (e.g., DeltaV) and BAS systems
- Commissioning/validation experience (risk assessments, URS, DQ/IQ/OQ/PQ, validation summary reports)
- Ability to solve complex technical problems; contribute to multi-disciplinary teams; mentors/technical advisor
- Working knowledge of US FDA CFRs, European EMA, including ICH regulations

Application instructions: Apply today.