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

Cyprotex•Redmond, WA

1d•$190,000 - $225,000•Onsite

About The Position

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. This position requires significant on-the-floor presence and leadership, focused specifically on day-to-day operations using disposable-based manufacturing technologies and ensuring cGMP compliance. Additional job responsibilities may include troubleshooting and/or providing technical expertise, finite scheduling, ensuring staff training compliance, executing against approved written procedures, participating in commissioning and validation activities, maintaining required cGMP compliant systems, and providing support for regulatory and site inspections.

Requirements

Bachelor’s degree in biological or engineering science
15+ years relevant experience
Technical mastery of cell culture, purification, and solution preparation operations using disposable-based manufacturing technologies
Proven knowledge of cGMP requirements to ensure compliance
Previous experience managing the activities of both individuals and large groups of staff
In-depth knowledge of equipment, operations, and engineering principles
Strong focus on quality and attention to detail
Effective task/time management organizational skills
Motivated, self-starter with strong mechanical aptitude
Good interpersonal, team, and communication skills
Excellent oral and written communication skills

Nice To Haves

Strong understanding of process automation (e.g. DeltaV) and BAS systems
Commissioning and validation experience, including risk assessments, user requirement specifications, execution of DQ, IQ, OQ, and PQ activities, and validation summary reports
Applies knowledge and expertise to solve complex technical problems
Significant contributor to multi-disciplinary teams at the functional level
Mentors and provides technical advice to individuals within the team
Thorough working knowledge of US FDA CFRs and European EMA, including ICH regulations.

Responsibilities

Lead a group of manufacturing staff in the execution of late-stage clinical and commercial biologics manufacturing operations.
Oversee cell culture, purification, and media/solutions preparation.
Provide on-the-floor presence and leadership for day-to-day operations.
Ensure cGMP compliance.
Troubleshoot and provide technical expertise.
Manage finite scheduling.
Ensure staff training compliance.
Execute against approved written procedures.
Participate in commissioning and validation activities.
Maintain required cGMP compliant systems.
Provide support for regulatory and site inspections.