Senior Director, Manufacturing Operations - Site , Redmond, WA
Listed on 2026-07-24
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Quality Assurance - QA/QC
Regulatory Compliance Specialist
Role
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 responsibilities 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.
Educationand Qualification 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 and organizational skills
- Motivated, self‑starter with strong mechanical aptitude
- Excellent interpersonal, team, and communication skills – both oral and written
- 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 multidisciplinary 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
- Base pay range for this exempt, salaried position: $190,000 – $225,000 at commencement of employment
- Discretionary annual bonus
- Comprehensive benefits including medical, dental, vision, short‑term and long‑term disability, company‑paid basic life insurance, 401(k) company match
- Flexible work, generous paid time off, paid holiday, wellness and transportation benefits
Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.
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