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

Evotec WD; Redmond (WA); On-site; USD 190,000 - 225,000; Full time

Benefits offered by this job

Base pay range $190,000 – $225,000 at开

Discretionary annual bonus

Medical, dental, vision benefits

401(k) company match

Flexible work and generous PTO

Job summary

Evotec (US) Inc. seeks a seasoned manufacturing leader to supervise a group responsible for late-stage biologics operations, including cell culture, purification, and media/solutions preparation.

The role emphasizes hands-on leadership on the floor, adherence to cGMP, and execution against approved procedures. You will mentor staff, ensure training compliance, support commissioning and validation activities, and contribute to regulatory readiness and site inspections with a focus on quality and

Qualifications

• 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

Responsibilities

• Lead a group of manufacturing staff on day-to-day biologics operations
• Ensure on-floor presence and leadership with disposable-based manufacturing technologies
• Troubleshooting and providing technical expertise
• Manage scheduling and staff training compliance
• Execute against approved written procedures
• Participate in commissioning and validation activities
• Maintain cGMP-compliant systems and support regulatory site inspections

Education

Bachelor’s degree in biological or engineering science

Job description

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.

Education and 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

Preferred Qualifications

• 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

Benefits

• 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

Equal Opportunity Employer

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.