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

Evotec SE

Union Hill-Novelty Hill (WA)

Sur place

USD 190 000 - 225 000

Plein temps

Il y a 11 jours

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Avantages offerts par ce poste

Growth opportunities
Flexible work environment
Inclusive culture
Innovative projects
Big ideas culture

Résumé du poste

Evotec (US) Inc. seeks a senior manufacturing leader to direct a team in late-stage biologics production, including cell culture, purification, and solution prep.

The role requires on-floor leadership, significant hands-on oversight of day-to-day operations with disposable-based technology, and strict adherence to cGMP. Candidate must have a biology/engineering background with extensive experience, strong leadership, and proven ability to manage large staff groups while ensuring quality and

Qualifications

  • Bachelor’s degree in biological or engineering science with 15+ years of related experience.
  • Technical mastery of cell culture, purification, and solution preparation operations using disposable-based manufacturing technologies.
  • Proven knowledge of cGMP requirements to ensure compliance.
  • Experience managing activities of individuals and large groups of staff.
  • Strong knowledge of equipment, operations, and engineering principles.
  • Excellent attention to quality and detail; strong task/time management.
  • Motivated self-starter with strong mechanical aptitude and communication skills.

Responsabilités

  • Lead a group of manufacturing staff in late-stage biological manufacturing operations on the floor.
  • Oversee day-to-day operations using disposable-based technologies and ensure cGMP compliance.
  • Troubleshoot issues, provide technical expertise, and support scheduling and training.
  • Execute against written procedures, participate in commissioning and validation activities.
  • Maintain cGMP compliant systems and provide support for regulatory inspections.

Connaissances

Leadership
Cell culture
Purification
Solution preparation
cGMP compliance
Staff management
Equipment knowledge
Communication skills
Quality focus

Formation

Bachelor’s degree in biological or engineering science
15+ years relevant experience

Outils

DeltaV
BAS systems

Description du poste

About Us: this is who we are

At Evotec, we believe that curiosity is the spark that drives innovation and success. As a forward-thinking team, we thrive on challenging the status quo, learning from each other, and pushing the boundaries of what’s possible. We're on a mission to create a place where curiosity isn't just encouraged—it’s celebrated.

Are you someone who asks questions, seeks answers, and isn't afraid to go deeper? #BeCureious with us and see where your curiosity can take you!

The Role: / your challenge, …in our journey

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.

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
  • Candidate must possess strong focus on quality and attention to detail
  • Possess effective task/time management organizational skills
  • Motivated, self-starter with strong mechanical aptitude
  • Good interpersonal, team, and communication skills are a must
  • Excellent oral and written communication skills
Additional 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 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.
Why Join Us:
  • Growth Opportunities: We’re a company that believes in continuous learning and development. Whether it’s professional courses, mentorship, or new projects, we’ll help you grow.
  • Flexible Work Environment: We offer flexible work options to help you balance your professional and personal life. This is a site based role.
  • Inclusive Culture: We’re committed to building a diverse and inclusive environment where everyone’s voice is valued, and curiosity is encouraged.
  • Innovative Projects: You’ll have the chance to work on groundbreaking initiatives and cutting-edge technology in an atmosphere where your curiosity is the key to success.
  • A Place for Big Ideas: We don’t just talk about thinking outside the box—we throw the box away. If you’ve got ideas, we want to hear them.
Are You Still Curious?

Let your curiosity guide your career—#BeCurious and explore the endless possibilities at Evotec!

The base pay range for this exempt, salaried position at commencement of employment is expected to be $190,000 to $225,000. Base salary offered may vary depending on the individual’s skills, experience and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, short-term and long-term disability, company paid basic life insurance, 401k company match, flexible work, generous paid time off and 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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