Manager, Manufacturing Operations - Site Based Redmond, WA

Manager, Manufacturing Operations - Support  | Redmond, WA

Just-Evotec is seeking a highly motivated Solution Prep and Manufacturing Operations Support Manager that desires a significant opportunity to improve worldwide access to biotherapeutics. The focus of this job is to guide the successful execution of clinical and commercial manufacturing operations while ensuring cGMP compliance. This position will be responsible for supervising 6-10 direct reports and overseeing Day Shift for a 24/7 operation.

The focus of this job is to manage the successful execution of clinical and commercial manufacturing operations while ensuring cGMP compliance. This position is responsible for managing a shift and requires significant on-the-floor presence, as well as technical subject matter expertise in operations.  Additionally, the manager oversees the GMP cleaning group. Job responsibilities include generation and maintenance of cGMP manufacturing and technical documentation, troubleshooting and/or providing technical expertise to perform troubleshooting efforts, ensuring staff safety, training and compliance, execution of plant start-up commissioning and validation activities, and implement and maintain required cGMP compliant systems.  May also participate in finite scheduling, aspects of technology and/or process transfer, identify process gaps and technology issues, determine solutions and remediation plans, provide support for regulatory and site inspections, and provide input to department capital and expense budgets. 

Shift Work Required- Dayshift: Wednesday-Saturday 4x10hrs- 06:45-17:30

Responsibility expectations:

• Provide key input in area of Manufacturing Operations expertise that impacts other individuals decisions within the company
• Use technical expertise to design/ implement new equipment, new disposable assemblies, or new molecule projects without guidance of prior protocols. 
• Provide technical guidance to others within the company.  - onboarding via current protocols
• Use technical depth and breadth to develop solutions to deviation investigations, leads CAPA projects, or coordinate more in depth troubleshooting issues where vendors may be involved.
• May lead cross-functional teams within and external to Just.  May be a core department lead in NPI. Responds to equipment alarms. "
• Significant contributions to controlled documents.
• Present and/or defend data within and external to our organization (audits).
• Communicates logical, organized and clearly
• Be a technical resource in multiple operational areas within functional group. 
• Have a deeper understanding of regulatory requirements. 
• Contribute/ lead implementation of new technology or technical improvements. 
• Attend conferences/forum
• Lead teams within area of expertise within or external to the company.
• Hire to fit established culture."
• Supervise unit operations within MFG.

Educational Requirements:

• Master’s degree and 4 years plus of Manufacturing or Operations experience; or
• Bachelor’s degree and 6 plus years of Manufacturing or Operations experience  

Qualification Requirements:

• Proven knowledge of cGMP requirements to ensure compliance
• Significant experience in operations required for the manufacture of biotherapeutics
• Proven record of accomplishment leading and developing staff
• Candidate must possess strong focus on quality and attention to detail
• Excellent communication with senior leadership
• Possess effective task/time management organizational skills
• Capacity to develop solutions to technical issues of moderate scope
• Ability to organize, analyze/interpret, and effectively communicate data and results
• Motivated, self-starter
• Excellent interpersonal, team, and communication skills
• Demonstrating emotional intelligence in decision-making, motivating teams, and fostering a positive workplace culture.

Additional Preferred Qualifications:

• In-depth knowledge of equipment, operations, and engineering principles
• Change control, NC/CAPA, and deviations
• Fundamental understanding and basic operation of process automation (DeltaV)
• Experienced in technology and/or process transfer for late stage clinical manufacturing or commercial qualification campaigns; commercial campaign support
• Active participation/lead technical projects with collaborators and vendors
• Experience with finite scheduling tools and allocation of resources and equipment

The base pay range for this position at commencement of employment is expected to be $91,560 to $125,350;  Base salary offered may vary depending on 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.