Manager, Manufacturing - Purification - Site Based Seattle, WA

Manager, Manufacturing Operations Purification

The focus of this job is to guide the successful execution of clinical and commercial manufacturing operations while ensuring cGMP compliance. This position is responsible for supervising and overseeing Day/Swing/Night shifts and to cover 24/7 operation and requires significant on-the-floor presence, as well as technical subject matter expertise in Solution Prep, Facility Cleaning and other GMP support operations.  Additional job responsibilities include generation and maintenance of cGMP manufacturing and technical documentation, troubleshooting and/or providing technical expertise to perform troubleshooting efforts or lead investigations, ensuring staff safety, training and compliance and implement and maintain required cGMP compliant systems.  The manager 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.

*Note : Manufacturing operations in Jplant Seattle occur 7 days a week, day shifts only and extended shifts as required based on process requirements. 40 hours, days only. shifts could be; Monday to Friday, Tuesday to Saturday or Sunday to Thursday. between 8:00 am till 5:00 pm.

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, lead 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.  Respond to equipment alarms.   
• Significantly contribute to controlled documents. Present and/or defend data within and external to our organization (audits).
• Communicates logical, organized and clearly written. 
• Is a technical resource in multiple operational areas within functional group with a deeper understanding of regulatory requirements.
• Contribute/ lead the implementation of new technology or technical improvements. 
• Attend conferences/forum
• Lead a teams within area of expertise within or external to the company.
• Supervise unit operations within MFG.

Basic Qualifications :

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

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
• Demonstrating emotional intelligence in decision-making, motivating teams, and fostering a positive workplace culture

This job description is intended to describe the general content of the job, and to identify the essential functions of and requirements for the performance of this job.  It is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Because job requirements evolve with the changing needs of Just-Evotec Biologics business, this description is subject to change and may be modified at any time, whether formally or informally.

The base pay range for this position at commencement of employment is expected to be $91,560 to $126,500;  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.