Mgr, Manufacturing Operations

Manager, Manufacturing – J.POD Upstream Purification | Just. – Redmond, WA |

Just is seeking a highly motivated cell culture manufacturing manager that desires a significant opportunity to improve worldwide access to biotherapeutics. The focus of this job is to guide the successful execution of upstream clinical and commercial manufacturing operations while ensuring cGMP compliance. This position will responsible for supervising a shift to cover 24/7 operation and requires significant on-the-floor presence, as well as technical subject matter expertise in cell culture operations. Additional job responsibilities will 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 training and compliance, execution of plant start-up commissioning and validation activities, 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.

Educational Requirements:

• Master’s degree and 3 years of Manufacturing or Operations experience; or
• Bachelor’s degree and 5 years of Manufacturing or Operations experience

Qualification Requirements:

• Knowledge of cGMP requirements to ensure compliance
• Significant experience in cell culture operations required for the manufacture of biotherapeutics
• 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 with strong mechanical aptitude
• Good interpersonal, team, and communication skills are a must
• May lead cross-functional teams within and external to Just. May be a core department lead in NPI.
• Responds to equipment alarms.
• Excellent oral and written communication skills

Additional Preferred Qualifications:

• Proven record of accomplishment managing, supervising and developing staff
• In-depth knowledge of cell culture equipment, operations, and engineering principles
• Recognized technical mastery of disposable manufacturing technologies at commercial scale
• Participation in client and regulatory agency audits
• Uses technical depth and breadth todevelop solutions to deviation investigations, leads CAPA projects, or coordinates more in depth troubleshooting issues where vendors may be involved.
• 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
• Application of knowledge and expertise to solve complex technical problems; may apply novel approach that provides significant technology advancement
• 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 $100,000 to $150,000; 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 and 401k company match, flexible paid time off and paid holiday, wellness and transportation benefits.

FR : Dans le cadre de sa politique Diversité, Evotec étudie, à compétences égales, toutes les candidatures dont celles des personnes en situation de handicap.

ENG : In the frame of our Diversity policy, Evotec considers, with equal competences, all applications including people with disabilities.