Manufacturing Manager - Nights, Site Based, Redmond, WA

About the role

This position is responsible for supervising a shift to cover 24/7 operation, requiring significant on-the-floor presence and technical subject matter expertise in purification operations. The manager will generate and maintain cGMP manufacturing and technical documentation, troubleshoot or provide technical expertise for investigations, ensure staff training and compliance, execute plant start-up commissioning and validation activities, and implement and maintain required cGMP-compliant systems.

The role may also involve finite scheduling, technology and/or process transfer, identifying process gaps and technology issues, determining solutions and remediation plans, supporting regulatory and site inspections, and providing input to department capital and expense budgets.

Responsibilities

• Supervise a shift in a 24/7 manufacturing operation with a strong on-the-floor presence.
• Generate and maintain cGMP manufacturing and technical documentation.
• Troubleshoot and provide technical expertise for investigations or lead troubleshooting efforts.
• Ensure staff training and compliance with cGMP requirements.
• Execute plant start-up commissioning and validation activities.
• Implement and maintain cGMP-compliant systems.
• Participate in finite scheduling and aspects of technology/process transfer.
• Identify process gaps and technology issues, and determine solutions and remediation plans.
• Support regulatory and site inspections.
• Provide input to department capital and expense budgets.
• Lead cross-functional teams within and external to the organization.
• Respond to equipment alarms.
• Execute downstream technology strategies, including bioreactor recovery, chromatography column purification, impurity removal, viral inactivation and filtration, UF/DF, and sterile filtration.

Requirements

• Master’s degree and 3 years of Manufacturing or Operations experience; or Bachelor’s degree and 5 years of Manufacturing or Operations experience.
• Knowledge of cGMP requirements to ensure compliance.
• Significant experience in purification operations for the manufacture of biotherapeutics.
• Strong focus on quality and attention to detail.
• Excellent communication skills with senior leadership.
• Effective task/time management and organizational skills.
• Ability to develop solutions to technical issues of moderate scope.
• Capacity to organize, analyze/interpret, and effectively communicate data and results.
• Motivated, self-starter with strong mechanical aptitude.
• Good interpersonal, team, and communication skills.

Preferred Qualifications

• Proven record of accomplishment managing, supervising, and developing staff.
• In-depth knowledge of purification equipment, operations, and engineering principles.
• Recognized technical mastery of disposable manufacturing technologies at commercial scale.
• Experience participating in client and regulatory agency audits.
• Technical depth and breadth to develop solutions for deviation investigations, lead CAPA projects, or coordinate troubleshooting involving vendors.
• Fundamental understanding and basic operation of process automation (DeltaV).
• Experience in technology and/or process transfer for late-stage clinical manufacturing or commercial qualification campaigns, including commercial campaign support.
• Ability to apply knowledge and expertise to solve complex technical problems, potentially using novel approaches for significant technology advancement.
• Active participation or leadership in technical projects with collaborators and vendors.
• Experience with finite scheduling tools and allocation of resources and equipment.

Pay

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.

Benefits

• Discretionary annual bonus.
• Comprehensive benefits, including Medical, Dental, and Vision.
• Short-term and long-term disability.
• Company-paid basic life insurance.
• 401k company match.
• Flexible work arrangements.
• Generous paid time off and paid holidays.
• Wellness and transportation benefits.