Manufacturing Manager - Nights, Site Based, Redmond, WA

Cyprotex•Redmond, WA

23h•Onsite

About The Position

At Just Evotec Biologics, 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. We’re looking for a passionate and curious Manager, Manufacturing Operations to join our team. If you’re excited by new challenges, solving complex problems, and learning every step of the way, you might just be the perfect fit. In this role, you’ll have the opportunity to drive impactful projects, collaborate with bright minds, and explore uncharted territories. As Manager, Manufacturing Operations at Just Evotec Biologics, you'll have the freedom to ask the hard questions, think outside the box, and find creative solutions that push us forward. It’s a role where your curiosity will fuel both your personal growth and the success of the team.

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 required for the manufacture of biotherapeutics
Strong focus on quality and attention to detail
Execute downstream technology strategies from bioreactor recovery, chromatography column purification, impurity removal, viral inactivation and filtration, UF/DF, and sterile filtration
Excellent communication with senior leadership
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.
Excellent oral and written communication skills

Nice To Haves

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
Participation in client and regulatory agency audits
Uses technical depth and breadth to develop 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

Responsibilities

Supervising a shift to cover 24/7 operation and requires significant on-the-floor presence, as well as technical subject matter expertise in purification operations.
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.
Implement and maintain required cGMP compliant systems.
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.
Provide input to department capital and expense budgets.
Responds to equipment alarms.