Manufacturing Manager - Nights, Site Based, Redmond, WA

Just-Evotec Biologics•Redmond, WA

5d•Onsite

About The Position

This position will be 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 purification 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.

Requirements

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
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.
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
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