Sr. Manager, Manufacturing -  J.POD Cell Culture

Just is seeking a highly motivated cell culture manufacturing senior 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 and overseeing multiple shifts 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 senior 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 6 years of Manufacturing or Operations experience; or
• Bachelor's degree and 8 years of Manufacturing or Operations experience

Qualification Requirements:

• Proven knowledge of cGMP requirements to ensure compliance
• Significant experience in cell culture operations required for the manufacture of biotherapeutics
• Proven record of accomplishment managing, supervising and developing staff
• Candidate must possess strong focus on quality and attention to detail
• 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
• Excellent oral and written communication skills

Additional Preferred Qualifications:

• 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
• Experience with finite scheduling tools and allocation of resources and equipment
• 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 is a plus
• Applies knowledge and expertise to solve complex technical problems; may apply novel approach that provides significant technology advancement
• Significant contributor to multi-disciplinary teams at the functional level; mentors and provides technical advice to individuals within the team
• Active participation/lead technical projects with collaborators and vendors

About Just - Evotec Biologics

Just - Evotec Biologics, wholly-owned by Evotec SE, is a unique platform company that integrates the design, engineering, development, and manufacture of biologics. With deep experience in the fields of protein, process and manufacturing sciences, the Just team came together to solve the scientific and technical hurdles that block access to life-changing protein therapeutics; from the design of therapeutic molecules to the design of the manufacturing plants used to produce them. Just's focus is to create access and value for a global market through scientific and technological innovation. Our state-of-the-art labs and cGMP clinical manufacturing plant are co-located in Seattle's South Lake Union neighborhood - the center of Seattle's medical, global health, and technology industries and a noted top emerging life science hub in the U.S. Our fast-growing team of 100 employees is expanding Just's innovative platform and footprint - building our first North American J.POD® commercial manufacturing facility in the Seattle area. For job opportunities, learn more at www.just.bio/careers