Director - Manufacturing Operations

Just is seeking a highly motivated Director, Manufacturing Operations, that desires a significant opportunity to improve worldwide access to biotherapeutics. The focus of this job is to lead a group of manufacturing staff in the execution of late-stage clinical and commercial biologics manufacturing operations, including cell culture, purification, and media/solutions preparation. This position requires significant on-the-floor presence and leadership, focused specifically on day-to-day operations using disposable-based manufacturing technologies and ensuring cGMP compliance. Additional job responsibilities may include troubleshooting and/or providing technical expertise, finite scheduling, ensuring staff training compliance, executing against approved written procedures, participating in commissioning and validation activities, maintaining required cGMP compliant systems, and providing support for regulatory and site inspections.

Educational Requirements:

• Bachelor's degree in biological or engineering science with 15+ years relevant experience

Qualification Requirements:

• Technical mastery of cell culture, purification, and solution preparation operations using disposable-based manufacturing technologies
• Proven knowledge of cGMP requirements to ensure compliance
• Previous experience managing the activities of both individuals and large groups of staff
• In-depth knowledge of equipment, operations, and engineering principles
• Candidate must possess strong focus on quality and attention to detail
• Possess effective task/time management organizational skills
• 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:

• Strong understanding of process automation (e.g. DeltaV) and BAS systems
• Commissioning and validation experience, including risk assessments, user requirement specifications, execution of DQ, IQ, OQ, and PQ activities, and validation summary reports
• Applies knowledge and expertise to solve complex technical problems
• Significant contributor to multi-disciplinary teams at the functional level
• Mentors and provides technical advice to individuals within the team
• Thorough working knowledge of US FDA CFRs and European EMA, including ICH regulations

About Just

Just is an integrated design company focused on the technology of biotherapeutics from molecule through manufacturing plant. We believe that technological innovation will accelerate development and dramatically reduce the cost of these vital medicines. The Just mission: design and apply innovative technologies to dramatically expand global access to biotherapeutics. Come join our team of experts to help shape a better future.