Associate Director, Viral Vector Downstream Manufacturing

Descripción del trabajo

Role and Responsibilities:

Kite Pharma a Gilead Sciences Company has an opportunity for an experienced Associate Director of Downstream Manufacturing Operations at our Oceanside biologics facility in Southern California. We are seeking motivated, team-oriented leaders with expertise in manufacturing of vector, large molecules, vaccines. Reporting to the Director of Manufacturing, you will have the opportunity to lead the purification and the fill finish and packaging manufacturing teams.

The Associate Director of Downstream Manufacturing will be responsible for coordination, oversight, and execution of GMP manufacturing activities related to buffer preparation, purification, fill finish and packaging. We are seeking motivated, team-oriented leader with expertise in building teams and optimization of operation units. The Associate Director may serve as a project lead or team representative on cross-functional projects. This position will be responsible for direct reports and be tasked with effective development of team capabilities.

Responsibilities include:

• Lead Kite Vector Downstream Manufacturing team that is responsible for safe, quality and efficient buffer prep, cell purification, and fill & finish/packaging of vector substance production
• Provide strategic and technical leadership, as well as training, coaching, staff development, and annual performance reviews
• Direct the activities of Downstream Manufacturing operations groups including Production and cGmP Cleaning as strong manufacturing partners
• Define, plan, and implement activities/projects related to campaign or production readiness, new product introduction (NPI), and product changeover operations to ensure production schedules are met
• Identify and implement process improvement opportunities and/or corrective actions to increase yield, maximize capacity, improve operational efficiency, reduce costs, and ensure safety while maintaining regulatory compliance
• Determine metrics for success and evaluate performance against metrics
• Partner with Vector Process Development, Quality, Validation, Engineering, Maintenance, BSO, MSAT, and Supply Chain (Warehouse/Materials Management/Planning) to ensure timelines, deliverables, and business operations are aligned and met
• Oversight of completion and closure of all deviations, CAPA's, incidents, and change managements within the Manufacturing department
• Lead or represent the department as a member of a cross-functional project team providing guidance, insight and recommendations relative to the goals and objectives of the Manufacturing operations’ function
• Identifies risks and creates working plans to prevent issues
• Leads supervisors to ensure safety and compliance are adhered to by team and drives culture of operational excellence
• Supports various governmental agencies/regulators and external and internal audits or inspections

This is an exempt (salary) position that will include weekend and off hours coverage.

Basic Requirements:

• A Ph.D. and 2+ years of experience in manufacturing in the pharmaceutical industry OR
• A MS/MA and 8+ years of experience in manufacturing in the pharmaceutical industry OR
• A BS/BA and 10+ years of experience in manufacturing in the pharmaceutical industry OR
• A High School Diploma and 14+ years of experience in manufacturing in the pharmaceutical industry

Preferred Requirements:

• 10 years bio manufacturing management experience in a Current Good Manufacturing Practices (cGMP) bioprocess environment
• Experience in cell banking and cell purification and fill/finish/packaging (bio-manufacturing)
• Demonstrated influencer cross-functionally with senior leaders
• Strong knowledge of quality systems, validation principles, regulatory guidelines, and multi-product controls
• Experience with Single-Use Technology scale manufacturing equipment and distributed control systems (DCS) such as DeltaV and automated process equipment
• Experience with Clinical (Phase II/III) and Commercial production
• Experience with Electronic Batch Records in manufacturing
• Background in disposable technology and multi-product facility desired
• Consistent positive attitude and demonstrated ability to learn new skills
• Strict adherence to established safety and compliance practices and standards
• Ability to think critically, with demonstrated troubleshooting and problem-solving skills as applicable to manufacturing process, documentation, and equipment
• Self-motivated and willing to accept temporary responsibilities outside of initial job description
• Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities
• Ablity to work off hours as well as weekends as needed