Senior Director, Head of Global Manufacturing Leads & Commercial Manufacturing Process Stewardship

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Job Description

Everyone at Kite is grounded by one common goal – curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Join us in our mission!

Kite is seeking a highly motivated individual to join us as Senior Director, Head of Global Manufacturing Leads and Commercial Manufacturing Process Stewardship (GML/CMPS) reporting to the Head of Global Manufacturing Sciences and Technology (MSAT). The Senior Director GML/CMS will lead an organization responsible for representing Manufacturing and MSAT on clinical and commercial CMC Teams (CMCTs) and lead in coordinating and prioritizing the commercial process life cycle management studies conducted in MSAT labs. You would lead an organization responsible for providing understanding of the manufacturing process/operations and ensuring all aspects of Manufacturing and MSAT are carefully considered cross-functionally as part of each product’s commercialization strategy. As this position collaborates with internal and external partners, thorough communication and leadership skills are needed.

Key responsibilities include (but not limited to):

· Support and manage a highly engaged world-class team providing strategic leadership that is aligned with the site, PD and with our global manufacturing network’s vision and mission.

· Oversee a team responsible for representing Manufacturing and MSAT on CMC Teams and collaborating cross-functionally with other CMC Team members.

· Lead in prioritizing and coordinating commercial product manufacturing process life-cycle management studies across the MSAT Lab network.

· Provide technical support for regulatory filings and in addressing health authority questions.

· Ensure alignment between Manufacturing Site Heads and the CMC Teams regarding manufacturing process life cycle priorities.

· Build a collaborative culture with key partners (site global) and customers including Manufacturing, Quality, Supply Chain, Network MSAT, Site MSAT Teams, Facilities Engineering, etc.

· Work with GMLs, CMCTs and stakeholders to develop short and long-term product strategies, product financial drivers, regional supply plans for products.

· Oversee or serve on cross functional teams and/or cross-site teams as needed.

Minimum Requirements

· PhD/MS degree in relevant Science or Engineering with at least 12+ years of biopharmaceutical manufacturing, technology transfer or process development experience. OR

· BA/BS degree in relevant Science or Engineering with at least 14+ years of biopharmaceutical manufacturing, technology transfer or process development experience.

Preferred Qualifications/Skills

· Demonstrated leadership experience in amplifying high performing teams and leading senior manufacturing and technical leaders.

· Excellent knowledge of GMP compliance, regulations and manufacturing operations

· Good understanding of tech transfer, Quality by Design, process validation and comparability.

· Experience in cell culture, aseptic processing, use of single use system and automation technologies is preferred.

· Knowledge of cell or gene therapy manufacturing is preferred.

· Excellent leadership skill (lead by influencing)

· Excellent prioritization, problem-solving and strategic planning skills

· Excellent 360-degree communication skills

· Knowledge of Six Sigma is a plus

Does this sound like you? If so, please apply today!