Senior Manager, Outsourced Manufacturing

Employer
Kite Pharma
Location
Santa Monica, CA, United States
Posted
Sep 12, 2019
Ref
R0009905
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
The Sr. Manager, Outsourced Manufacturing will play a critical role within the Kite Pharma manufacturing organization. Based in Santa Monica, CA the position will be responsible for overseeing all activities for clinical and/or commercial external manufacturing operations, driving multiple projects forward and assuring critical material supply. This position will be responsible for the management of one or more Contract Development Manufacturing Organizations (CDMO) with current focus of viral vector operations and potential for future modalities. The position will also have tactical responsibility for authoring and implementing scalable business processes for the external manufacturing team with guidance from the existing external manufacturing team members.

The Sr. Manager will have opportunities to work with and share knowledge with colleagues across Kite Pharma (e.g. Process Development and MSAT, Regulatory, Quality, Supply Chain, etc.), as well as multiple CDMO and Contract Test Lab organizations. Strong technical skills (biologics/viral vector operations, GMP regulation and drug development life cycle) and business skills (contract negotiation, project management and financial analysis) will be called upon in this position.

Roles And Responsibilities

The Sr. Manager, External Manufacturing will be responsible for:

• Managing one or more external contract manufacturing organizations for viral vector clinical and commercial products.

• Effectively managing critical issues, investigation and changes associated with critical material manufacture carried out by CDMO.

• Responsible for leading a cross-functional matrix team with objective for assuring CDMO manufactured critical material supply.

• Responsible for development and implementation of scalable business processes for the external manufacturing team that can be applied to critical materials throughout the product development lifecycle.

• Responsible for cross-training with existing external manufacturing team members to be able to step in when needed.

• Responsible for supporting technology transfer to CDMOs as required.

• Responsible for contract development and management for project based scopes of work in conjunction with CDMO business development and Kite Pharma Sourcing and Procurement teams.

• Supporting CMC regulatory submissions and inquiries for cell therapy portfolio related to CDMO and/or critical material manufacture, as required by the Product Operations team.

• Defining and implementing LEAN / Continuous Improvement / Operational Excellence initiatives.

REQUIREMENTS

• BS in engineering or a related scientific discipline. Advanced degree a plus

• 10+ years of Pharmaceutical or Biotechnology industry experience with gene/cell therapy experience and/or biologics manufacturing experience preferred.

• Strong manufacturing and engineering experience preferred in the areas of batch processing.

• Experience managing relationships with external contract manufacturers (CDMO's).

• Experience in technology transfer for development and commercial products and processes.

• Solid Knowledge of current Good Manufacturing Practices (GMPs).

• Understanding of deviation investigations, CAPA and Change Management a must.

• Experience contributing to biologics CMC regulatory submissions.

• Excellent oral and written communication skills.

• Strong interpersonal skills, a collaborator/ team player, open minded to the diverse opinions of others, able to manage effectively through influence.

• Ability to produce highest quality and timely work product/ documents with limited direction.

• A superior work ethic and a strong personal desire for success.

• Exceptional decision making skills in a challenging environment are a must.

• Up to 25% travel required

EXPERIENCE AND SKILLS

• Advanced skills in Quality Management Systems, broad understanding of laboratory, production, material, equipment and facility/utility operations.

• Advanced skills in Excel and PowerPoint.

• Advanced skills in Risk Assessments, FMEA and QbD

• Advanced skills with LEAN / Continuous Improvement / Operational Excellence tools

• Budget and Financial Planning experience.

#LI-HH1

Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.

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