
Senior Manager of Supply Chain - Contract Development and Manufacturing Operations (CDMO)
美国 - 加利福尼亚州 - 圣莫尼卡制造运营和供应链正式员工职位描述
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. Would you like to join us in this mission?
We are seeking a highly motivated individual to join us as a Senior Manager to support Kite’s goals in securing external supply from contract development and manufacturing organizations (CMOs/CDMOs). This opportunity will closely collaborate with both external manufacturing partners and internal teams as well as report to the Associate Director – External Supply Partnerships at Kite.
The Senior Manager will play a critical role within our external manufacturing team and will be passionate about managing external manufacturing partners and supporting internal, cross-functional collaboration. As such, the Incumbent will be responsible for supporting day to day activities, planning, direction, and oversight of end-to-end programmatic requirements as it relates to CMO/CDMO activities, as well as recommending and implementing process optimizations.
Key responsibilities include close collaboration with external manufacturing partners to develop and maintain relationship alongside the current external manufacturing team, and leading internal focus factory teams to ensure external supply targets are met and operational activities are completed. The Senior Manager will have opportunities to work with and share knowledge with leaders and partners across Kite’s Technical Operations organization (e.g. Process Development and MSAT, Regulatory, Quality, Finance, Manufacturing, and Supply Chain), and collaborate cross functionally to identify, escalate, and propose mitigation plans for project related risks and develop project related dashboards and regular status updates. The Senior Manager will also be responsible for day-to-day activities including but not limited to contractual review and support, document review and approval, batch documentation review, planning and oversight of supply related activities, implementation of metric planning, ongoing evaluation of existing and potential CDMOs and development of value propositions, and creation of ad hoc reports and presentations as necessary.
The ideal candidate will have excellent communication skills and problem-solving abilities and will have technical background while being committed to collaboration and continuous improvement. Experience with data analysis is also preferred.
To create a deep partnership with stakeholders and leaders across the corporation, as well as to foster continued professional growth, we would like the Senior Manager to be based onsite 3 days a week at Kite's Global HQ in Santa Monica, CA (and will provide a comprehensive relocation package as needed). Additionally, the Incumbent should expect domestic and international business travel 30% to 40% of the time.
Responsibilities of the Senior Manager of Supply Chain - Contract Development and Manufacturing Operations (CDMO):
Assists on development of risk mitigation planning and implementation
Supports development and maintenance of CDMO performance metrics and reporting
Material planning and ordering to ensure no disruption to patient supply
Collaborates with External Quality Operations and Product Quality Leads on disposition planning
Collaborates with key business stake holders to ensure URSs, Specifications, Part Numbers and other business enabling documents are created to support work with CMOs
Supports the current CDMO team in routine communications with CDMOs and internal stakeholders
Owns Change Controls and deviation investigations as needed for clinical and commercial materials
Provides strong understanding of GMP operations and Quality systems required to maintain a GMP environment
Collaborates with Operations Teams and Regulatory to ensure program timelines are met and regulatory preparation has been aligned with the CDMO
Supports Sourcing and Procurement in sourcing events, RFPs, and contract development
Supports contract review and negotiation and development Scope of Work proposals
Evaluates current and potential CDMOs and associated make versus buy evaluation
Maintains updated CDMO data
Leads and participates in continuous improvement initiatives at the CDMOs and within the internal Kite network
Basic Qualifications:
PhD
OR
MA / MS with 6+ years of Supply Chain and/or Operations and/or External Manufacturing experience
OR
BA / BS Degree with 8+ years of Supply Chain and/or Operations and/or External Manufacturing Experience
OR
Associate Degree with 10+ years of Supply Chain and/or Operations and/or External Manufacturing Experience
OR
High School Diploma / GED and 12+ years of Supply Chain and/or Operations and/or External Manufacturing experience
Preferred Qualifications:
5+ years of experience working in External Manufacturing
5+ years of experience working in the biotechnology and/or pharmaceutical industry
2+ years working in cell therapy manufacturing
Experience with optimization and statistical data analysis resources
Knowledge of sourcing, contract negotiations, and supplier oversight
Ability to analyze, summarize, and present insights based on the needs of the audience
Exceptional understanding and application of Procurement principles, concepts, practices, and standards (i.e. effective negotiation, supplier relationship management, business partnering, supplier diversity etc.) along with an in-depth knowledge of industry practices
Ability to develop business cases and champion opportunities with quantifiable financial benefits
Demonstrated experience in identifying and utilizing full set of levers to drive value for customers
Ability to conduct benchmarking to address cost, quality, risk and innovation considerations
Demonstrated experience with internal stakeholder management, data/information management, category management, process redesign and continuous improvement expertise, project management and performance measurement skills
Familiar with smartsheet and data analytics platforms
Ability to establish credibility and influence diverse audiences so as to be perceived as a lead
Strong project management and organizational skills
Does this sound like you? If so, please apply today!
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