Executive Director / Sr Director, Supply Chain

Location
San Diego, CA, United States
Posted
Sep 19, 2020
Ref
391WW
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
Fate Therapeutics is seeking highly motivated supply chain management professional with broad materials management, inventory management and contract logistics expertise to help build and grow our supply chain function. This role will manage global supplies to ensure timely availability and optimum inventory of raw materials for clinical and future commercial manufacturing. Successful candidate will be responsible for planning, implementing and building our overall supply chain team in order to maximize efficiency and productivity. Fate's development programs involve novel cell therapeutic products which present unique product manufacturing and quality opportunities. Cell therapy manufacturing knowledge and familiarity with the pertinent regulations and how they apply to this field is desired. This is a full-time position currently reporting to the SVP Technical Operations and is located at our corporate headquarters in San Diego, CA. The Roles and

Responsibilities
include, but are not limited to, the following:

Responsibilities
• Oversee all operations for the supply chain management function.
• Coordinate and oversee execution of the supply chain from strategy to
commercialization.
• Lead short and medium-term capacity planning analysis to identify capacity expansion
requirements to support strategic objectives
• Oversee new cGMP Warehouse set up and operations.
• Lead the development of supply strategies and planning for consistent materials
availability for all clinical and future commercial manufacturing, and ensure enough supply to support uninterrupted manufacturing, including adequate planning for long lead time items, custom supplies and short expiry items.
• Lead the development of supply strategies for global clinical supplies.
• Identify any critical supply issues, develop and execute risk mitigation plans.
• Develop and maintain positive working relationships with key suppliers globally and
address technical issues impacting quality, delivery, or manufacturability of products.
• Responsible for facilitating the development, maintenance, and adherence to Supply
Agreements of critical raw materials.
• Act as the Tech Ops SME supporting QA during audits of critical raw material suppliers
and regulatory audits at Fate.
• Serve as key member of the Material Review Board and key contact for supplier change
notifications.
• Develop KPIs for internal functions and suppliers.
• Support CMC activities for IND filings.
• Act as source of knowledge in areas of supply chain best practices and methodologies;
Integrate supply chain best practices with business processes to enhance supply chain efficiencies.
• Heavy interface with Manufacturing, Development, and Quality and to develop and improve materials management and planning.
• Lead the design and development of cGMP supply chain management associated processes and procedures, including development of electronic systems.
• Ensure Standard Operating Procedures are current and effective across materials operations.
• Lead the effort to identify second vendors and alternative vendors for manufacturing materials and facilitate material qualification activities and mitigate supply risk with Development and Quality.
• Keep abreast of any changes in regulatory requirements that may impact the supply chain efforts and distribution.
• Train and evaluate Supply Chain team members.

Qualifications
• Bachelor's Degree and minimum 10-12 years related experience in a regulated supply chain environment, preferably in global commercial stage biotech or pharma
• Experience with commercial and clinical supply forecasting and budgeting
• Understanding of drug product CMC activities
• Experience working in a cGMP/GTP environment required
• A track record of success in meeting the production needs of a diverse internal and external customer base and ensuring uninterrupted flow of product and materials through manufacturing departments
• Strong leadership and an innate ability to collaborate and build relationships is critical
• The ability to develop and motivate teams and build a great culture throughout the organization. An inspirational leader with dedication towards team and people development
• Extensive knowledge with materials management software implementation and maintenance a plus
• Demonstrated ability to work cross-functionally with process development, quality, regulatory, and manufacturing groups
• Be proactive, resourceful, and detail-oriented to successfully contribute to Fate's rapidly growing, changing, and complex environment
• Able to prioritize and drive results with a high emphasis on quality
• Excellent interpersonal and communication skills

Working Conditions and Physical Requirements
• 80% on-site work at corporate headquarters in San Diego, CA
• 20% travel may be required The preceding job description indicates the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required from time to time. For consideration send cover letter and curriculum vitae to: careers@fatetherapeutics.com and reference job 391WW

About Fate Therapeutics, Inc.
Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for cancer and immune disorders. The Company has established a leadership position in the clinical development and manufacture of universal, off-the-shelf cell products using its proprietary induced pluripotent stem cell (iPSC) product

platform. The Company's immuno-oncology product candidates include natural killer (NK) cell and T-cell cancer immunotherapies, which are designed to synergize with well-established cancer therapies, including immune checkpoint inhibitors and monoclonal antibodies, and to target tumor-associated antigens with chimeric antigen receptors (CARs). The Company's immuno-regulatory product candidates include ProTmune™, a pharmacologically modulated, donor cell graft that is currently being evaluated in a Phase 2 clinical trial for the prevention of graft-versus-host disease, and a myeloid-derived suppressor cell immunotherapy for promoting immune tolerance in patients with immune disorders. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.