Supply Chain Program Director

Location
Cambridge, MA; Seattle, WA; South San Francisco, CA
Posted
Jan 21, 2022
Ref
5787591002
Required Education
Bachelors Degree
Position Type
Full time

About the role

Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of engineered cells as medicines, who want to challenge status quo, and who lead with the desire to work on novel ideas.  As Supply Chain Program Lead/Director, you will report to VP, Head of Supply Chain to build the end-to-end supply chain that delivers engineered cells as medicines to our patients.  You will be an integral member of cross-functional teams, connecting CMC development with clinical development.  You will establish the tools and processes to control and manage a complex network of suppliers and manufacturing processes that begins with human donor cells and extends all the way to administration at the patient’s bedside. Cool stuff.

What you’ll do

  • Establish end to end supply strategy for one or more clinical stage cell or gene therapy development programs; translate strategy into an operational supply plan; drive execution against the plan including oversight of external vendors and partners. Responsible for end to end visibility throughout complex product journey to ensure seamless patient journey 
  • Collaborate with other members of Sana’s supply chain team to build out supply chain capability that matches our technologies, programs, and ambitions. Includes establishing the operating model, roles, tools, processes, and relationships needed for scalable and sustainable delivery of engineered cells to patients
  • Serve as the supply chain representative in cross-functional cell or gene therapy program teams, bridging between CMC, clinical, and regulatory disciplines. Responsible for recognizing program-level changes that impact the operational supply plan and proactively identifying adjustments, risks, options, and tradeoffs. Continually assess supply chain risk and recommend mitigation solutions to program teams and leadership
  • Develop program and study relevant forecasts and supply plans that incorporate expiry management and complex multi-country regulatory requirements
  • Collaborate with SMEs from clinical organization to define and implement study-appropriate site-facing logistics and dosing which may include just in time scheduling and distribution, and complex dose preparation and administration procedures
  • Establish and maintain traceability for engineered cells throughout product and patient journey
  • Responsible for a reliable integrated global supply chain for one or more clinical stage development including manufacturers for critical raw materials, Drug Substance, Drug Product, Label-Pack Finished Product and Distribution partners
  • Develop innovative solutions to the physical and technological challenges facing a cell and gene therapy supply chain
  • Create and update SOPs for the clinical supply chain function

What we’re looking for

  • Bachelor's degree in science, pharmacy, or related field
  • 10+ years of experience in pharmaceutical or life sciences industry with 3+ years in clinical supply chain
  • Experience establishing fit for purpose supply strategy that enables first in human studies
  • Experience scaling fit for purpose supply strategy for
  • Ability to develop forecasts and supply plans for clinical products
  • Track record of working and leading in matrix organization and influencing across multi-site, multi-function program teams
  • Experience managing and providing sponsor oversight work done by CRO or CMO vendors
  • Ability to operate effectively in a dynamic start-up environment that requires learning agility and the ability to plan and execute through ambiguity
  • Ability to communicate strategic and technical concepts, plans, and tradeoffs effectively to stakeholders at many levels of the organization and from different technical functions or backgrounds

What will separate you from the crowd

  • Cell Therapy clinical supply chain experience
  • Experience with ultra cold chain (cryo) logistics
  • CDMO, Vendor or relationship management experience
  • Experience in late stage or commercial supply chain management
  • Global logistics, import/export or customs brokerage
  • IRT medication management module strategy and requirements setup
  • APICS certification

What you should know

  • Working safely in person on a predictable and regular in-person basis is an essential job function for this position, and the Company requires that all individuals working in-person be fully vaccinated against COVID-19, including receipt of a vaccine booster shot if recommended by the CDC

How we work together

  • Lead from every seat – we seek to understand, act with honesty, and engage in the crucial conversations
  • Thrive as a team – we hire amazing people, are intensely curious, and cultivate inclusion and personal connectivity
  • Make it happen – we value vigorous debate, alignment around our decisions, and resilient execution

Get to know us

At Sana, we believe that a diverse workforce strengthens us as a company and helps us to achieve our mission to meaningfully change the outcome of many human diseases. This belief is a pillar of our business and is critical to our success. Our goal is that Sana is the place for talented people to bring their authentic selves to work, to have a great career and to deeply, positively impact patients.

Core to our values, we believe there is nothing more important than the health and wellness of you and your family. For benefit eligible employees, we cover 100% of the cost for employee health coverage and offer generous time-off, parental leave, short- and long-term disability, financial wellness programs, a 401(k) Plan, Employee Stock Purchase Plan, commuter subsidy and a variety of wellness offerings to support each person individually.

We are committed to providing a workplace free of discrimination and harassment based on race, color, religion, age, gender, national origin, ancestry, physical or mental or sensory disability (including the use of a trained guide dog or service animal by a person with a disability), genetic information, actual or perceived HIV or Hepatitis C infection, medical condition (cancer or a record or history of cancer and genetic characteristics), marital status, sexual orientation, sexual preference, pregnancy (including childbirth and related medical conditions), disability, veteran status, political ideology, taking or requesting statutorily protected leave, status as a victim of domestic violence, sexual assault or stalking, or any other basis prohibited by applicable law.

To perform this job successfully, you must be able to perform each job responsibility satisfactorily. The job description listed above is representative of the knowledge, skills, and/or abilities required for this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions described above.