Clinical Supply Chain Manager

Cambridge, MA; South San Francisco, CA
Feb 05, 2024
7119093002
Bachelors Degree
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 a senior manager of clinical supply, you will report to the Supply Chain Program Director working to ensure that every patient enrolled in a Sana clinical study receives their medicine.  You’ll develop and implement supply, labeling, and distribution strategies, working with other experts from Clinical Operations, CMC, Quality Assurance, and Regulatory Affairs.  Cool stuff.

What you’ll do

  • Responsible for end-to-end clinical supply management including forecasting, packaging, labeling, and distribution of Sana’s engineered cells as investigational medicinal products to support Sana clinical studies
  • Responsible for partnership with study teams and 3rd party vendors to monitor progress of on-going and new clinical trials and ensure appropriate delivery of clinical trial material to clinical sites
  • Manage all clinical shipments, including vendor communication, import/export requirements, and any required escalations.
  • Interpret clinical study designs and protocols, and enrollment forecasts to develop clinical labeling, packaging, and distribution strategies, timelines, and budgets
  • Represent supply chain function on cross functional teams; communicate effectively and transparently on status, risks, issues, and strategies impacting supply of clinical trial material to clinical studies
  • Coordinate packaging and labeling activities with contract packaging vendor
  • Contribute to development and testing of IRT systems for management of clinical trial materials
  • Develop procedures, best practices, and work instructions to manager clinical trial materials in Sana’s growing portfolio of clinical studies

 

What we’re looking for

  • Bachelor's degree plus 7+ years relevant experience (or equivalent combination of education and work experience). Significant experience in clinical supply chain
  • Clinical Supply management experience, including management of work performed by 3rd party CMOs and vendors
  • Experience with clinical logistics, including import/export requirements
  • Strong understanding of cGMP and cGCP requirements as they relate to clinical trial materials
  • Ability to solve technical problems that require influencing stakeholders from many technical disciplines and at many levels
  • Ability to work in fast-paced environment where systems and processes are being developed in real time

What will separate you from the crowd

  • Experience with cell therapies
  • Experience with ultra-cold chain logistics and specialty couriers
  • Experience with IRT development
  • PMP or other project management certification
  • CSCP or CPIM certification
  • Experience in biotech or small company environment

What you should know

  • Occasional travel required, <10%
  • The base pay range for this position at commencement of employment is expected to be between $140,000 and $170,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience

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 (various paid time off benefits, such as holidays, vacation, sick time, and parental leave), short- and long-term disability, employer paid basic life insurance, additional voluntary life insurance protection, financial wellness programs including financial planning resources, a 401(k) Plan with an immediately vested employer match, Tuition Reimbursement and Student Loan Repayment, Employee Stock Purchase Plan, commuter subsidy and a variety of wellness offerings to support each person individually.  For more details on our benefits, visit Sana’s Benefits Portal.

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, social class (including caste/caste identity), 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.