Associate Director, External Manufacturing

Sana Biotechnology • Cambridge, MA

9h

About The Position

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 an Associate Director, External Manufacturing you will report to the Executive Director, External Manufacturing to oversee day-to-day operational performance of key Sana contract development and manufacturing organizations (CDMOs). This will include coordinating and driving activities for pre-clinical and clinical phase drug substance (DS) and/or drug product (DP) manufacturing for Sana’s cell and gene therapy programs at 3rd party CDMOs. You will be an essential business partner within Technical Operations and will support Sana's manufacturing strategy to bring Sana's pipeline to patients across the world.

Requirements

• Bachelors degree with 5+ years plus of outsourced clinical and/or commercial manufacturing experience in the biotech/pharmaceutical industry
• Knowledge and understanding of the regulatory guidelines and working experience in the GLP and GMP environment, including knowledge of cGMP quality systems
• Experience operating in early-stage clinical to commercial environments
• Ability to communicate across all levels of an organization and efficiently coordinate activities with both internal and external customers.
• Proven ability to problem solve, build strong relationships, and to organize effectively
• Business acumen with an ability to anticipate operational issues and proactively recommend mitigations/solutions
• Results-oriented and demonstrated focus on achieving business results. Experience with project team meetings, cross-functional communication, supporting decision making, influencing outcomes, and ensuring alignment among internal and external stakeholders
• Successful track record of developing cooperative, productive relationships across all functions with people at all levels within and external to the organization
• High degree of self-motivation
• Ability to quickly adapt to changing business conditions

Nice To Haves

• Prior experience working with cell and gene therapy CDMOs

Responsibilities

• Acts as primary liaison and relationship manager between Sana Technical Operations and the CDMO to ensure timely delivery of high quality pre-clinical and clinical CGT product(s)
• Responsible for adherence to project schedule(s)
• Implement and execute governance structure with CDMO(s)
• Develops and oversees budget(s) for project(s) under their purview, including contributing to internal Sana budgeting activities and ensuring CDMO performance to financial plan in collaboration with Sana accounting.
• Partner with our technical departments to help ensure success of tech transfer activities from Sana to the CDMO partner.
• Monitors technical transfer and production campaign activities and reports on CDMOs performance against plans
• Identifies, notifies, and/or escalates risks and issues that may affect project timelines, resource requirements, finances, or business relationships
• Executes strategies that drive effective operational performance and service levels at contract organizations
• Negotiates and facilitates approval of contracts including proposals, master supply agreements, work orders, and changes of scope.
• Effectively communicates project, performance, and resource issues to management and within project teams
• Ensure CDMOs deliver to support Sana’s business needs including ensuring flexibility to accommodate changing program timelines and compliance with GMP practices as well as Sana's quality expectations

Benefits

• For benefit eligible employees, we cover a generous portion of the cost for employee health coverage, making high-quality care more accessible and affordable.
• We offer ample 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 11-50 employees