Associate Director, CMC Project Management

Sana Biotechnology • Cambridge, MA

7h • $165,000 - $205,000

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 a CMC Project Manager, you will report to Sr. Director, Supply Strategy. You will work directly with our CMC team leads to develop and deliver CMC project plans and with our functional leaders to improve our efforts to deliver a complex, innovative CMC portfolio. You will help us target those small details that unlock big successes and replicate them across programs.

Requirements

• Bachelor’s degree in relevant science or engineering field
• At least 6+ years’ experience in pharmaceutical or life sciences industry including 4+ years of CMC development or CMC project management experience
• Experience taking programs to INDs and pivotal INDa submission.
• Expert knowledge of Project Management methodologies, concepts, and tools
• Track record of working in matrix organization and influencing across multi-site, multi-function program teams
• 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

Nice To Haves

• Experience with Cell and Gene Therapy CMC development
• Portfolio or multi-program PM experience
• PMP certification
• Lean Six Sigma or other certification in Operational Excellence

Responsibilities

• Develop a master project plan using MS Project or Smartsheet. Based on task interdependencies, define CMC project critical path and establish monitoring mechanisms to align and correct any schedule modifications that impact the critical path.
• Publish regular dashboards to align team on project progress and any modifications to the critical path. Support the CMC team on enabling decisions and risk management.
• Partner with CMC Team Leaders to set and monitor CMC strategy and team goals. You will create and maintain the cross-functional CMC project plan and keep team activities and timelines on track.
• Support assembling and maintaining key CMC information to guide CMC execution (e.g. QTPP, risk assessment, decision and action item logs, etc.)
• Identify potential CMC risks, resource constraints, and conflicts that could impact program timelines; work with CMC lead and team members to develop and execute functional mitigation strategies, and to identify and develop options for CMC risks that rise to program level impact.
• Deliver consistent and high-quality CMC program management services to enable CMC team, overall program and project success by being strategic in project planning, team management, and process management.
• Ensure close collaboration and great communication with core program team PM to ensure that CMC plans deliver Sana program priorities and that critical path risks are identified, escalated, and resolved fast
• Help improve communication and help CMC teams learn from one another so that CMC teams and functions work together effectively to deliver Sana’s new medicines to patients

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