CMC Project Manager / Senior CMC Project Manager (R&D)

Reports to: Director, Project Management, Research & Development

Location: Remote Work (US Only)

Why Sabin:
 

Our mission is to make vaccines more accessible, enable innovation and expand immunization across the globe. We seek a future free from vaccine-preventable diseases. We are an innovative, collaborative, and engaged team that values accountability, teamwork, partnership and driving impact. We are vaccine champions improving lives through immunization. Sabin staff, management and the Board of Trustees are committed to ensuring that fairness, integrity, and opportunity remain at the core of how we operate.

Position Summary: 

As a Chemistry, Manufacturing, and Controls (CMC) Project Manager within Research & Development (R&D), you will lead project teams and drive the initiation, planning, and execution of CMC activities across all phases of vaccine development. You will lead and integrate cross-functional project teams, vendors, consultants, and external stakeholders (partners, federal agencies, global health organizations, etc.) ensuring deliverables are achieved and aligned with development program timelines and milestones.

First-hand vaccine/biologics product development Project Management experience inclusive of strategy, planning and execution, as well as advanced knowledge of resource, scope, schedule, cost, quality, and risk management are required for this position. Additionally, technical experience and operational fluency in at least two of the following areas are required:

• Viral vectored vaccine development
• Drug substance process development activities including scale up, tech transfer, validation, stability, and commercial-scale manufacturing
• Drug product process development activities include scale up, tech transfer, validation, stability, and commercial manufacturing, inclusive of labeling and packaging
• Analytical method transfer and validation

Responsibilities:

Project and Program Management fundamentals:  

• Partner closely with Program leadership for the establishment of strategies, plans, schedules, and budgets, and subsequently ensure delivery upon these pillars
• Lead high-impact meetings to align stakeholders, drive progress-to-plan, resolve conflicts, and accelerate decision-making; coordinate, manage, and publish agendas and meeting minutes for both internal and external meetings 
• Develop and manage detailed project budgets and timelines. Partner with Finance and Earned Value Management team to monitor forecast vs. actuals, track accruals, and support variance analysis. Provide proactive feedback and corrective measures to leads on their financial and schedule performance. Manage cross-functional resource coordination to avoid timeline disruptions.
• Serve as a role model and uphold principles of Program Governance
• Compile, maintain and actively manage risk by fostering a culture of risk management and leading team in the identification and mitigation of risks and opportunities
• Manage reporting (weekly, bi-weekly, monthly, annual) for internal and external purposes, including contractual obligations
• Support the planning and delivery of organizational objectives and goals to ensure successful R&D-wide evolution in support of our mission and advancement of our vaccine product development programs
• Develop and refine project management tools which foster alignment, communication, and performance

CMC Planning and Integration:

• Partner with CMC functional leads to facilitate strategic planning, coordination, and integration across sub teams, working groups, vendors, and contractors to ensure alignment and sequencing of activities with program timelines, development plans, and regulatory milestones

Manufacturing and Development Oversight and Execution:

• Partner with internal and external manufacturing and development teams to ensure production planning and readiness, equipment qualification, batch release schedules, and supply chain continuity across drug substance and drug product
• Facilitate cross-functional discussions with external partners and resolve technical or operational issues

Tech Transfer and Lifecycle Management:

• Support tech transfer planning and execution between manufacturing and analytical sites, including facility readiness, process fit assessments, and scale-up strategies
• Provide leadership for post-approval CMC changes and lifecycle management plans

GMP Compliance and Quality Integration:

• Interface with Quality to ensure GMP compliance, CAPA implementation, and audit readiness; track and escalate issues as necessary to minimize impact on timelines or product quality

Regulatory Filings:

• Manage timelines and content delivery for CMC sections of regulatory filings (e.g., IND, IMPD, BLA, sBLA), ensuring alignment with global regulatory expectations and supporting response strategies to Health Authority Information Requests

• Bachelor’s degree in a scientific field; advanced degree and/or PMP certification preferred
• 7+ years of relevant experience in project and program management; demonstrated skills and experience in planning and leading complex, multi-year, integrated vaccine/biologic product development programs with multiple funding partners and vendors
• Experience managing third-party vendors, including CDMOs, CROs, and testing laboratories
• Experience implementing monitoring and evaluation tools 
• Experience with Governance practices within pharmaceutical industry
• Experience with Earned Value Management and project controls of vaccine/biologic project and program schedules and budgets
• Advanced experience using MS Project, Smartsheet, and/or other project management tools
• Advanced experience using Microsoft 365 applications, including MS Teams and SharePoint
• Ability to work across the organization and build strong relationships with colleagues, managing their expectations
• Strong communication and interpersonal skills; ability to be flexible and optimistic
• Strong attention to detail, ability to manage complex tasks, highly organized, dependable and able to prioritize competing demands to meet deadlines
• Ability to process information quickly and listen carefully to feedback and comments from staff and adapt plans/actions accordingly
• Commitment to furthering Sabin’s mission
• Ability to travel approximately 10-20% domestically and internationally with notice 

Other:

• Subject to a criminal background investigation
• Request for three professional references
• Verification of education/degrees

Sabin’s philosophy is to ensure fair, unbiased, equitable, competitive compensation and benefits. Using benchmarking and salary survey data, the starting annual salary for this position ranges from $108,000 - $164,000. The exact compensation may vary based on skills, experience, training, certifications/degree. As a grant-funded organization, Sabin actively seeks funding for existing and new programs.

Sabin offers a competitive benefits package that includes Medical, Dental, Vision and Flexible Spending Accounts. Employer paid, Life and Disability insurance along with 11 paid holidays with a winter break between Christmas and New Years. Employer match on 401(k).

Sabin is an Equal Opportunity Employer. All applicants will be considered for employment without attention to their race, color, religion, national origin, ancestry, age, disability or genetic information, sex (including gender identity, pregnancy or sexual orientation), marital status, veteran status, or any other characteristic protected by applicable federal, state or local laws