CMC Project Manager/Senior CMC Project Manager, Research & Development

🔥 13 minutes ago

🇺🇸 United States – Remote

💵 $108k - $164k / year

⏰ Full Time

🟠 Senior

👷‍♀️ Project Manager

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Sabin Vaccine Institute

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 1993

🏥 Healthcare

💼 Consulting

🍽️ Food & Beverage

💰 $35M Grant on 2023-01

Healthcare • Consulting • Food & Beverage

Sabin Vaccine Institute is dedicated to improving global health by ensuring access to life-saving vaccines. The institute focuses on research and development of new vaccines for some of the world’s most pressing diseases, including cholera, HPV, malaria, Marburg, and Ebola. Through innovative programs and partnerships, Sabin aims to enhance immunization capacities and vaccine acceptance within communities, ultimately striving to make vaccination accessible to all, especially vulnerable populations.

📋 Description

• Lead cross-functionally to plan and deliver Chemistry, Manufacturing, and Controls activities across the vaccine development lifecycle • Translate strategy into integrated plans aligned with program objectives, contractual commitments, budgets, and milestones • Coordinate internally and externally with contract manufacturers, laboratories, service providers, and other partners • Establish deliverables, owners, dependencies, and decision points; monitor performance and manage risks • Develop and improve project management tools and practices • Lead day-to-day planning and management of drug product process development service providers • Coordinate deliverables, timelines, dependencies, and cross-functional inputs • Provide updates to Program leadership, governance bodies, funders, and stakeholders • Develop integrated CMC plans, schedules, budgets, resource requirements, and deliverables • Develop and manage logic-linked schedules, critical paths, decision points, assumptions, and schedule risks • Evaluate plans, dependencies, and assumptions; assess impacts of scope, strategy, and assumption changes • Plan and execute meetings to promote alignment, resolve conflicts, accelerate decisions, and maintain progress • Maintain project controls, agendas, meeting minutes, schedules, action and decision logs, risk registers, and milestone reporting • Monitor progress, identify variances, and implement corrective or recovery actions • Coordinate activities across subteams, working groups, contract manufacturers, testing laboratories, consultants, and partners • Communicate decisions, risks, changes, and dependencies to affected stakeholders • Model and reinforce governance, decision-making, and escalation processes • Manage budgets, forecasts, actuals, and variance analysis with Finance, functional leaders, and Earned Value Management personnel • Identify financial, resource, and capacity constraints and develop corrective actions • Support prime contract and subcontractor planning and execution • Facilitate statements of work, requests for proposals, proposal evaluations, service provider plans, basis of estimate, and contract modifications • Manage service providers to deliver contractual milestones, deliverables, and budget expectations

🎯 Requirements

• Bachelor’s degree in scientific, engineering, pharmaceutical, or related discipline • 7+ years of relevant experience in Phase 2 and/or Phase 3 vaccine/biologic project management • Demonstrated skills and experience planning and leading complex, multi-year, integrated product development programs with multiple funding partners and service providers • Working knowledge of the CMC lifecycle from early development through validation, regulatory submission, and commercialization • Experience supporting U.S. Government or other funding partners’ contractually rigorous planning, forecasting, and reporting expectations is strongly preferred • Experience developing and managing integrated schedules, critical paths, dependencies, and recovery plans • Experience managing service providers, including CDMOs, CROs, and testing laboratories • Advanced experience using MS Project and Smartsheet • Experience using Microsoft 365 applications, including MS Teams and SharePoint • Experience with Pharma industry governance practices • Experience with Earned Value Management and project controls • Demonstrated ability to hold teams and service providers accountable in a matrixed environment • 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, listen carefully to feedback and comments from staff, and adapt plans/actions accordingly • Ability to travel approximately 10–20% domestically and internationally with notice • Subject to a criminal background investigation • Request for three professional references • Verification of education/degrees • Commitment to furthering Sabin’s mission • Must be authorized to work in the United States without employer sponsorship • Advanced degree and/or PMP certification preferred

🏖️ Benefits

• Medical, dental, and vision coverage • Flexible spending accounts • Flexible vacation leave • Sick leave • Short-term disability options • Long-term disability options • 10 federal holidays • End-of-year winter break • Employer matching 401(k) plan