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

🕒 Setembro 29

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $108.000 - $164.000 / ano

⏰ Tempo Integral

🟠 Sênior

👷‍♀️ Gerente de Projetos

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Sabin Vaccine Institute

SiteLinkedInTodas as Vagas

51 - 200 funcionários

Fundada em 1993

🏥 Saúde

💼 Consultoria

🍽️ Alimentos e Bebidas

💰 $35.000.000 Grant em 2023-01

Healthcare • Consulting • Food & Beverage

O Instituto de Vacinas Sabin se dedica a melhorar a saúde global, garantindo o acesso a vacinas que salvam vidas. O instituto foca em pesquisa e desenvolvimento de novas vacinas para algumas das doenças mais urgentes do mundo, incluindo cólera, HPV, malária, Marburg e Ebola. Através de programas e parcerias inovadoras, a Sabin busca melhorar as capacidades de imunização e a aceitação de vacinas dentro das comunidades, esforçando-se para tornar a vacinação acessível a todos, especialmente às populações vulneráveis.

Descrição

• 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

🎯 Requisitos

• 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

🏖️ Benefícios

• 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