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Precigen

Associate Director Project Management CMC

Precigen, Germantown, Maryland, us, 20875

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Overview

Associate Director Project Management CMC – Join the team at Precigen to lead the development, communication, and execution of fully integrated, cross-functional drug manufacturing plans and timelines to meet commercial demand. Build strong partnerships with External and Internal stakeholders across CMC, Supply Chain, Regulatory, Quality, R&D, Facilities and Commercial to advance milestones in alignment with company priorities. The role offers an opportunity to challenge the status quo, reinforce team accountabilities, and propose innovative solutions to maximize operational efficiencies in drug manufacturing. Regular reporting to Executive Leadership on project plans, schedules, and risk mitigation approaches is expected. Duties and Responsibilities

Manage and supervise CMC-focused project teams. Define and communicate team roles, scope, goals, and deliverables with senior management and stakeholders. Develop and execute integrated project plans and information management practices. Regularly challenge timelines and propose innovative approaches to minimize risks to milestone delivery. Communicate project modifications to impacted parties with explanations of new responsibilities, deadlines, target dates, etc. Coordinate with Legal and Finance to ensure concurrence with budgetary, IP, and other legal/fiduciary requirements. Develop and implement procedures for project monitoring, including team meetings, daily stand-ups, action item follow-up, and meeting minutes. Manage workflow requirements and documentation related to the projects. Interface with executives/department leads for strategy and budgeting purposes. Manage external collaborations (CDMOs, CMOs, OTMs, etc.) and challenge delivery timelines of goods and services. Efficiently manage and maintain a system of problem resolution for changes in scope, requirements, or deadlines. Drive resolution of project conflicts by consulting with project teams and stakeholders to develop strategic, executable solutions. Provide weekly project reports. Serve as Operations representative on internal teams and focus groups, including Safety and Facilities Planning. Education and Experience

B.S. / M.S. in Science, Biological Engineering or Biotechnology. Five (5) or more years of Manufacturing, CMC experience, preferably Biologics. Five to seven (5–7) years CMC project management experience, or a combination of education and experience. Alliance management with service providers (CMOs, CROs, research institutions, etc.). Strong experience working with Pharma/Biotech on complex drug development programs. Program Management Professional (PgMP) or Project Management Professional (PMP) certification desirable. Desired Key Competencies

Independent, enthusiastic, and motivated to directly impact the manufacture of new life-changing medicines for patients. Technical experience in drug manufacturing or engineering as SME or CMC project manager. Agile, with ability to pivot to changing business demands. Excellent interpersonal skills to lead, focus, negotiate, resolve conflict, and drive consensus across internal and external functions and levels. Mastery in technical scheduling, scenario planning, and reporting using project management tools (e.g., Microsoft Project or Smartsheet). Strong analytical thinking with exceptional planning, organization, and execution skills. Ability to identify, prioritize, and resolve key project and partnership issues. Ability to anticipate and solve problems in complex environments. Attention to detail and excellence in project management while managing multiple priorities. Strong written and verbal communication skills to convey complex concepts clearly. Ability to coordinate demands from multiple internal and external stakeholders. Ability to prioritize, reprioritize, and execute in a high-pressure, milestone-driven, rapidly changing environment. Highest ethical standards and trustworthiness. Equal Opportunity Employer

EOE MFDV. Precigen (Nasdaq: PGEN) is a dedicated discovery, commercial and clinical-stage biopharmaceutical company advancing gene and cell therapies using precision technology to target urgent diseases. For more information, visit www.precigen.com.

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