Associate Director Project Management CMC

GENERAL DESCRIPTION:

Reporting to the Senior Director of Project Management, the Associate Director will be accountable for developing, communicating and driving the execution of fully integrated and cross functional drug manufacturing plans and timelines to meet commercial demand. Building strong partnerships with External and Internal stakeholders across CMC, Supply Chain, Regulatory, Quality, R&D, Facilities and Commercial is critical for this role to ensure milestones are advanced in alignment with company priorities and commitments. Having a voice on the team, the Associate Director will be empowered to challenge the status quo, reinforce team accountabilities, and offer innovative solutions to maximize operational efficiencies in drug manufacturing practices. Regular reporting to Executive Leadership on project plans, schedules, and risk mitigation approaches is expected.

DUTIES AND RESPONSIBILITIES:

Project Management

• Manage and supervise CMC focused project teams.
• Define and communicate team roles and responsibilities, scope, goals and deliverables in collaboration with senior management and stakeholders.
• Develop and execute integrated project plans and information management practices.
• Regularly challenge timelines and offer 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 members of the Legal and Finance departments to ensure concurrence with budgetary, intellectual property and other legal and fiduciary requirements.
• Develop and implement procedures for project monitoring to include team meetings, daily stand ups, individual 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, OTLs, etc.) and challenge delivery timelines of goods and services.
• Efficiently manage and maintain a system of problem resolution (i.e., change in project scope, requirements, deadlines, etc.).
• Drive resolution of project conflicts by consulting with project teams and stakeholders in developing strategic and executable solutions.
• Provide weekly project reports.
• Serve as Operations representative on internal teams and focus groups including and not limited to Safety and Facilities Planning.
  
  

EDUCATION AND EXPERIENCE:

• B.S / M.S. in Science, Biological Engineering or Biotechnology.
• Five (5) + years of Manufacturing, CMC experience preferably Biologics
• Five (5) to seven (7) years CMC project management experience, or 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, able to easily pivot to meet changing demands of the business.
• Excellent interpersonal skills with the ability to lead, focus, negotiate, resolve conflict and drive consensus across internal and external functions and levels.
• Mastery in technical scheduling, scenario planning and reporting from project management tools, such as Microsoft Project, or Smartsheet is a must.
• Excellent analytical thinker with exceptional planning, organization, and execution skills.
• Demonstrated ability to identify, prioritize and resolve key project and partnership issues.
• Ability to anticipate and solve problems while analyzing complex issues and environments.
• Strong attention to detail and excellence in project management, while effectively managing multiple projects/priorities.
• Strong oral and written communication skills and an ability to communicate complex concepts in a concise, simplified manner.
• Demonstrated ability to work with and coordinate demands from multiple internal and external stakeholders.
• Ability to effectively prioritize, reprioritize and execute in a high-pressure, milestone-driven, and rapidly changing environment is critical to the role.
• Exhibition of the highest degree of ethical standards and trustworthiness.
  
  

EOE MFDV

Precigen (Nasdaq: PGEN) is a dedicated discovery, commercial and clinical stage biopharmaceutical company advancing the next generation of gene and cell therapies using precision technology to target the most urgent and intractable diseases in immuno-oncology, autoimmune disorders, and infectious diseases. We invite you to discover more at www.precigen.com .