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Precigen · 2 weeks ago

Associate Director Project Management CMC

Germantown, MD

Full-time

Onsite

Lead/Staff, Director/Executive

5+ years exp

Precigen is a biopharmaceutical company focused on advancing gene and cell therapies. The Associate Director will manage CMC focused project teams, develop integrated project plans, and ensure timely delivery of drug manufacturing projects by collaborating with various stakeholders.

BiotechnologyLife ScienceMedicalTherapeutics

Diversity & Inclusion

Responsibilities

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

Qualification

CMC project managementManufacturing experienceDrug development programsAlliance ManagementProject Management ProfessionalTechnical schedulingAnalytical thinkingInterpersonal skillsAttention to detailCommunication skills

Required

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

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

Preferred

Program Management Professional (PgMP) or Project Management Professional (PMP®) certification desirable

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