Pharmaceutical Manufacturing Project Manager with Product Launch experience:
Alpha Consulting

Alpha Consulting
Gaithersburg Mary

Ideal Candidate Profile:
Please avoid R&D or IT PMs for this posting. The ideal candidate would be a Manufacturing PM with experience in pharmaceutical product launches, BD, Tech transfers in a commercial environment (not R&D) and also working with CMOs.

Project Description:
Manage franchise, enterprise, strategic, large, complex projects or workstreams across multiple sites, functions, and regions within the Global Biologics Operations Program Management Office (PMO). Accountable for application of industry-standard project management methodology, tools, and processes to ensure successful team execution, project delivery and ways of working. Interface with other Biologics Operations and AZ functions, manufacturing sites, site PMO leads, other PMs, CMC teams, subject-matter experts, key stakeholders, functional leads, contract manufacturing organizations, and outside testing labs. Responsible for effective project team management, governance, prioritization, resource planning, training, and monthly reporting as they apply to assigned projects and new and improved processes. Reports to the Project & Portfolio Analytics Lead in the Biologics Operations PMO.
  • Manages Global Biologics Operations strategic projects utilizing the PMO project methodology, tools, and processes, to meet agreed scopes, timelines, deliverables, budgets, resource estimates and success criteria.
  • Manages functional and cross-functional project teams to deliver successful projects.
  • Interfaces with sites, functional heads, other functions, and other key stakeholders to assure continuous alignment of priorities.
  • Applies effective problem-solving individually and with the project team to address challenges encountered in successful project delivery. Escalates issues appropriately to the sponsor, key stakeholders or PMO management.
  • Proactively identifies and shares relevant best practices to improve project delivery and PMO team capabilities.
  • Actively pursues continuous improvement with focus on simplification, standardization and lean.
  • Proactively manages risks to project delivery and the business. Takes appropriate risks and consults appropriately.
  • Tracks and reports on the progress of assigned projects to the sponsor, appropriate governance, stakeholders, and senior management.
  • Provides necessary information and insight to the project sponsor to support project stage-gate reviews, approvals and project updates to appropriate governance forums, steering committees, and/or stakeholders.
  • Ensures all key stakeholders are kept appropriately always informed of project status.
  • Trains project teams and members as needed on project management tools and governance processes.
  • Understands the larger project portfolio(s), identifying and resolving potential resource conflicts, and prioritizes appropriately to ensure successful delivery of the franchise/domain strategy.
  • Manages project budgets, expenses, and resources to meet estimates and commitments.
  • Helps drive the objectives of the Biologics Operations PMO team and the broader Biologics Operations PMO community

Required Skills:
  • BS in Engineering, Science or Operations field, with 5-10 years of Project Management experience
  • MS, MBA, or other advanced degree preferred.
  • Minimum 2 years' experience in the pharmaceutical, biopharma or GMP industry; must be familiar with pharma or biopharma GMP.
  • Demonstrated track record of success in managing strategic, complex, cross-functional, and multi-site projects on-time, on-budget and to committed deliverables, to generate significant business value.
  • Takes appropriate initiative and accountability, demonstrating both entrepreneurial spirit and a collaborative mindset.
  • Strong interpersonal, influencing, motivation and communications skills.
  • Strong team management skills
  • Comfortable with ambiguity and fast pace
  • 5 years minimum experience in the pharmaceutical or biopharma industry in a manufacturing, technical or related role
  • Technology transfer, manufacturing scale-up, new product development or launch experience.
  • Manufacturing, R&D, QA, or analytical testing experience
  • Strong knowledge of pharmaceutical/biopharma GMP
  • Experience in Biopharma Operations a plus but not required.
  • Experience working globally, leading virtual teams in a matrixed environment.
  • Experience presenting to or communicating with senior management.
  • Project Management certification (PMP)

This 12+month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: