Global Project Manager - CMC Pharmaceuticals

Alphanumeric Systems, Inc.

  • Waltham, MA
  • Contract
  • Full-time
  • 1 month ago
Alphanumeric is hiring a Project Manager with drug substance, drug product, analytical or supply chain aspects of drug development to work in Waltham, MA with one of the largest pharmaceutical companies in the world. Prior experience working on CMC (Chemistry Manufacturing and Control) aspects of pharmaceutical products are a requirement for this role. Responsibilities Work with technical project team members to build a non-clinical drug development plans using a defined work package library. Facilitate conversations to clarify interdependencies of work packages across the various technical work streams. Create, monitor and control accurate and integrated project plans against which resource demand is realistically forecasted and understood to enable decision making (e.g. establish and manage budgets and resource for both outsourced and internal activities.) Influence direction of project development utilizing data, scenario planning and insights to aid decision making. Conduct periodic health checks of the Plans to ensure quality of project planning and control. Provide credible data, insight and recommendations to enable cross portfolio reviews and to facilitate project and resource prioritization discussions. Ensure a risk management plan is active and routinely discussed in the matrix team. Comply with all corporate governance requirements, such as project information documentation and retention and compliance training. Complete training and maintain competence against the project management curriculum including PMP or PRINCE2 certification. Maintain awareness of Project Management practice in the pharmaceutical and other industries. Required Knowledge Education Previous Experience Minimum Level of Education BSc with experience in the development or manufacture of pharmaceuticals area of Specialization chemistry or biochemical engineering Preferred Level of Education MSc and deep understanding of all aspects of developing a pharmaceutical, the manufacturing requirements and some knowledge of the pharmaceutical industry, regulations and requirements are important in this role Job-Related Experience Knowledge and experience with the technical packages that are required to deliver a new small molecule, biopharm or cell gene therapy medicine, whether from a Supply Chain, Drug Substance, Drug Product or Analytical background. Ability to lead and influence matrix projects teams in the design and execution of project plans including utilization of resources (FTE and external budget). A performance-driven individual, with a strong sense of urgency, exceptional organizational credibility, and deep understanding of the business. Demonstrated knowledge and application of skills in all relevant components of project management, including management of scope, time, cost, quality, integration, influence negotiation, communications, risk, and scenario planning across all project management focus areas (initiating, planning, executing, monitoring and controlling, and closing pharmaceutical RD projects). Practical experience in a previous project management role and, ideally, certification in PMP, APM or PRINCE2. Demonstrated ability in relevant soft skills including change management, continuous improvement, conflict resolution and consensus building.