Project Manager: CMC Drug Development
Successful candidates will have both scientific experience in CMC drug development and formal training in Project Management. These individuals must have a scientific background in either Pharmaceutical Supply Chain, Drug Substance, Drug Product or Analytical work streams in the pharmaceutical industry as well as training in the core principles of the disciple of project management.
- 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.
- An 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
- 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
- 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 GSK R&D 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.
Who Are We - GSK?
We are a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. GlaxoSmithKline plc was formed in 2000 as a result of a merger between Glaxo Wellcome plc and SmithKline Beecham plc , although our history can be traced back more than 300 years to London’s Plough Court Pharmacy in the 1700s.
Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies.Our strategy is to bring differentiated, high-quality and needed healthcare products to as many people as possible, with our three global businesses, scientific and technical know-how and talented people.Our values and expectations are at the heart of everything we do and form an important part of our culture:
Our values are Patient focus, Transparency, Respect, Integrity
Our expectations are Courage, Accountability, Development, Teamwork– Establish ways of working and ensure EDMO requirements are built into the different JV plans (there is not one plan)