Softworld Senior Project Manager in Waltham, Massachusetts
Senior Project Manager
Employment Type: Contract
Industry: Life Sciences
Job Number: 232553
Title: Senior Project Manager Duration: 1 year Location: Waltham, Massachusetts
Ask the following questions: 1. Does this person have experience working on CMC (Chemistry Manufacturing and Control) aspects of pharmaceutical products? o Specifically comprising experience with drug substance, drug product, analytical or supply chain aspects of a drug development project; whether in Small Molecule or Biopharm modalities. o Note the following does NOT fit the requirement: management of clinical trials, IT project management, facilities project management.
- Does this person have some genuine project management training (certification is preferred)? o Many CV’ s make project management claims that are not substantiated by career history (there is a difference between “ having a job that requires some degree of organization” and being a “ project manager”); if we speak to candidates and they cannot substantiate their PM claims it doesn’ t reflect well on them.
If the answer to questions 1 and 2 is ‘ yes’, they could be a strong candidate. If the answer to question 1 is ‘ yes’ but the answer to question 2 is ‘ no’ then they are unlikely to be a viable candidate.
The Role: 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.
Key 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.
Knowledge/ Education / Previous Experience Required*
• Educational Background o Minimum Level of Education* BSc with experience in the development or manufacture of pharmaceuticals • Area of Specialization* chemistry or bio/chemical engineering • Why is this Level of Education Required? 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 o Preferred Level of Education MSc • Why is this Level of Education Preferred? An 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 • Describe what experience this position will require the job holder to have obtained in past roles within or outside of GSK that would demonstrate a level of proficiency in the stated role.
Minimum Level of Job-Related Experience required • 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.