Preclinical Project Manager

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Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

Preclinical Project Manager

The Project Management Office (PMO) is part of the Janssen R&D organization. Their mission is to bring the right products to patients by driving R&D Programs and portfolio decisions through integrated time, scope risk, resources and people management.
Within Discovery Sciences, PD&S is responsible for the assessment of the preclinical safety profile of internally and externally generated small molecules (and vaccines) starting in the discovery phase up to post-approval support. Among the major, critical capabilities are integrated drug development support and global submissions, pharmacokinetics, dynamics and metabolism, bio-analysis, isotope synthesis, PK/PD modeling, toxicology/pathology, mechanistic and investigative safety and laboratory animal medicine support.

The Senior Manager, PD&S Project Manager provides project management support to Pre-Clinical Development (PCD) Leaders and PCD teams. This includes:

 
• building project timelines
• developing and analyzing scenarios, risk assessment and mitigation planning
• developing project budgets
• developing resource needs (FTE’s = Full Time Equivalents) with PD&S functions
• tracking and reporting actualization of project timelines, budgets and FTE’s.
The Senior Manager, PD&S Project Manager provides support for continuous forecasting, quarterly financial updates, development of Business Plan Budgets and FTE’s and preparation for Governance Meetings. He/she is a member of the PD&S team (sub team of Compound Development Team) and works with the team and with PD&S functions to facilitate successful project execution, achievement of key deliverables and of budget and FTE goals. As a member of the Project Management Team he/she supports cross-functional planning, budgeting and resourcing activities.
The primary responsibilities include:
• be an active member of assigned PD&S Teams
• build and maintain project plans
• Develop forecasts regarding project resource needs (OOP’s and FTE’s)
• Track actual expenses and FTE’s against forecasts
• Liaise with project finance, program management and customer groups from Janssen R&D organization.

Qualifications Education :

• Bachelors Degree in Scientific Discipline (A Master’s Degree is highly preferred).

Experience :

• Minimum of 6-8 years experience in the pharmaceutical industry. • Knowledge of Pharmaceutical Development and Clinical Development. • Experience in Project Management. • Capability in the Microsoft suite of business software including MS Project, Visio and Excel. • Experience in working in multinational/multicultural organizations. • Prior Pre-Clinical Development / PD&S experience (preferably minimum of 2 years) • Knowledge of project management tools and techniques. Prior experience with Planisware is desirable Critical Competencies • Communication • Customer focus • Collaboration and teaming • Be able to work in a highly matrixed organization • Results and performance driven

RESPONSIBILITIES: 

• Candidates will work with fellow scientists to designing and executing experiments including small-scale studies, and pilot plant and manufacturing studies in a variety of types and scales of equipment from bench top to pilot-scale, and, as required, technology transfer and validation in commercial plants. 

• Based on the analyses of these studies, these positions will be expected to develop and test new hypotheses to improve fundamental understanding of the chemical and biochemical processes, including bio-conjugation or large and small molecule combinations. 

• This position will support process validation, quality by design, regulatory approaches, and quality systems 

• This position requires a highly motivated individual with the ability to work closely with other members of the laboratory and the department in a matrix environment. 

• This position will also collaborate with the pilot plan and manufacturing staff on experimental studies, clinical manufacturing, and process validation, including work with external contract manufacturing organizations