Other Locations:US- NJ- Summit West
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
Principal Project Engineer
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives.
Our purpose as a company is to discover and develop therapies that will change the course of human health.
We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
This position in Global Engineering will provide project management and leadership skills to a combination of Biologic Project Management Processes and high innovative Product Development Programs.
Responsibilities associated with Biologic Processes include driving, managing, evaluating and maintaining key strategic or operational activities that influence decision making around specific global business objectives.
Responsibilities associated with Biologic Programs include translating product/program strategy into efficient executable plans, leading multidisciplinary (clinical, manufacturing, regulatory and commercial) teams in planning solutions to achieve successful execution.
Acts as an internal, subject matter expert (SME) with respect to specific USP / DSP development/ technical processes and the discipline of Project Management.
Responsibilities Will Include, But Are Not Limited To
- Leads the project planning efforts of the respective Project Team in defining and implementing the operational project plan.
- Manages the project scope, execution strategies and critical paths. Manages the development and tracking of detailed project plans, including schedules, cost estimates, resource plans, communication plans, risk mitigation plans, and issue resolution plans with an emphasis on GPT strategy
- Partners with GPDO leadership and relevant committees in review and tracking of project with an emphasis on strategy.
- Proactively manage changes in project scope and create contingency plans in a constantly changing environment.
- Manage the identification of potential issues or obstacles and achieves resolution or plans contingencies and follow issues through to resolution ensuring that all team issues arrive at a singular conclusion or recommendation.
- Generate and maintain the project plan with input from the project team, including a resource-loaded Gantt chart
- Identifies and proactively drives high quality project deliverables, dependencies, and critical path items.
- Management responsibility for programs includes matrix management of multi-disciplinary, cross-functional, global team members.
- Generates collaboration, cooperation, and communication across and between functional team members obtaining buy in of all team members to integrated product strategy.
- Manages project financial reporting and tracking budget to actuals.
- Communicate, coordinate, and negotiate with internal and external partners on project progress and work with the GPDO Senior Management to balance operations execution with project strategy managing through project changes and milestone delays.
- Manages project status reporting including development and maintenance of project documents and communication tools.
- Provide technical leadership and support for Biologics commercial and late clinical stage product portfolio.
- Technical bridge between Process Development and site based Technical Operations groups to support technology transfer, process validation, control strategy, process knowledge and ownership.
Minimum of 10 years industrial experience in Biologics Development / Manufacturing and Project Management ; with at least 5 years of relevant experience in large-scale Biologics / Biotechnology manufacturing including fermentation, cell culture, and purification and finish drug operations.
Excellent knowledge of biologics development and manufacturing related scientific disciplines
- B.A. / B.S. required. M.S. Advanced degree, specifically in biological sciences is preferred.
- Minimum of 10 years' project management experience in the biotechnology or pharmaceutical industries, in a multi-disciplinary, global environment.
- Minimum of 5 years people management experience and/or proven leadership experience in managing a global, matrix team.
- Knowledge and understanding of product development processes, preferably in biologics, regulatory pathways for biologics (e.g. FDA, EMA), and knowledge of cGCP, cGLP and cGMP.
- Proven leadership, team building skills and strategic problem-solving ability. Ability to manage and lead others through change. Demonstrated ability at managing matrix teams, influencing outcomes and key project decisions
- Experience interacting with external collaborators with ability to build strong relationships.
- Knowledge of risk management, project reporting, and project management tools required.
- Strong interpersonal skills particularly motivational, negotiation, listening, judgment, analytic, and conflict management skills, demonstrated by ability to lead teams.
- Excellent organization, verbal and written communication skills to explain project goals and inspire support.
- Ability to work effectively in a fast paced, rapidly changing technology environment, and to work on multiple work streams and projects simultaneously.
Demonstrated time-management organizational skills.
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.