Celgene Executive Director, Global Project Engineering & GMP Facilities in Summit, New Jersey

Description

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.

Executive Director, Global Project Engineering & GMP FacilitiesSummit, NJ

Supervisor

VP, Head of Global Engineering

Prerequisites

  • Master Degree in Mechanical Engineering or related field

    • 20 years related experience in pharmaceutical engineering and 10 years managerial experience

Prerequisites

Master Degree in Mechanical Engineering or related field.

  • 20 years related experience in pharmaceutical engineering and 10 years managerial experience.
  1. Competencies

This position is responsible to manage the Engineering, Maintenance, Calibration and C&Q services for all GMP GPDO facilities in US locations (Summit, Warren and Seattle). He assures compliance of these activities with cGMP as well as with internal policies and procedures.

The incumbent is responsible for site master planning, facility and technology development, capital project management, long range capital and operational expenses budget planning and management. The individual sets objectives for and manages multiple projects and ongoing work activities of high complexity to ensure on time and within budget completion.

This position will be working closely with the GPDO organization.

This position will have to deal with strategic decisions that will impact the entire Celgene activity.

  1. Skills/Knowledge Required
  • Strong experience in the project management of complex infrastructures.

  • Strong experience in technologies and infrastructures

  • Solid knowledge of GMP and FDA regulatory requirements.

  • Solid knowledge in the validation of procedures and systems.

  • Flexibility and ability to multi tasks.

  • Excellent written and verbal communication skills.

  • Excellent organizational and time management skills.

  • Advanced team work and facilitation skills.

  • Ability to develop others, delegate and motivate.

  • Strong critical reasoning and decision making skills

  • Strategy thinking and ability to work independently.

  • Environmental, industrial hygiene and safety regulatory knowledge is required.

  • Ability to deal appropriately with regulatory authorities.

  • Demonstrated ability in financial management, leadership and systems thinking.

  1. Duties and Responsibilities

Responsibilities will include, but are not limited to, the following:

  • Ensure maintenance and calibration of qualified equipment and validated system in compliance with cGMP as well as with policies, guidelines and procedures.

  • Ensure development of equipment calibration/maintenance programs, validation plans, qualification protocols, associated reports and procedures.

  • Ensure the implementation of global engineering process standards and project documentation; scoping documents, RFP’s, CAR’s, budget tracking, scheduling, commissioning, qualification and project handover.

  • Manage several major investment projects.

  • Ensure proper execution of activities associated with major investment projects including:

    >Feasibility study >Preliminary engineering and cost estimates >Development project scope and capital expenditure approval documents
  • Lead (direct or matrixed) one or more staff, in terms of mentoring, guiding and developing individuals to meet goals. This includes training and leading projects managers in technical skills, project management skills and customer management skills.

  • Accountable for project budgets and timelines.

  • Provide leadership to the project team to anticipate and identify complex projects issues which pose a challenge to achieving goals; propose plans to resolve such issues quickly.

  • Ensure that appropriate GMP and GEP documentation is established to document all activities (procedures, drawings...).

  • Initiates, manages and leads cross-functional/cross-site projects of medium to large scope and complexity.

  • Drive complex communications that are efficient, effective and timely. Ensure that all customers are fully informed and knowledgeable of project activities and their status.

  • Overseeing GMP and Regulatory compliance with FDA and Pre-Approval Inspections requirements.

  • Accountable for Carbon Management (LEED certifications) in new projects development and site master planning.

  • EHS:

    >Line Managers shall maintain a safe and healthy work environment for their staff in areas under their control, and shall ensure compliance with relevant rules and legislation in those areas. >Work with EHS to evaluate hazards and perform risk analysis. >Ensure that staff (including short duration and temporary contracts) is properly informed on hazards, and trained to act in consequence. >Promote safe practices and behaviors, verify EHS rules are implemented and respected. >Report immediately all incidents and near-misses to EHS, participate in investigations and identify preventive measures to prevent similar accidents in the future.

General and Leadership:

+ Leads with a global mindset.

+ Leads and serves as the role model for an organizational culture that embraces respect and collaboration, passion and engagement, trust, integrity and accountability, innovation and growth, quality, productivity and continuous improvement.

+ It is expected that incumbent will continue to grow organizational capability and acquire experience/expertise in new technology areas to reflect the expanding Celgene product platforms

+ Responsible for developing the appropriate KPIs and executive dashboard in alignement with goals, objectives and strategy.

+ Advocates for discipline excellence by partnering closely with internal and external stakeholders to improve customer service and develop and capture industry-competitive best practices.

  • Influence enterprise-wide business decisions through the on-going leadership of the Capital review process. Willing and able to work hands-on and with a sense of urgency, in a fast-paced, entrepreneutial environment.

#LI-POST

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.COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE

At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.

“At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients.”

There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.