Celgene Associate Director, Project Operations, DPD in Summit, New Jersey
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.
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.The Operations Planner position in Drug Product Development, Operations (Drug Product Development – Small Molecule) is focused on expanding, sustaining and improving internal process capabilities and operational infrastructure in support of all DPD facilities. The incumbent will be responsible for the planning and management of multiple infrastructure and equipment projects in support of DPD activities; serve as the DPD interface to Celgene Facilities Engineering and/or Global Pharmaceutical Development Operations (GPDO) Engineering; drive coordination, delivery and installation of equipment and facilities renovations to meet DPD project timing requirements, and interface with scientific and support staff to develop project scope, needs and user requirements. The incumbent will also be responsible for aspects of project planning, design, support estimation, project execution and logistical support activities.
Responsibilities will include, but are not limited to, the following:
Provides leadership, planning and management for DPD facility, infrastructure and equipment projects and serves as a department interface to Celgene corporate Engineering / Facilities and / or Global Pharmaceutical Development Engineering.
In conjunction with DPD leadership, assesses department equipment and facilities needs and develops structured plans in support of department growth and capabilities extensions.
Partners with DPD Leadership and relevant internal / external partners in the review of projects and initiatives with emphasis on strategic value for the organization and broader PS&T functions.
Develops and manages project scope; assists with defining user requirements, execution phasing and resource plans; provides effective and timely communication and milestone reporting; develops risk mitigation plans and follows project issues through to resolution. Coordinates turnover activities and trainings.
Effectively collaborates, communicates vision and partners cross-functionally to obtain support of team members and stakeholders in support of project and departmental goals.
Builds and maintains strong working relationships across DPD, Pharmaceutical Science and Technology (PS&T), GPDO, and other partner groups (e.g. EHS, Finance, Facilities) to achieve effective collaboration and execution on project activities.
Effectively manages project budget and financial reporting: tracks project spend against approved budget.
Provides technical leadership for project installations and associated facility upgrades; adheres to applicable life safety, process safety and engineering principles. Effectively utilizes process, engineering and compliance knowledge in support of installations and facility upgrades.
Interfaces with DPD Operations leads and DPD end-users to define capital equipment / capital projects; coordinates three-year capital plan estimates with Finance; supports annual capital plan submissions, execution, reporting and tracking of changes / deferments / additions / deletions.
Coordinates capital equipment ordering and installations with internal partner groups (Equipment Commissioning and Qualification, QA, EHS, Facilities) and external vendors / mechanical support entities.
Supports assembly of details and preliminary estimates in relation to facility improvements, area renovations, equipment and process train installations.
Supports and interfaces with partner groups for commissioning, qualification testing and preparation of facility for turn-over to DPD staff. Assists with assembly of historical project documentation; assembles procedures and work practices in support of turn-over to end users.
Reviews process efficiencies, provides “lessons learned” to enhance CQI. Conforms to all site Environmental, Health and Safety (EHS), regulatory, quality, and cGMP compliance requirements.
In coordination with DPD leadership, manages DPD office, laboratory, and facility needs. Develops and maintains the DPD space plan.
Serves as a member of the DPD Operations Leadership Team and is a technical and business leader for DPD, PS&T, and GPDO. In conjunction with DPD leadership, guides the department in the efficient achievement of department / area / corporate goals. Grows departmental strategic capability and supports its continuous improvement objectives.
Leadership and Management:
Reinforces the Celgene culture through visible practice of the Celgene behaviors. Drives cultural change, where needed, to ensure alignment company’s vision, values, and purpose.
Develops staff through coaching, training, and other relevant experiences. Enforces a high performing, highly proficient teams.
Project and Portfolio Management:
Operates effectively in a multi-tasking, cross-functional environment.
Develops appropriately proactive resource plans and utilizes staff and other resources effectively to meet department, partner, and company needs. Uses appropriate tools to regularly review, measure, modify, and adjust plans and to monitor the efficiency, effectiveness and balance of resources according to evolving business needs and environment.
Models good decision making practices and assesses and rewards behaviors consistent with good decision making practices.
Displays strong analytical and strategic thinking.
Provides constructive and timely feedback and coaching to enhance personnel performance.
Guides and coaches others effectively in managing through change.
BS (minimum) in Chemical Engineering, Pharmaceutical Science or closely related discipline.
Minimum of 10 years experience in the pharmaceutical industry in small molecule drug product development and GMP manufacture and facility management in support of formulation and process development, scale-up, technology transfer, and clinical supply production.
Demonstrated knowledge and experience in pharmaceutical equipment and engineering considerations across drug product unit operations, processing, and analysis.
Possess strong understanding of drug product technical and manufacturing concepts and techniques, applies and furthers those concepts and techniques to efficiently and effectively resolve technical/manufacturing challenges.
Understanding and application of cGMPs and current regulatory standards in DP manufacturing for global clinical programs.
Strong written and verbal communication skills. Able to influence opinion and share equipment, facility, and operational best practices through effective presentations to internal and external audiences.
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.
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.