Celgene Executive Director, Site Head of Warren Manufacturing in Warren, 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.
PURPOSE AND SCOPE OF POSITION:
The Site Head of Warren Manufacturing is accountable for the delivery of clinical material on time in full, the exploration of Cellular Therapy new technology, and the implementation of the Cellular Therapy Manufacturing Site Blue Print, site P&L, business continuity plan, 3-year operating plan, and GMP operations at the Warren facility. Site Head will develop annual objectives for the site and will directly manage Manufacturing (Logistics, Media Prep, Operations, Compliance), Supply Chain (Warehouse, Production Scheduling, Master Data Management, Material Handling, Site Procurement), MS&T (Floor Support, Automation/MES, Process Eng./Tech Transfer), Business Operations (PMO, OPEX, Office Management), F&E and EHS. Site Head will matrix manage Quality Assurance, Quality Control, IT, HR, and Finance. Site Head is accountable to ensure assure product supply meets clinical demand and product quality meets conformance with specifications, regulatory, and safety compliance. Site Head will champion continuous improvement projects to develop site into a best in class, multi-product facility, will promote operational excellence at all levels of the organization, and will serve as member of the Global Manufacturing Leadership Team. Site Head will serve as Warren manufacturing strategy lead at JPT and JSC governance meetings with external business partners.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities
Must have leadership skills required to prioritize site work, ensure engagement of cross-functional organization, and manage large number of reports in matrix operating environment.
Must have experience hiring & developing talent, leading by example, and building high performing teams in a cross-functional organization.
Must have good strategy development, project management and business acumen to develop site operating plan and manage financial budget. Must be able to direct a portfolio of projects for the multi-product facility.
Must have expert GMP, Quality, and risk management knowledge that supports the department and global function.
Must be able to critically interpret problems and effectively communicate in an impactful manner to management, and the broader organization with clarity and a high level of brevity and accuracy.
Must be a technical/scientific expert. Must be able to direct cross functional team through complex technical problem-solving exercises and drive data driven decisions across the organization.
Must have extensive experience managing cross-functional matrix teams and continuous improvement initiatives. Lean six-sigma experience preferred.
Must be skilled in strategic thinking, managing through systems, innovation management, and negotiation. Must possess a strategic perspective, leading vision and values, and leadership disposition.
DUTIES AND RESPONSIBILITIES
Serve as member of the Global Manufacturing Leadership Team.
Lead Global Manufacturing through the introduction and development of new technologies for cell therapy manufacturing optimization and competitive advantages.
Promote Patient Focused Culture that strives to be a high performing team that delivers right first-time results.
Establishes, communicates, and ensures execution of the overall strategy and vision for the site including Manufacturing (Logistics, Media Prep, Operations, Compliance), Supply Chain (Warehouse, Production Scheduling, Master Data Management, Material Handling, Site Procurement), MS&T (Floor Support, Automation/MES, Process Eng./Tech Transfer), Business Operations (PMO, OPEX, Office Management), F&E and EHS. Matrix manage Quality Assurance, Quality Control, IT, HR, and Finance.
Ensures operational functions operate efficiently and reliably to ensure product supply meets on-time clinical demand within established specifications.
Develop and manage the 3-year site operation plan and annual operational budget.
Develop strategy and implement plan for continuous improvement projects to develop site into a best in class, multi-product facility.
Serve as Warren manufacturing strategy lead at JPT and JSC governance meetings with external business partners.
Ensure that all products manufactured at the site are produced and tested in compliance with regulatory filings, SOPs, cGMPs and global regulations. Ensures systems, resources, and action plans are reviewed and decisions made to attain sustainable compliance.
Collaborate with process development and analytical development groups to best understand product attributes, process and assay characteristics, while effectively interpreting and applying regulatory guidance, to propose practical solutions and methods to address complex challenges.
Champions and directs initiatives that accomplish continuous improvement and cost effectiveness and enhance efficiencies and compliance of processes and procedures.
Sets site goals and objectives, determine policy and strategic direction, establishes and oversees operational budgets.
Ensures close coordination and collaboration between site functions and process development, analytical development, pre-clinical, clinical research, clinical operations, regulatory, patient operations and commercial operations, to ensure alignment with team goals, and optimization of the supply chain.
Oversees operational functions of human resources including determining the strategic staffing plan, interviewing and selection, onboarding, organizational development, managing resources, mentoring, coaching, counseling, performance management and compensation.
Ensures all direct report staff are trained in cGMPs, SOPs, company policies, safety and meet the applicable qualification requirements.
Ensures appropriate levels of raw materials and supplies are ordered, inventoried, warehoused, and distributed to ensure consistent manufacturing and testing of products produced at the site.
Ensures electronic systems are implemented, validated, and maintained to support all aspects of material management, warehousing, manufacturing, testing, and distribution.
Foster a well-trained, motivated and informed staff.
Build a high performing, world-class team/workforce that is elite, agile, and resilient to deliver novel manufacturing processes and lean/optimized way of performing manufacturing work.
Reviews and assures adequacy of site staffing, skills, and headcount to support manufacturing and testing needs and maintain compliance with cGMP requirements.
Regularly communicates a vision, provide business updates and provide the proper framework for individual and functional goals.
Ensures all unit staff receive training in cGMP’s SOP’s, Company Policies and safety, and that employees meet defined qualification requirements for the position to which they are assigned.
EDUCATION AND EXPERIENCE
Bachelor’s Degree and Master’s Degree in a scientific discipline with at least 20 years previous experience in GMP operations in the pharmaceutical industry.
Management of cross-functional teams with 15 years of managerial experience.
High degree of organizational skills with strict attention to detail.
Ability to communicate effectively and function cooperatively with all levels of organization and external parties.
Ability to strategize, recognize the need for and drive improvements.
Expert understanding of and ability to implement cGMPs, licensing and certification requirements.
Knowledge of current regulations governing cell therapy related cGMPs and the ability to apply them in a development phase appropriate manner to the relevant manufacturing and quality areas.
General computer skills; Minitab, Microsoft (Excel, Word, PowerPoint, Project), Visio
Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated, but may require standing and walking for up to 10% of the time. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.
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.