Celgene Global Product Steward in Phoenix, Arizona
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.
MS&T is a science-driven organization dedicated to building in-depth and comprehensive knowledge of our products and their processes. We work across the entire lifecycle of our Pharmaceutical Products and across both internal and external manufacturing and API Manufacturing.
The business model in the Pharmaceutical Industry is undergoing significant changes. In addition to commercial pressure, pipeline shortfalls, personalized medicine, product complexity and political challenges, there has been a major shift in the technical requirements of regulatory agencies. These agencies now expect Industry to develop a more fundamental understanding of manufacturing science and process control and relate this to clinical risk.
Global Supply and MS&T through the introduction of Global Product Stewards, will augment and strengthen its technical capability, actively manage CMC for the commercial portfolio, improve process understanding and control to mitigate regulatory risks on existing products and avoid delay to product launches from regulatory scrutiny or manufacturing issues.
The Global Product Steward has technical accountability for a defined portfolio of commercial and new products, the manufacturing process(es) and quality aspects (Chemistry, Manufacturing & Controls), end to end throughout the Supply Chain and across multiple sites. A key element of this role is risk management (technical, quality, regulatory, supply etc). The GPS is responsible for maintaining and improving product process understanding (knowledge), capability, quality, compliance and cost. Responsible for the development and execution of a Product Technical Life Cycle strategy which is consistent with future regulatory expectations and the commercial ambition for the products. Represents MS&T within the Global Commercial Supply organization and the wider Celgene organization.
Responsibilities will include, but are not limited to the following:
Manages the CMC for the products portfolio. Owns the manufacturing process for product(s) made at one or multiple sites (standardize across sites). Maintains an overview of the product(s) process performance across multiple sites and the value chain, through data trending and CPV, analysis of customer complaints, from raw materials to finished pack, to ensure process(es) are in control and robust.
Works with Development and takes accountability for the technical acceptance of reliable manufacturing processes from Development into Global Supply.
Defines a technical lifecycle strategy targeted at risk reduction, product robustness and cost reduction consistent with manufacturing and marketing plans (commercial ambition). Leads the execution of this improvement strategy.
Ensures products’ processes are in constant state of validation end to end, across multiple sites (plays a key role in APR’s, technology transfers and regulatory submissions).
The primary contact/leader person for complex technical problems, in which multiple sites may be implicated. Leads interdisciplinary/global teams for investigations that are common across sites or those that are cross functional. Liaises with other functions (e.g. Development, QA, Regulatory) to ensure complete and concise root cause investigation and resolution. Supports sites during regulatory inspections, provides technical answers to regulatory inspection bodies or Health Authorities.
Drives innovation in the manufacturing and analytical processes (eg. new technologies, continuous manufacturing, Process Analytical technologies). Maintains contact with external innovators, universities, regulatory bodies to understand the external environment.
Develops, implements and applies knowledge and risk based approaches, including Quality by Design, state of the art process understanding and Process Analytical Technologies.
Keeps oversight of Technical Change management to ensure consistency across value chain. Ensures timely evaluation and implementation of changes.
Initiates and oversees process improvements projects (for quality improvement & cost reduction), proactively interfacing with the relevant functions involved (e.g. Production, Supply Chain, Engineering, QA, IT, Regulatory, Development etc).
Advises on Scientific and Business developments (including Technology, Processes, Products, Regulations etc). Support Due Diligence activities related to the Product. Coaches and shares knowledge with local site experts and manufacturing staff.
Responsible for expanding and continuously updating a scientific knowledgebase for the Therapeutic Area products. Actively seeks ways to manage and share knowledge across Global Supply and R&D.
Formally reviews performance of Products with responsible Site Experts/contacts and QA.
Assist with the development of Standards, Guidelines and SOP’s to enhance the quality and robustness of our manufacturing operations, knowledge transfer and technical support processes.
Master Degree in Engineering, Chemistry, Biochemistry/Pharmacy or natural science.
At least 15 years of experience in Pharmaceutical/Biotechnology Development or Production.
Experience of both Primary (API) and Secondary Manufacturing (Drug Product).
Excellent working knowledge of QA, cGMP and the Pharmaceutical Regulatory framework.
Excellent technical/scientific skills and knowledge, demonstrated by in-depth scientific understanding of pharmaceutical products or processes
Extensive knowledge of QbD.
Excellent leadership skills and ability to influence and work across organizational boundaries.
Tactical and practical negotiation sand good communication skills.
Project and change management experience. Experience with Product Life Cycle Management.
Excellent command of English and preferably another European language.
Self-starter, team player, effective leader and keen on working in a cross-cultural working environment.
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.