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Other Locations:Switzerland- Boudry
DescriptionCelgene 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.POSITIONHead, Global Manufacturing Science & Technology SUPERVISORCVP, Global Commercial SupplyDEPARTMENTGPDO - Global Supply and ManufacturingLOCATION Boudry or CouvetPREREQUISITESExtensive experience in pharmaceutical manufacturingGlobal Head of MS&T is the care taker and continuous improvement function for the body of technical knowledge owned by Celgene's Global Commercial Supply function. It includes how we manufacture our products and transmitting that knowledge into manufacturing instructions. In direct collaboration with Manufacturing Operations Services and other functions like Engineering, Facilities, IT, this role provides clear directions and necessary support to:Ensure the robustness of the manufacturing and packaging processes so that all internal sites and external CSPs products are validated and remain in constant state of validation through the product lifecycle
Support and were appropriate lead optimization of pharmaceutical processes by applying sound scientific reasoning (first principles) and following integrated process and technologies strategies.
Identify and continuously apply best practices specifically in validation, training and process changes and handling of discrepancy and investigations resolution
Scope: Global ResponsibilityResponsibilities will include, but are not limited to, the following:Member of the Global Commercial Supply Leadership team (GSLT) and expected to play a full part in driving continuous improvements and supporting strategic developments
Ensure that the technical competencies and knowledge for the Global Commercial Supply sites in DS, DP and Packaging both internal and external CSPs are all in place (as applicable).
Functional ownership of global MS&T, lead and motivate team, institute development plans, address forward looking resource plans to adequately meet the needs of the site's product portfolio and strategy
Advises, guides and coaches MS&T associates for the purpose of ensuring routine operational support, identifying solutions and improvement, solving problems and decision making
Owns and promotes robust end-to-end product stewardship, ensuring single point of contact for products within the site and across sites for multi-site products. Assesses APRs/ PQRs.
Owns the overall Validation Master Plan and coordinates all related activities
Ensures adherence to cGMP requirements, Guidelines, SOPs, as well as compliance to local laws, Celgene policies and Environment Health & Safety (EH&S) requirements. Particular attention is to given to the protection of employees, patients, company assets and the environment
Promotes excellence in Packaging and Pharmaceutical Processing in the plant. Ensures that the site has set and rigorously applies appropriate technical standards for processing, packaging and materials, where applicable employing new/modern processes and technologies like Quality by Design (QbD), Design of Experiment (DOE) and Process Analytical Technologies (PAT)
Fosters proper communication and networking within the MS&T community of all related sites and integrate back into development, Pharmaceutical Science & Technology (PS&T) . Explores and maximizes opportunities to leverage existing programs (e.g. training)
Committed to knowledge sharing/transfer within/ across internal and external manufacturing sites as well as development
Develop and apply KPIs to enable meaningful CPP/CQA trending and reporting of key process data as well as to quickly identify changing quality trends and issues
Owns and actively manages the Product Improvement Portfolio (PIP) allowing for prioritization and ensuring cross-functional contribution, as necessary
Via collaboration with PS&T and other functions ensures both transfer and new product launches will be executed 'right first time' in terms of correct technology match (equipment, materials) and effective handover to the Manufacturing Operations
Responsible for the design and delivery of MS&T owned technical training programs as well as appropriate technical on-boarding to ensure proper technical competency of operations and MS&T associates for manufacturing and packaging processes
Support MS&T global staff during the execution of process improvements, scale-ups, and justification/ verification projects. Oversees that the process justification/ verification batches generate sufficient process knowledge by thoroughly testing critical variables
Develop manufacturing and packaging standards and strategies for Celgene
Stays abreast of technological, regulatory and industry developments, e.g. via internal and external benchmarking
Primary Function / Primary Goals / Objectives: CpK
Technical reports executed on time and with the right expectations
Success rate of HA's inspections
Fulfilment of Validation Master Plans
Technology transfers and new product launches on time, right first time
Weak Product resolution according to plan
General and LeadershipLeads with a global mindset and directs multiple remote teams.
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 process 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 alignment with goals, objectives and strategy. This will include KPIs for internal and external manufacturing operations.
Advocates for discipline excellence by partnering closely with internal and external stakeholders to improve customer service and develop and capture industry-competitive best practices.
Influences 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, entrepreneurial environment.
Skills/Knowledge Required:A minimum of 15 years' pharmaceutical operations experience, with at least 5 years multi-national experience. Specific experience in oral solids and sterile injectable required. Experience in Biologics desirable.
MSc. In Science, Pharmacy or Chemical Engineering, Pharmaceutical Technology or equivalent experience. Ph.D. preferred
Preferred Certified Green Belt or equivalent proficiency in applied statistics, Experience in DoE and Gage R&R
Experience in the packaging technology for pharmaceutical products
Fundamental understanding of standard pharmaceutical analytical testing
Demonstrated understanding of Q culture and regulatory regulations