Job Description

Summary Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally.Join us as a Founder of our xe2x80x98newxe2x80x99 Sandoz!Job Purpose:Represents the main technical interface for Sandoz Manufacturing sites and external suppliers by providing technical expertise on manufacturing and packaging process design, process- and cleaning-validation and resolution of technical issues. Applies an appropriate level of product and process oversight to ensure product quality and process robustness. Ensures availability of all Technical Documentation involved in the above process.Supports the ESO Technical Managers in performing the technical due diligences in pre-evaluation phase to select the appropriate external suppliers together with BD&L. Support in the documentation involved in this process.
Acts as responsible Technical Expert to facilitate Product Transfers for legacy products as well as new development products from Sandoz Development to different Manufacturing sites and from Sandoz to external suppliers or between external suppliers. Aligns with the Development organization for manufacturing process design during early stage development. Support in the documentation involved in this process. Provides technical / scientific process support to respective Supply relationship teams (SRT) and works in close relation with other SRT members (QA Managers, Site Change Coordinators, Supply relationship Manager etc.) for evaluation of technical compliance activities (Deviations, Change controls, Customer Complaints, CAPAs). Ensures seamless flow of knowledge and information transfer within the organization and across functions with focus on process and product know-how.Your Key Responsibilities:Your responsibilities include, but not limited to:Technical Support to internal Manufacturing Sites and CMOxe2x80x99s:As a Technical Expert to the assigned manufacturing site internally or CMO, ensure and improve product process capability, to keep the knowledge of process up to date and to maintain the product in constant state of validation.Implement Science- and Risk-based approaches to ensure that product quality can be sustainably reproduced.Ensure the availability of all relevant Technical Documentation such as protocols, reports, Risk Assessments, Concept papers, Scientific Justifications based on significant body of information generated regarding the product & the process ahead of the planned activities at the respective sitesProduct/Technical Stewardship for assigned sites:Act as Technical Expert to maintain the oversight and knowledge for entire manufacturing process throughout the entire commercial lifecycle at given internal Mfg site/ external suppliers.Ensure a proper understanding of manufacturing process and influencing factors (i.e. CQAs, CMAs and CPP) to ensure product quality and process robustness at the commercialization site.Analyze product-specific manufacturing data from OPV Reports/CPV Reports/APQRs and other relevant sources where needed and agree on state of controlAssess impact of technical changes, assess technical feasibility and determine scope / design of technical batches, challenge technical risk and business benefit of proposed technical changes.Contribute to the registration strategy and ensure alignment of (regulatory) timelines for technical changes, transfers, launches and/or major deviations.Lead / support the assigned sites on the root cause investigation of product and process failures.Effectively liaise with the CMOxe2x80x99s to initiate and lead/support product / process remediation / improvement activities, involving cross-functional teams and with clear interfaces to Quality, Operations, Engineering and Technical Development.Maintain Division and/or cross-division networks to share lessons learned and best practices related with process and technologies.Validation Support xe2x80x93 for product(s) /Sites assigned:Responsible for the validation oversight and for maintaining the product in constant state of validation.Challenge defined control strategy based on CQA and where necessary on CPP, CMA. prior to validation and for defined improvement projectsReview respective Quality Risk Analysis (QRA) prior to validation for technical changes.Ensure that technical batches generate sufficient process knowledge by thoroughly testing critical variables and use the output to verify critical process parameters.Review validation protocol and report as appropriate.Provide all necessary information to generate the validation documentation.Support Validation Lead and Experts to assess need and plan validations, assess revalidation need.Launch & Transfer Support xe2x80x93 for product(s) /Sites assigned:Participate in external supplier / product evaluation and selection process. Responsible for gathering technical information on manufacturing process capability at the site/external supplier.Provide the necessary data for the technical activities involved in Tech Transfer of a product through the appropriate documentation, focusing on existing knowledge. Support technical activities at the giving / receiving site as needed.Define product acceptance criteria for the transfer, agree on acceptable performance with receiving organization and monitor routine manufacturing performance following transferEnsure successful and well-documented transfers and launches of products with external manufacturing involvement.Active support for Product Launch and Transfer governance processesInterface to Development for the product(s) /Sites assigned:Ensure that new products and processes are well developed for the commercial scale and the entire product lifecycle at the commercialization siteProvide input to formal stage gates during development and up to first OPV/APR/PQR as part of the development process to ensure early integration and to ultimately meet manufacturing requirementsSupport development of comprehensive control strategy early on in the development to ensure that validation requirements meet regulatory requirements and other critical metrics (e.g., quality, safety, environmental, cycle times, etc.).Manufacturing & Operational Excellence xe2x80x93 for defined product(s) /Sites assigned:Define and execute design and control optimization projects where needed.Provide SME expertise to perform process characterization of pharmaceutical processes to increase robustness and sustainability.Training:Own the Training Curriculum for its and direct reports.What youxe2x80x99ll bring to the role:Minimum Requirements: xe2x80x8bEducation (minimum/desirable):Bachelors/Masters. in Pharmacy, Pharmaceutical Technology, Chemistry or equivalent scientific degree.Desirable MSc. or PhD.Languages:Fluent in English & Local Language of the respective Country.Relevant Experiences:Minimum 8 years of experience in pharmaceutical (chemical) manufacturing.Experience in a global/matrix environment in the pharmaceutical industryComprehensive know how in pharmaceutical (chemical) technologyProject Management experienceDrug Development experienceSound experience of data handling and applied statisticsYouxe2x80x99ll receive:Breakdown of benefits received in this role. Include flexible working, learning and development opportunities as well.Why Sandoz?Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!The future is ours to shape!#SandozSkills Desired Applied Statistics, Assembly Language, Change Control, Chemical Engineering, Continual Improvement Process, Cost Reduction, Data Analytics, Electronic Components, General Hse Knowledge , Including Gdp, Knowledge Of Capa, Knowledge Of Gmp, Lean Manufacturing, Manufacturing Process, Manufacturing Production, Manufacturing Technologies, Process and Cleaning Validation, Process Control, Process Simulation, Risk Management, Root Cause Analysis (RCA), Scientific Method, Six Sigma, Statistical Analysis, Technology Transfer

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