Inga Schuster
Director Sterile Production at Takeda in Deutschland- Claim this Profile
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German Native or bilingual proficiency
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English Full professional proficiency
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Bio
Credentials
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Strategisches Denken und Handeln für Führungskräfte
LinkedInOct, 2020- Oct, 2024
Experience
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Takeda in Deutschland
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Germany
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Pharmaceutical Manufacturing
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300 - 400 Employee
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Director Sterile Production
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Feb 2021 - Present
Lead of the sterile and compounding production department with > 160 employees and member of the site leadership teamTechnologies:- Lyophilization - Liquid vial filling- Blow/fill/seal of sterile and non-sterile products- Compounding of non-sterile products (suspensions, creams, liquids)Member of the Site Leadership Team Lead of the sterile and compounding production department with > 160 employees and member of the site leadership teamTechnologies:- Lyophilization - Liquid vial filling- Blow/fill/seal of sterile and non-sterile products- Compounding of non-sterile products (suspensions, creams, liquids)Member of the Site Leadership Team
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Roche
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Switzerland
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Biotechnology Research
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700 & Above Employee
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Head Packaging
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Mar 2017 - Feb 2021
Lead of the Packaging Department (in total appr. 320 FTE) and member of the Kaiseraugst leadership team- Packaging of solid and sterile drug products- Technologies: Solids in blister and bottles, steriles incl. assembly (prefilled syringes in safety devices and autoinjectors)Main activities- Applying strong change management with positive impact on departmental performance. Fostering agile ways of working with self-directed teams. - Establishing small volume packaging concept and set-up assuring agile packaging of small orders with high impact on flexible supply and assuring excellent launch performance- Strong contribution to successful lead time reduction of finished goods by improvements in change over times, release activities, and line concepts- Pilot plant for introduction of lean production system (LPS), intense progress in standardization, continuous improvement of processes and lean leadership, focusing on business goals- Passionate leader with focus on development of employees and their skills by intense support in perspective changes, temporary assignments, advanced vocational training, and training of apprentices with strong impact on career steps and employability of the work force. Development of talents into department and site key functions.- Actively striving for personal development in creative leadership skills, acting as servant leader, preparing for evolutionary organization- Engaged driver of collaboration with development organization (device development, packaging development), operations network, supply chain organization, and technical product management ensuring best solutions for E2E processes and smooth transfers
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Head Business Support Sterile Manufacturing
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Apr 2014 - Feb 2017
Support of the site head and the site leadership team in operational and project related activities. Coordination of budget process, target setting, KPI reporting structure. Main contact between site and technical product management. Representation of safety, health, and environment (SHE) and facility management activities on site. Responsibility of operations support for sterile manufacturing. Focus on capacity planning of visual inspection, reduction of overall cycle times by improving efficiency of make - assess - release activities, implementation of semi-automated visual inspection. Responsible for communication with Chugai Pharmaceutical Co. Ltd. and sterile manufacturing site Kaiseraugst, member of "Technical Kaizen Group".
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GP Grenzach Produktions GmbH
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Germany
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IT Services and IT Consulting
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1 - 100 Employee
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Head of Aseptic Processing
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Jan 2010 - Mar 2014
Responsible for aseptic filling plant (appr. 100 employees) with aseptic filling, visual inspection, and packaging of pre-filled syringes and vials, organized in value stream set-up. Member of the local management board. High service levels in an increasing business for several customers. Managing supply, contractual, and quality relationships with customers/ business partners. Establishing new customer relations. Successful project lead for various product transfers, e.g. protein drugs. Coordinating cross-functional teams. Design, selection, installation, qualification, and validation of two new syringe filling lines and fully automated visual inspection machine for syringes.
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Head of Quality Management
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Nov 2007 - Dec 2009
Leading quality control departments (chemical/ physical and microbiological labs, lab for testing of packaging materials) and quality assurance department (including Qualified Persons for release activities), leadership responsibility (overall 65 employees). Member of the local management board. Managing quality operations for pharmaceutical and cosmetic products, as well as for medical devices. Supervising successful projects, e.g. introduction of SAP Quality module, design of new cleanroom class concept.
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Bayer
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Chemical Manufacturing
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700 & Above Employee
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Plant Manager Visual Inspection and Packaging
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Jan 2003 - Oct 2007
Responsible for the visual inspection and packaging in the parenteral production plant. Leadership responsibility, appr. 35 employees.
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GMP Manager
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Jul 1998 - Dec 2002
Responsible for qualification and validation, training activities, SOPs, preparation and support of authority inspections and customer audits for both, parenteral and ointment production facilities. 9 employees.
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Education
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1989 - 1994
ETH Zürich
Dr. Sc. nat. (Ph.D.), Pharmaceutical Technology -
1983 - 1988
Westfälische Wilhelms-Universität Münster
Pharmacist, Pharmacy
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