Specialist for Sterile Drug Product Manufacturing & Process Validation (Launch Expert PLaNTS) (m/w/d)
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The PlaNTS (Parenteral Launches and New Technologies Stream) Organization at Kaiseraugst is ensuring timely implementation of new technologies, realization of Capex projects and coordination of Product Launches and Technical Transfers. Our expertise, open mindset and passion for continuous improvement is the foundation to bring innovation to life. As part of PLaNTS, the Launch Experts Team contribute to this mission as experts with a wide range of cross-functional focus areas such as Drug Product validation, local packaging development, manufacturing of sterile and combination products.
The open Launch Expert position is related to this last mentioned field of expertise: sterile manufacturing of Drug Products and Combination Products, including associated activities, such as validations of product related production processes or assessments of technical upgrades or changes. This includes supporting products during launches and technical transfers, as well as commercial manufacturing as a subject matter expert (SME).
Conduct validation of product related production processes for sterile drug products as part of different technical transfer teams.
Develop and improve local as well as global validation strategies for sterile products, combination products and devices and take care of additional product aspects such as Leachables/Extractables, Filter Validation etc. in close collaboration with the local and global stakeholders like different value streams in Kaiseraugst, other production sites, different development teams and global functions in the Roche/Genentech network.
Strive for innovation, significant improvement and reduction of process time. Evaluate scenarios to reduce costs and establish lean and robust processes.
Support the manufacturing Value Streams as a subject matter expert, including troubleshooting, continuous improvement and quality risk management. Bring local perspective related to technical feasibility, implementation options or validation strategies into cross- functional and cross-site projects, eg related to roll out of new technologies or definition of global standards.
Manage the lifecycle of validation processes and validated products, author relevant regulatory dossier sections and support regulatory strategies and their implementation.
Role model agile mindset, in partnership with key stakeholders, play a pivotal role in evolving our manufacturing and validation processes to apply agile principles and technology advances and leverage LPS methodology
Ability to work self motivated and effectively in a self-organized, multi-disciplinary team in an agile environment.
Strong communication and collaboration skills with various stakeholders, a strategic and solution-oriented mindset, compliance focus, and a can-do attitude.
Multiple years of relevant experience in the bio/pharmaceutical industry, ideally in manufacturing, process validation, or technical development.
Fundamental understanding of processes and control strategies for sterile or combination product manufacturing and assembly, along with knowledge of safety, quality, and regulatory requirements including cGMPs.
A BS/BA degree in life sciences, engineering, or an equivalent combination of education and work experience, along with fluency in German and English. A track record of driving change while balancing risks and ensuring successful outcomes.
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Roche Kaiseraugst is a cornerstone of Roche's global production and logistics network. It employs some 1900 people out of the 10,700 employees at our Basel/Kaiseraugst site and is Roche's largest and most innovative packaging facility worldwide. Read more.
Besides extensive development and training opportunities, we offer flexible working options, 18 weeks of maternity leave and 10 weeks of gender independent partnership leave. Our employees also benefit from multiple services on site such as child-care facilities, medical services, restaurants and cafeterias, as well as various employee events.
We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche.
Roche is an Equal Opportunity Employer.
