Specialist for Sterile Manufacturing Processes and Technologies (Launch Expert)

at  Roche

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.
The Position
The PlaNTs (Parenteral Launches and New Technologies Stream) Organization at the manufacturing and packaging site 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 supply to this mission with unique expertise, either in the area of Sterile Drug Product manufacturing processes and technologies or as Finished Good expert.
The position here has a strong focus on development, validation and implementation strategies for Single Use Technologies, sterile filtration systems and other key processes, supporting the commercial sterile drug product manufacturing (Kaiseraugst), as well as on coordination and timely implementation of complex global changes, locally.

EDUCATION AND EXPERIENCE

• Minimum of 5 years of relevant bio/pharmaceutical experience
• A BS/BA degree in life sciences, engineering, or an equivalent combination of education and work experience
• Successful project management and execution
• Good communications skills in English and German

REQUIREMENTS/QUALIFICATIONS

• Strong expertise in sterile manufacturing processes (preferably drug product manufacturing) and product validations
• Strong business sense and strong enterprise mentality
• Excellent understanding of manufacturing environments and quality systems and application of current Good Manufacturing Practices (cGMPs)
• Good skills in Veeva, especially in change management
• High ability to lead matrix teams and easily cooperate with different functions and other (Roche) sites
• Experience with building networks and collaborating stakeholders across hierarchical levels.
• Role model agile mindset, in partnership with key stakeholders, support evolving our change processes to apply agile principles and technology advances and leverage LPS methodology
  Who we are
  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.

• act as local expert for new technologies and related qualification and validation strategies (Single Use Technologies, including Leachables and Extractable, sterile filtration or other key processes)
• coordinate, support or drive feasibility studies and evaluations
• Perform facility fit studies for new drug product manufacturing processes and Launches
• Proof-of-Concept studies for new systems and processes
• Collect required data for decision making (Business case, timelines, risks and opportunities, etc)
• support, drive or coordinate implementation of new technologies and processes in the commercial sterile manufacturing plants (Kaiseraugst).
• act as local SPOC for global initiatives related to new sterile manufacturing technologies and processes and represent Kaiseraugst in the network
• coordinate complex global changes locally, connect to all relevant functions, assign and lead all aspects of required actions
• connect the global functions and teams with local experts and enable the successful change implementation In Kaiseraugst
• act as local SPOC who coordinates and assigns required actions locally
• ensure transparency and proactive communication to local and global partners
• Be in charge of change control oversight for local actions and task