Head of Locked Nucleic Acids (LNA) Technical Development
Behind every presentation of each product sold by Roche is the involvement of Pharma Global Technical Operations (PT). Starting with Phase I of the development process and continuing through to product maturity, PT makes medicines at sites around the world and includes more than 10 000 employees worldwide.
"Global Technical Development" (PTD) actively collaborates and develops innovative technical solutions to efficiently transform scientific ideas into products. The mandate of the group is, to reliably deliver the pipeline and supply quality products to patients. The group excels in its work through innovation, collaboration, dedication, and mutual respect and adds value every day, continuously improving what it does.
Locked Nucleic Acids/Oligonucleotides, is a new molecular format that Roche is developing to treat diverse diseases. We in PTD are responsible for the technical development of LNAs through clinical phases leading to market approval. This includes Drug Substance and Drug Product process development and manufacturing, formulation, the establishment of a control strategy and the transfer to commercial sites.
As the Head of LNA Technical Development you will be coordinating all development activities and ensuring a path to successful approval of this new molecular format at Roche. This will include working with the Small Molecule organization (PTDC) to oversee the development of chemical synthesis and analytics while coordinating formulation development in the large molecule organization (PTDE) and liaising with microbiological experts.
Your key responsibilities are:
Coordinate a flexible Network of LNA Subject Matter Experts at PTD, develop a long-term Strategy of LNA Technical Development including infrastructure investment needed externally and/or internally
Partner with Research and Commercial organizations to ensure end-to-end view of LNA development to ensure robust control strategy and reliable supply to patients
Coordinate all LNA Technical Development activities in the fields of Drug Substance Process development, Analytical R&D, Formulation Development, Microbiological Testing, CMO Technical Oversight and keep Science and Technology expertise at the latest state of the art
Lead a portfolio of LNA projects from Phase 1 to Launch by providing good scientific judgment to decision-making and problem solving
Support Roche`s LNA regulatory submissions by applying the principles of Quality by Design to drug development and corresponding documentation
Lead and develop colleagues within various organizations according to Roche Leadership Commitments, demonstrating PT Behaviors and encouraging highly motivated teams to achieve courageous goals hence demonstrating the Roche leadership principles in everything you do and say
Be an active Member of the PTDC Leadership Team, contribute to the PTDC strategy and adapt to changing environmental conditions while maintaining a productive and constructive relationship with a wide variety of partners within PTD network and beyond
Be an active promoter and role model for a flexible and open mindset, embracing new opportunities and encouraging change
Your Profile:
You have a PhD or Master Degree in scientific discipline and at least 10 years industry experience as a leader in pharma/biopharma business with experience in development of Oligonucleotides (LNA, siRNA, ASO).
For this position you bring the following qualifications:
Deep understanding of CMC drug development and regulatory submission generation and health authority expectations, especially for Oligonucleotides
Excellent, authentic leadership skills with the shown ability to guide and motivate both a leadership team as well as a diverse workforce
Strong ability to make decisions and assess risks
Change agent with focus on collaboration high-level influencing, interpersonal and negotiation skills as well as a will to build and maintain constructive and effective relationships with team members as well as internal and external stakeholders
Fluent communication level in English and ideally also German