The Roche R&D Center (China) Ltd (pRED China) was established in 2004, pioneering pharmaceutical R&D in China, and is located in the Zhangjiang Hi-Tech Park in Shanghai. The pRED China, also recognized as Roche Innovation Center Shanghai (RICS), is a fully integrated organization from discovery to early clinical development, and currently has about 150 scientists.
Over the years, the center has made many contributions to Roche’s innovation in healthcare by doing what patients need next. Drug candidates jointly developed with global or independently developed at pRED China have entered into GLP toxicological testing or clinical trials in multiple disease areas. With the strong support from Roche headquarter; the center has earned the respect from peer companies and local government authorities as a biopharma innovation leader in China.
The center has fully evolved into an integral part of Roche pharma Research and Early Development organization (pRED). The center’s objectives are primarily aligned with global Roche pRED disease therapeutic area (DTA) strategy of discovering and developing differentiated medicines for infectious, immunological, and inflammation diseases. Virology, especially HBV, is the major focus for pRED China. Besides internal organizations, pRED China collaborates with many renowned external academic institutes, biotech companies and contract research organizations within and outside of China, as well as with China FDA. We will continue to establish and maintain a broad alliance network locally and globally to drive the drug development and translational medical sciences activities in China.
The preclinical CMC (pCMC) is part of Therapeutic Modalities (TMo) within pRED. We deliver leading edge science to drive the success of Roche’s portfolio from optimal clinical candidate selection to clinical studies through strong expertise in drug substance and drug product development. The pCMC Shanghai Head position reports into pCMC Global Head, Basel, Switzerland.
Roles and Responsibilities:
- Lead and manage pCMC organization in pRED China.
- Manage allocated budget.
- Ensure development and supply of Active Pharmaceutical Ingredient (API) and Drug Product (DP) for pRED portfolio projects in a fast and compliant way (SHE& GLP) for toxicological studies according to overall CMC strategy.
- Support mentoring and career development of all staff, including national and international exchange programs to share knowledge and expertise between centers in close collaboration with the human resource department.
- Ensure implementation of global pCMC strategy in China.
- Ensure the development of new methodologies and build up/maintain state-of-the art capabilities and knowledge in chemical synthesis, process research, pharmaceutical profiling, formulation, and analytical sciences by tracking scientific and technical trends and opportunities.
- Ensure adherence to local and global regulatory standards, and lead interactions with China FDA for CMC related topics.
- Ensure optimal use of CRO/CMO. Support Drug Discovery in the selection of clinical candidates.
- Partner closely with the discovery teams and management in design of optimal and innovative strategies for clinical candidate selection and preclinical studies. Manage resources for optimal support of projects in coordination with local and global management functions.
- Implement and maintain effective and efficient interfaces with relevant stakeholders (local and global) in Roche, including with early and late stage CMC functions. Work with Head of pRED China to develop business plans. Represent pCMC in China Management meetings.
- Serve as a member of China Management Team (CMT) and contribute to pRED China portfolio development, and continuously optimize business processes.
- Serve as a member of Small Molecule Discussion Forum (SMDF), and when required on other decision-making bodies.
- Ph.D. in chemistry or pharmacy.
- > 15 years of scientific and managerial experience in Chemical R&D or Pharmaceutical R&D (Process Research, API supply, preformulation, formulation development and supply, analytical sciences or related area).
- Early discovery, preclinical and clinical development experience from CMC perspective is strongly desired.
- Leadership experience in establishing a strong partnership with discovery and development functions is required. Leadership experience preferred in coaching and developing a multi-disciplinary team and department.
- Strong communication skills and capability required to build a highly productive and collaborative team. Able to speak and write effectively both in English & Chinese.
- Outstanding hands on track record preferred in driving negotiations with both internal and external stakeholders. Experience in interacting with regulatory agencies is an add on.