For Pharmaceutical Sciences (PS) at the Roche Innovation Centre Shanghai (RICS), we are looking for a Bioanalytical Manager (BAM) that is part of the Global Bioanalytical R&D department. This position provides bioanalytical scientific and operational expertise to non-clinical and clinical study teams to implement and execute strategies for pharmacokinetic (PK) and immunogenicity analysis. The BAM serves as a single point of contact between global scientific functions and Contract Research Organisations (CROs) assay transfer from internal assay development labs, troubleshooting, potentially external assay development at CROs, execute bioanalysis, and facilitate timely delivery of data to internal stakeholders and project teams. Besides a strong integration into the RICS site, the BAM has a close relationship to small molecule and large molecule BAM colleagues and with the Bioanalytical (BA) Sciences groups at the Roche Innovation Center Basel (RICB) and Roche Innovation Center Munich (RICM).
- Works with large molecule project teams to understand program development direction and deliverable requirements for program decisions and regulatory filings to ensure program needs are met with timely data delivery
- Develops and maintains effective, collaborative relationships with study teams, scientific function key stakeholders, data groups, internal outsourcing contacts, and preferred CROs.
- Analytical support for non-clinical and clinical studies including assay development and validation.
- Facilitate technical problem solving, trouble shooting.
- Authors or reviews bioanalytical data and all study related documents (i.e. Protocols, Lab Manual, ICF, ,...).
- Posting of final Bioanalytical Reports and validation reports into the relevant databases, documents and folders.
- Scouting and identification of appropriate CROs for the determination of the required analyte(s) for PS global outsourcing strategy (expertise, technology, free capacities etc.). Manage CRO deliverables and performance. Reviews data generated at CROs and internal lab.
- Manages all communication with the external BA labs
- Ensures strong interaction with all members of the Bioanalytical R&D organization (project- specific, technologies, general strategies, etc) and attends all relevant meetings and discussions; yearly visits to Europe for the key Scientific Department Meeting.
- Ensures relevant regulatory compliance and internal business standards and follows changes and developments in the regulatory environment; is aware of Chinese (cFDA) and global (FDA, EMA) guidelines and contributes to commenting of new guidelines.
- Ensures compliance and understanding of HGRAC policies.
- Expand scientific visibility and maintain effective interactions with internal and external collaborators.
- Contribute to scientific advancements in the BA field.
- Development of junior scientists in BA and related areas (such as Biomarker). Knowledgeable on specific Chinese regulatory requirements (HGRAC, tissue distribution, translation requirements, etc…) mentors the global BAM community on Chinese aspects of BA regulations.
Qualification and Experience:
- A Ph.D., or equivalent degree plus experience, in analytical chemistry or other relevant bio-medical science discipline.
- Solid knowledge of operations and science in large molecule BA. In-depth understanding of modern approaches in BA to support drug development with >5 years working experience in pharma/biotech/CROs
- Highly self-motivated and innovative mindset in new BA and related areas
- Open and honest collaborations with internal and external partners (for example global colleagues, CROs, universities and research institutes, amongst other institutions)
- Good organizational and multi-tasking abilities to ensure quality and timely delivery of data.
- Excellent communication skills (English and Chinese),
- Strong interpersonal skills and excellent team player.
- Practical knowledge of ELISA and hELISA methods and LC-MS in Large molecules is a plus.
What we offer:
- Roche is committed to RICS, hence this is a great opportunity to join an expanding team offering opportunities for personal growth while enjoying job security in a prestigious leading organization.
- Travel is not compulsory, however there would be the possibility to work in close collaboration, and visit regularly on a business need basis, RICB (Switzerland) and RICM (Germany).
- Publications and oral presentations (both internal and external), on a relevant business need, are encouraged and supported.
- Training will be provided to cover any gaps in otherwise exceptional candidates, hence this role provides great development opportunity.