Senior Scientist – Cell Culture Lead Full-time

Senior Scientist Of Biologics CMC

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China Innovation Center of Roche is seeking a talented and experienced Senior/Principal Scientist in Biologics CMC group for developing cell line development and cell culture strategy and driving execution of strategies to support biologics discovery and development programs. The final position offered depends on the experience level of the candidate. The successful candidate will work with dynamic and highly motivated teams to drive the discovery and development of antibody therapeutics for unmet medical needs. The position requires effective collaboration on multidisciplinary teams with members from multiple functions of CICoR, and interfaces with Discovery, CMC, Pharma Technical Development (PTD), Quality, Regulatory and external CRO/CDMO partners.

Responsibilities include:

• Develop cell line development and cell culture process development strategy as a part of overall project technical development strategy to support IND and early clinical development
• Drive cell line development and cell culture process development activities in collaboration with Roche TDTs and Roche qualified CDMO partners, including development and scale-up of mammalian cell culture and harvest process, from seed train to bioreactor harvest for production of biologics, lead clone selection, and process optimization. Author, review and/or approve technical reports for documenting process development activities
• Support technology transfer of manufacturing processes from biotech partners to Roche or a Roche CDMO partner, or from one Roche site/CDMO partner to another Roche site/CDMO partner
• Ensure cGMP compliance with ICH guidelines and regulatory requirements
• Serve as a CLD and CCPD technical SME on biologics technical development teams, CMC due diligence teams and CDMO assessment/qualification teams
• Drive transient CHO expression and purification to support discovery and preclinical projects in collaboration with Discovery teams
• Close communication and collaboration with Discovery, CMC, Quality, Technical Regulatory and PTD to ensure alignment and E2E mindset
• Participate in due diligence to evaluate external opportunities for in-licensing of assets or technologies
• May serve as CMC lead that designs and executes project CMC development strategies and risk mitigation strategies, drives planning and operational excellence of early development CMC projects, manages seamless collaboration with CMC-related functions to deliver biologics CMC projects

Candidate profile includes:

• Ph.D. in Biology, Protein Chemistry, Analytical Chemistry, Biochemical Engineering or related field, including at least 5 years of recent CLD and/or CCPD experience preferably in a biotech or pharma setting, or a MS in above areas with at least 8 years of relevant experience. A track record of effective support in drug discovery and development programs.
• Hands-on experience in bioreactors for biopharmaceutical/biologic production, experience in leading mammalian cell culture process development activities
• Understanding of cell biology and metabolism. Experience in clone selection, cell line development, cell line characterization, cell line stability study and related technologies
• Experience in cell culture media development, evaluating and implementing novel process and analytical technologies, and experimental design and data analysis using statistical methods and software
• Experience in technology transfer and scale-up of cell culture process
• Understanding of cGMP and biopharmaceutical product development lifecycle, and in regulatory filings (BLA, MAA, IND)
• Excellent skills for problem solving and deviation/OS investigation
• Demonstrated ability to quickly learn new techniques/skills and to have a sustained record of productivity
• Excellent collaboration, communication and time management skills with a deep commitment to team goals as well as successfully driving multiple efforts based on priority
• Familiarity with pharmacopoeia (USP, EP, BP) is a plus
• Experience in adjusting N-glycosylation, acidic, and basic components is preferred.

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