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JOB DESCRIPTION
SENIOR SCIENTIST OF Biologics CMC
at China Innovation Center of Roche (CICoR)
POSITION
At Roche, over 90,000 colleagues are working together and doing what patients need next. Our ambition is to deliver novel therapeutics, diagnostic solutions and insights to patients with game changing clinical benefits. 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
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
Qualification and experience
The candidate qualifications include a 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.
Competencies
The ideal candidate will have demonstrated competence in the following areas:
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.
A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
Roche is an Equal Opportunity Employer.