罗氏促进多元化、公平性和包容性，代表我们所服务的社区。在全球范围内处理医疗保健问题时，多元化是成功的关键因素。我们认为，包容性是理解人们不同医疗保健需求的关键。我们共同拥抱个性，共同抱持对卓越护理的热情。加入罗氏，每个声音都会得到重视。

职位

JOB DESCRIPTION

SENIOR/PRINCIPAL 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 biotechnology 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.

我们是谁

在罗氏，来自100个国家的100，000名员工不断推动着健康医疗行业的进步。我们一同工作，使罗氏成为了世界领先的以研发为基础的健康医疗集团。我们的成功源于创新、求知和多元化，也源于我们把相互间的差异作为一种优势。为了革新医疗健康领域，罗氏设定了远大的计划，坚持学习和发展，并不断寻找与之志同道合的伙伴。

其他信息

行业要求：全部行业
所属部门：上海创新中心