Senior/ Principal Scientist, BDCC API

在 Johnson & Johnson，我们相信健康就是一切。 我们在医疗创新方面的实力使我们能够建立一个能够预防，治疗和治愈复杂疾病的世界,在这个世界中,治疗更智能，侵入性更低,并且解决方案是个性化的。 凭借我们在创新医学和医疗技术方面的专业知识,我们处于独特的地位,能够在当今的全套医疗保健解决方案中进行创新,以实现未来的突破,并对人类的健康产生深远的影响。 如需了解更多信息，请访问jnj.com

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工作职能：Discovery & Pre-Clinical/Clinical Development

作业子功能：Biotherapeutics R&D

职位类别：Scientific/Technology

所有职位发布位置：Shanghai, China

职位描述：
Senior/Principal Scientist, BDCC API

Description

We are seeking highly motivated Scientists to join Biologics Development China Core API group. The position offered will be based on candidates' experience level. The candidate will function independently and efficiently as a process development expert and actively engaged in process and drug substance development within a cross-functional team. He/she will conduct/lead biologics API related activities, such as early- and late-stage process development, technology transfer, and GMP manufacture support covering antibody, ADC and other bio-conjugates. He/she should possess strong technical knowledge, initiative and scientific dedication, and make significant scientific and technical contributions within process development team.

Roles & Responsibilities

Lead biologics early-stage DS process development including upstream, downstream, and bio-conjugation processes in collaboration with CDMO

Familiar with late-stage process development and tech transfer to GMP facilities

Review and provide technical oversight of GMP manufacturing processes, batch records, process characterization, deviation, CAPA and change control

Collaborate with cross-functional teams including BDCC and Protein API/DPD/AD, Quality, RA, and CSC teams as appropriate.

Provide input on the evaluations of CDMO or external partners.

Qualifications

PhD, MS, or equivalent degree in biology, chemistry, biotechnology, or a related field. A minimum of PhD with 5+ years, or MS with 10+ years related biopharmaceutical industry related experience.

Hands-on experience with cell culture, bioreactor, purification, or bio-conjugation processes development for biologics or ADC.

Solid understanding in process optimization, scale-down, scale-up, and technology transfer to GMP manufacturing facilities.

Experience managing external manufacturing CDMOs, and good communication and project management skills to work in a multidisciplinary team to meet timelines.

Proficient in English and Chinese.

This position is based in Shanghai and may require up to 10% domestic or international travel.

Required Skills:

Preferred Skills: