Senior/ Principal Scientist, BDCC API Full-time

Senior/Principal Scientist, BDCC API

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.