11 часов назад
Senior/Principal Scientist, BDCC API
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Senior/Principal Scientist, BDCC API (Biologics Process Development): Developing biologics drug-substance processes for antibodies, ADCs, and other bioconjugates with an accent on upstream, downstream, bio-conjugation, technology transfer, and GMP manufacturing support. Focus on optimizing and scaling processes, overseeing CDMO manufacturing activities, and solving cross-functional development and quality challenges.
Location: Shanghai, China; up to 10% domestic or international travel may be required.
Company
Johnson & Johnson MedTech develops healthcare and medical technology solutions through its MedTech and Innovative Medicine businesses.
What you will do
- Lead early-stage drug-substance process development for biologics, including upstream, downstream, and bio-conjugation processes.
- Collaborate with CDMOs on process development and evaluate external manufacturing partners.
- Support late-stage process development and technology transfer to GMP manufacturing facilities.
- Review GMP manufacturing processes, batch records, process characterization, deviations, CAPA, and change controls.
- Work with BDCC, Protein API, DPD, AD, Quality, Regulatory Affairs, and CSC teams.
Requirements
- PhD with 5+ years or MS with 10+ years of relevant biopharmaceutical industry experience.
- Degree in biology, chemistry, biotechnology, or a related field.
- Hands-on experience with cell culture, bioreactor, purification, or bio-conjugation process development for biologics or ADCs.
- Strong understanding of process optimization, scale-down, scale-up, and technology transfer to GMP facilities.
- Experience managing external manufacturing CDMOs, with strong communication and project management skills.
- Proficiency in English and Chinese is required.
Culture & Benefits
- Work in a cross-functional biologics development organization.
- Contribute to healthcare innovation across complex disease prevention and treatment.
- Collaborate with multidisciplinary internal teams and external manufacturing partners.
- Travel may include domestic and international assignments, up to 10%.
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