about the company.
An international biotech powerhouse driving novel antibody therapies.
about the team.
Led by world-class experts with deep domain knowledge in antibody discovery and development.
...
job details
summary
- 苏州市, jiangsu
- CNY600,000 - CNY700,000 per year
- permanent
- job categorybiotechnology & pharmaceutical
job details
about the job.
show more- Lead the standardization of process characterization, establishing and maintaining best practices for study design, data analysis, and documentation to ensure consistency and quality across projects.
- Develop and implement CMC project plans based on company development strategies and project objectives, ensuring clear prioritization and focus for each project.
- Lead CMC project teams to develop timelines, manage milestones, oversee CMO activities, confirm deliverables, control project budgets, and monitor execution progress to ensure alignment with company goals and proactive risk management.
skills and experience required.
- Master’s degree or above in Pharmacy, Chemistry, Chemical Engineering, Biochemistry, or related scientific discipline. PhD preferred.
- Minimum of 8 years of relevant experience with a Master’s degree, or at least 5 years with a PhD, in CMC project management or pharmaceutical development. Proven track record in late-stage development and cross-functional team leadership is required. Experience in biologics or ADC development is a plus.
- Strong knowledge of CMC development processes, regulatory requirements (e.g., IND, BLA, NDA, IMPD), and GMP standards.
about the company.
An international biotech powerhouse driving novel antibody therapies.
about the team.
Led by world-class experts with deep domain knowledge in antibody discovery and development.
about the job.
- Lead the standardization of process characterization, establishing and maintaining best practices for study design, data analysis, and documentation to ensure consistency and quality across projects.
- Develop and implement CMC project plans based on company development strategies and project objectives, ensuring clear prioritization and focus for each project.
- Lead CMC project teams to develop timelines, manage milestones, oversee CMO activities, confirm deliverables, control project budgets, and monitor execution progress to ensure alignment with company goals and proactive risk management.
skills and experience required.
- Master’s degree or above in Pharmacy, Chemistry, Chemical Engineering, Biochemistry, or related scientific discipline. PhD preferred.
- Minimum of 8 years of relevant experience with a Master’s degree, or at least 5 years with a PhD, in CMC project management or pharmaceutical development. Proven track record in late-stage development and cross-functional team leadership is required. Experience in biologics or ADC development is a plus.
- Strong knowledge of CMC development processes, regulatory requirements (e.g., IND, BLA, NDA, IMPD), and GMP standards.
share this job.
the application process.
See what comes ahead in the application process. Find out how we help you land that job.
1 of 8apply with randstad.
Applying with us is easy. We will review your application and see if you are a good fit for the job and the company.
2 of 8we'll give you a call.
Our consultant will call you at a suitable time to discuss your application and further career aspirations.
3 of 8getting you registered.
If you’ve never worked with us before, we’ll need some basic additional pieces of information to confirm your eligibility for work.
4 of 8compliance check.
Next, we just need to verify a few things - we’ll make the relevant compliance checks and keep you posted.
5 of 8reference and background check.
As part of the process in ensuring you’re perfect for the role, we’ll make contact with any relevant references you’ve provided.
6 of 8the perfect job for you.
Our expert team will either arrange an interview for the role you’ve applied for, or if they believe there’s a better opportunity, they’ll suggest alternative options too.
7 of 8the interview.
We’ll ensure that you’re fully prepared ahead of your interview and know exactly what to expect - good luck!
8 of 8start your new job.
Congratulations, you’re ready to begin your new job. The team will ensure that you’re fully prepared for your first day.
let similar jobs come to you
We will keep you updated when we have similar job postings.
Thank you for subscribing to your personalised job alerts.