Shanghai, China | full time | Job ID: 11127
About the role:
- The main responsibility of this role is to provide project overarching drug substance support (mainly protein purification and ADC bioconjugation) and serve as a local interface for all clinical CMC project teams with Chinese collaboration partners, CDMOs, and vendors. In addition, the (Associate) Director Protein & ADC Drug Substance may also take dedicated responsibility as drug substance lead within global development projects.
- Specific tasks of this position include engaging directly with local collaboration partners, CDMOs, vendors, etc. to support drug substance development and GMP manufacturing for protein and ADC projects. This role also involves supporting operational & troubleshooting activities on-site
- The (Associate) Director Protein & ADC Drug substance will also support technical transfers to in-China and ex-China sites (focus clinical phase), internal audits, and Health Authority inspections
- As cultural and operational facilitators for the CMC teams, the (Associate) Director Protein & ADC Drug substance will leverage his/her language skills and local knowledge to resolve issues promptly. This role will also closely collaborate with Product Supply and Quality counterparts to enable efficient technical project handover to commercial operations
Your main responsibilities are:
- On-site operational support at collaboration partners and CDMOs for Drug Substance process development and clinical GMP production (person in plant, ad-hoc site visits for troubleshooting etc.)
- Review project documentation, including development reports, risk analysis, qualification/validation reports, batch records and release documentation according to regulatory guideline
- Translation of technical documents for technical transfer as well as due diligence activities
- Organization of technical visits at collaboration partners or CDMOs (project-related visits, technical transfers, due diligence, etc.)
- Subject matter expert support for internal audits and Health Authority inspections
A good match:
- Master’s degree in chemistry, Biopharmaceuticals, Biochemistry, Biology, or a comparable field with at least 5 years of relevant professional experience in an international and highly regulated environment
- Proven experience in mAb and ADC Drug Substance process technologies with preferably specific operational experience in mAb DSP or ADC bioconjugation
- Sound experience in CMC development of early- and late-stage projects, including strategy definition and strategy execution, with a sound understanding of all stages the drug development process
- Sound GMP knowledge and experience with regulatory filings for biologicals (IND/IMPD, BLA/MAA)
- Excellent project management skills, capable of working in cross-functional CMC teams and with external stakeholders
- Excellent communication and negotiation skills as well as ability to communicate complex technical matters in a clear and concise way to various stakeholders
Your Benefits:
BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience.
Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.
How to apply:
Apply now by sending us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details via our online form.
Please note:
Only applications sent via our online form shall be considered. By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.
We are looking forward receiving your application.
