Expert* CMC Drug Product mAb & ADC

Open for hire at one of the following locations – Shanghai. - Job ID: 7364

Join our team of pioneers!

As a part of our team of more than 5.000 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards – writing medical history.

We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives.

Expert* CMC Drug Product mAb & ADC

The main responsibility of this role is to provide project overarching CMC support within the China affiliate and serve as a local interface for all clinical CMC project teams with Chinese collaboration partners, CDMOs, and vendors.

Specific tasks of this position include engaging directly with local collaboration partners, CDMOs, vendors, etc. to support formulation and Drug Product process development as well as GMP manufacturing for all mAb and ADC projects. This role also involves supporting operational & troubleshooting activities on-site, including on-demand person-in-plant for process development and clinical GMP production.

The CMC Expert Drug Product mAb & ADC will also support technical transfers to in-China and ex-China sites (focus clinical phase), internal audits, and HA inspections. Additionally, this role will support due diligence activities of new programs in China, including on-site visits, document translations, etc.

As cultural and operational facilitators for the CMC teams, the CMC Expert Drug Product mAb & ADC will leverage their 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 formulation and Drug Product process development as well as 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 diligences, etc)
• Subject matter expert support for internal audits and Health Authority inspections
  
  

What you have to offer:

• Master’s degree in Pharmacy, 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 formulation and Drug Product process technologies
• 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
  
  

Benefits for you

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.

Click here to find out more about what we do, the careers we offer and also the benefits we provide.

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.

Have we kindled your pioneering spirit?

This vacancy is to be hired at one of the following locations – Shanghai . Apply now for your preferred job and location through our careers site .

• BioNTech does not differentiate on the basis of race, colour, religion, creed, national origin or ancestry, ethnicity, sex (including gender, pregnancy, sexual orientation, and gender identity), age, physical or mental disability, citizenship, veteran status, genetic information, or any other characteristic protected by applicable law. We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important – it’s a match!