BioNTech SE

Director AS&T, mAb & ADC Network

BioNTech SE

full-time

Posted on:

Location Type: Office

Location: Shanghai • China

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Job Level

Lead

About the role

  • Provide project overarching analytical support within the China organization
  • Serve as a local interface for all clinical and commercial CMC project teams with Chinese collaboration partners, CDMOs, and vendors
  • Engage directly with local collaboration partners, CDMOs, vendors, etc. to facilitate analytical transfers and support quality control for mAb and ADC projects
  • Support operational & troubleshooting activities on-site
  • Review project documentation, including method development reports, analytical procedure protocols, method qualification/validation reports, according to regulatory guidelines
  • Independently drive assigned analytical packages within global technical operations
  • Ensure translation of technical documents for analytical transfer activities
  • Organization of technical visits at collaboration partners, CDMOs or vendors
  • Subject matter expert support for internal audits and Health Authority inspections

Requirements

  • Master’s degree or preferably PhD in Pharmacy, Chemistry, Biopharmaceuticals, Biochemistry, Biology, or a comparable field
  • At least 5 years of relevant professional experience in an international and highly regulated environment
  • Proven experience in protein and ADC analytical technologies (physico-chemical assays, functional assays, quality control)
  • Knowledge in small molecule analytics is considered a plus
  • Experience in analytical activities of late-stage and commercial projects
  • 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 concisely to various stakeholders
Benefits
  • Health insurance
  • Retirement plans
  • Paid time off
  • Flexible work arrangements
  • Professional development
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
analytical supportprotein analytical technologiesADC analytical technologiesphysico-chemical assaysfunctional assaysquality controlmethod developmentmethod qualificationmethod validationGMP knowledge
Soft Skills
project managementcommunication skillsnegotiation skillscross-functional collaborationstakeholder engagement
Certifications
Master’s degreePhD