Director of Maintenance responsible for maintenance operations at Hyundai Translead's new facility in Joliet. Leading multi - disciplinary teams and ensuring equipment reliability and safety standards.
About the role
- Director AS&T role providing analytical and quality control support for mAb and ADC projects at BioNTech in Shanghai. Engage with partners and ensure regulatory compliance while supporting operational activities.
Responsibilities
- 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
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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