Senior Manager, Bioanalysis (Biotech)

Location: Shanghai, China

Company

hirify.global develops medicines and healthcare solutions across immunology, oncology, neuroscience, and aesthetics.

What you will do

• Coordinate bioanalysis strategies for China clinical development with global bioanalysis and China project teams.
• Plan and oversee method transfer, cross-validation, bioassays, immunogenicity assays, and analytical methods for biological samples.
• Manage China CRO activities, including sample analysis, data generation, reporting, translation review, and data transfer.
• Coordinate cross-functional teams to track biosample and bioanalysis activities and deliver results on time.
• Prepare and review China-specific bioanalysis documentation, including HGRAC submission materials and sample exportation justifications.
• Provide expert guidance on bioanalytical issues and ensure compliance with GLP, GCP, FDA, ICH, OECD, and NMPA requirements.

Requirements

• Master’s degree or higher in a scientific discipline.
• At least 2 years of experience as a principal investigator in a regulated bioanalysis laboratory, bioanalysis representative at a sponsor, or equivalent.
• Strong knowledge of protein biochemistry, regulated bioanalysis, and analytical method development and validation for proteins or biomarkers in biological matrices.
• Experience working with China CROs, biosample exportation/importation, and relevant Chinese regulatory requirements.
• Profound written and spoken English, with effective communication skills for internal and external stakeholders.
• Strong knowledge of GLP and GCP principles, problem-solving ability, and experience supporting bioanalytical data submissions for clinical studies.

Nice to have

• Experience with regulatory submissions supporting MRCTs, including CDE submissions; FDA experience is preferred.

Culture & Benefits

• Work with global bioanalysis, outsourcing, and China project teams.
• Participate in local and global clinical development project teams.
• Support innovative medicines and solutions addressing serious health issues.
• Equal opportunity employment with a commitment to integrity, innovation, and community service.