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Biologics Analytical Principal Scientist

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Randstad

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Location:
China , 苏州市

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Category:
-

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Contract Type:
Not provided

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Salary:

300000.00 - 600000.00 CNY / Year

Job Description:

As a Principal Scientist in Physicochemical Analysis, you will independently lead advanced method development, validation, and characterization for biologics (mAbs, ADCs) using core techniques including HPLC, UPLC, LC-MS, CE, and ICIEF. You will drive CMC compliance by designing complex studies (CQA assessment, comparability, stability), interpreting data, and preparing high-quality technical/regulatory documents to support global filings. This senior role requires 8+ years of innovator pharma experience, strong cross-functional leadership, and expertise to mentor teams and solve high-impact analytical challenges.

Job Responsibility:

  • Design and perform analytical support to biologics development from early to late stage
  • Analytical method development, transfer and troubleshooting for product quality control and stability study
  • Draft protocol/report and execute study to support IND/NDA filings
  • Participate in projects as ARD subject matter expert and provide professional guidance whenever needed

Requirements:

  • A Master’s degree in Analytical Chemistry, Pharmaceutical Sciences or a related field is required, with a strong technical foundation in physicochemical analysis
  • Profound expertise in key analytical techniques including HPLC, UPLC, LC-MS, CE and cIEF for biologics and ADC characterization is highly essential
  • The candidate should have 8+ years of progressive CMC experience in biopharmaceutical companies, with a proven record in method development, regulatory compliance and project leadership

Additional Information:

Job Posted:
April 23, 2026

Expiration:
June 28, 2026

Employment Type:
Fulltime
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