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Location
無錫市
Salary
Competitive Salary
Job Type
Permanent
Ref
BH-19511
Contact
Richard Hao
Contact email
Email Richard
Posted
11日前
Wuxi, China
Industry: Medical devices, Life Sciences
 
My client is a prominent manufacturer and supplier of flow cytometry products and services. As a fast-growing company, their goal is to provide comprehensive solutions for advanced cell analysis. They are currently looking for an experienced and motivated candidate to lead their flow cytometry reagent department, which develops and supplies reagents to the global market for research and clinical applications. The main responsibilities of this role include new product introduction (NPI), manufacturing, quality control, and overall operations. The ideal candidate should have knowledge and experience in flow cytometry reagent or other immune assay reagent manufacturing operations.
 
Job Description Summary 
 
Primary Responsibilities:
  • New Reagent Introduction
    • Follow ISO13485 to adopt/establish new reagent production transfer process.
    • Work with reagent R&D team to optimize the reagent manufacture and QC procedures.
    • Create work instructions and associated forms.
    • Work with marketing to launch new reagent products, including design product packages, create part numbers, and build BOMs.
  • Reagent manufacture and QC
    • Buil antibody fluorescent dye conjugation and purification capabilities, including different classes of fluorescent dyes such as small molecules, protein, protein tandem, and polymers.
    • Buil large scale fluorescent dye labeled antibody production capabilities from conjugation, purification, formulation, bottling to final release.
    • Manage inventories of raw materials, intermediate products, and final products.
  • Reagent operation
    • Work with marketing, sales, and logistic team in reagent production planning
    • Define the inventory levels, re-build trigger, and reagent order turnaround time.

Experience and Qualifications:
  • BS, MS, or Ph.D. major in chemistry, protein chemistry, biochemistry, or related field.
  • Minimum 10+ years’ experience in antibody reagent manufacture and operation under ISO13485 quality system.
  • Experience in managing direct reports is required.
  • Experience in SOP and Work instruction writing under IS013485 is preferred.
  • Experience in fluorescent antibody labeling and purification is preferred.
  • Knowledge of flow cytometry application in research and clinical application is a plus.
  • Good knowledge of flow cytometer reagents.
  • Self-motivated, efficient, team player, and productive.
  • Excellent written, and oral communication skills.
  • Proficient in English


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