Bioanalytical Portfolio Scientist

Amgen Australia Pty Ltd

Base: 109,020.15usd - 147,497.85 usd; bonus/equity...
Hybrid
Technical subject matter expert
Outsourced methods
Method validation
Serve as the technical subject matter expert for outsourced methods and is responsible to ensure adequate method validation and optimal method performance at CROs

Job Summary

  • Serve as the technical subject matter expert for outsourced methods and is responsible to ensure adequate method validation and optimal method performance at CROs.
  • Provide scientific and technical oversight of bioanalytical activities (including pharmacokinetic [PK] and toxicokinetic [TK] analyses) performed by external contract research organizations (CROs), ensuring adherence to validated methods, data integrity standards, and alignment with study protocols and regulatory requirements.
  • Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities.

Matching Summary

Serve as the technical subject matter expert for outsourced methods and is responsible to ensure adequate method validation and optimal method performance at CROs.

Salary

Base: 109,020.15USD - 147,497.85 USD; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

  • technical subject matter expert
  • outsourced methods
  • method validation
  • method performance
  • GLP/GCP principles
  • pharmacokinetic (PK) and toxicokinetic (TK) analyses
  • quantitative ligand-binding assays (LBA)
  • LC-MS bioanalysis

Nice-to-have

  • collaborative manner
  • continuous improvement efforts
  • cross functional partners
  • supplier evaluation and monitoring

Key Requirements

  • Doctorate degree OR Master’s degree and 2 years of regulated commercial scientific laboratory experience OR Bachelor’s degree and 4 years of regulated commercial scientific laboratory experience OR Associate’s degree and 8 years of regulated commercial scientific laboratory experience OR High school diploma / GED and 10 years of regulated commercial scientific laboratory experience
  • Strong project management experience
  • Fluency in English
  • Knowledgeable on current relevant regulatory guidance/regulations (e.g. FDA, ICH, EMEA, NMPA)
  • Experienced in working with CROs

Work Rights

Not specified

Tailored Resume

Cover Letter