Senior QC Scientist - GMP Method Transfer Lead

Pharmaron Beijing Co. Ltd.

Coventry (RI)

On-site

USD 100,000 - 140,000

Full time

3 days ago
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Benefits offered by this job

Medical Insurance
401(k) Retirement Plan
Paid Time Off

Job summary

Pharmaron Beijing Co. Ltd. is seeking a Senior Scientist, QC, to support technology transfer and GMP manufacturing through analytical method transfer, verification, validation and sample testing in compliance with regulatory guidelines.

The role includes supervising QC staff, coordinating testing, reviewing data, and participating in investigations and audits to ensure high-quality QC output in a fast-paced, matrix environment.

Qualifications

  • MS with 8+ years of pharmaceutical QC experience
  • BS with 10 years of pharmaceutical QC experience
  • Experience applying analytical skills to method transfer/validation
  • Strong troubleshooting and problem-solving abilities
  • Supervisory experience of QC staff and cross-functional teams
  • Knowledge of cGLP/cGMP and FDA/EMA/ICH guidance

Responsibilities

  • Participate in method transfer activities, write protocols and reports
  • Supervise QC scientists and provide guidance
  • Review data, notebooks, methods, protocols and reports
  • Investigate deviations and write investigation reports
  • Coordinate QC testing and data reviews
  • Present data summaries to cross-functional teams
  • Maintain GMP compliance and proper documentation
  • Support site audits and instrument training

Skills

Analytical skills
Troubleshooting
Staff supervision
cGMP knowledge
Cross-functional collaboration

Education

MS with 8+ years
BS with 10 years

Tools

HPLC
GC
FTIR
Mass Spectrometry

Job description

Pharmaron Beijing Co. Ltd. is seeking a Senior Scientist, QC, to support technology transfer and GMP manufacturing through analytical method transfer, verification, validation and sample testing in compliance with regulatory guidelines.

The role includes supervising QC staff, coordinating testing, reviewing data, and participating in investigations and audits to ensure high-quality QC output in a fast-paced, matrix environment.

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