Principal Scientist, Biologics Analytics & Development

Merck

New Jersey

On-site

USD 140,000 - 190,000

Full time

2 days ago
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Job summary

Merck in Rahway, New Jersey seeks an Associate Principal Scientist to lead analytical method development for complex biologics, enabling drug substance and product development. The role emphasizes design, qualification, transfer, and troubleshooting of assays in a fast-paced, collaborative team setting.

The candidate will work across chemistry, biology, and informatics, with responsibilities including development of new platforms, benchmarking against industry standards, and technical leadership

Qualifications

  • B.S./M.S./Ph.D. with relevant experience in analytical biology/biochemistry.
  • Strong background in separations and HPLC/UPLC of proteins.
  • Experience with assay development for release/characterization/stability testing.
  • Familiarity with DOE/QbD and statistical data analysis.
  • Ability to lead assay development and cross-functional transfers.
  • Experience authoring technical reports and contributing to filings.

Responsibilities

  • Develop, qualify, implement and troubleshoot analytical methods for monoclonal proteins.
  • Lead design-of-experiments and data interpretation for complex biologics.
  • Transfer assays to manufacturing and support regulatory filings.
  • Collaborate across biology, chemistry, and informatics to enable product development.

Skills

Separation science
UPLC/HPLC analysis
Biologics analysis
QbD/DOE principles
Assay development
Cross-functional teamwork
Regulatory writing support

Education

B.S. in Chemistry/Biochemistry/Engineering with 12 years experience
M.S. with 8 years experience
Ph.D. with 4 years experience

Job description

Merck in Rahway, New Jersey seeks an Associate Principal Scientist to lead analytical method development for complex biologics, enabling drug substance and product development. The role emphasizes design, qualification, transfer, and troubleshooting of assays in a fast-paced, collaborative team setting.

The candidate will work across chemistry, biology, and informatics, with responsibilities including development of new platforms, benchmarking against industry standards, and technical leadership

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