# Principal Scientist, Large Molecule Analytical

Hiring organization: [Merck](https://career.thegoodapps.co/organizations/merck)

Canonical page: https://career.thegoodapps.co/jobs/c4199643-8923-4485-91f7-4c99538220b2

Listed on Merck's own careers site. Applications go to them directly.

- Employment type: full time
- Seniority: Principal
- Location: Rahway, NJ
- Salary: 156900 – 247000 USD per year

## Summary

A senior scientific leadership role directing the analytical characterization of biologic drugs, suitable for an experienced analytical chemist or biochemist ready to lead a team while developing advanced testing methods for complex protein-based medicines.

_Our summary, not Merck's wording._

## Skills named

Design of Experiments (DOE), Regulatory Affairs, Technical Writing

## Required

- Ph.D. in analytical chemistry, biochemistry or related field with minimum 8 years pharmaceutical industry experience (or equivalent with M.S./B.S. and additional years)
- Extensive experience analyzing biologics using chromatography and electrophoresis techniques
- Experience developing process and impurity assays using molecular biology and immunoassay methods
- Strong background in analytical control strategy development
- Demonstrated mentoring and matrix management experience
- Initiative, creativity and innovation in problem solving
- Understanding of Critical Quality Attributes, Quality by Design, Design of Experiments and statistical methods
- Ability to design and direct development of release, characterization and stability assays
- Team player with excellent verbal and written communication
- Authoring and reviewing technical reports and regulatory submissions
- Ability to deliver complex objectives under aggressive timelines

## Nice to have

- Understanding of protein degradation mechanisms
- Experience with assay qualification, validation and transfer to regulated GxP environments per ICH Q2 and USP standards
- Experience with complex glycan analysis
- Experience with multiple biologic modalities such as monoclonal antibodies, antibody-drug conjugates and fusion proteins
- Knowledge of antibody-drug conjugate method development
- Scientific reputation with publications and external presentations
- External network for competitor and vendor benchmarking
- Experience with high-throughput and data-rich experimentation

Apply on Merck's site: https://msd.wd5.myworkdayjobs.com/en-US/SearchJobs/job/USA---New-Jersey---Rahway/Principal-Scientist--Large-Molecule-Analytical_R402101