Principal Scientist, Analytical Sciences – Drug Development
Merck & Co.
Get more replies from employers
Send a job-specific resume in minutes.
Job summary
Merck & Co. in Rahway, NJ seeks a Principal Scientist in Pharmaceutical Analytical Sciences to lead analytical development for small molecules, peptides, mRNA, oligonucleotides and bioconjugates.
You will guide method development, validation, and analytical characterization across drug substances and products, ensuring GMP compliance and readiness for regulatory submissions. The role emphasizes leadership, cross-functional collaboration, and the advancement of innovative analytical technologies
Qualifications
- A strong team player with excellent written and oral communication skills and leadership abilities.
- Proven ability to develop analytical control strategies and mentor junior staff.
- Experience authoring regulatory filing sections (IND/IMPD/NDA) and supporting submissions.
Responsibilities
- Lead analytical teams driving drug development from early to commercialization.
- Partner with cross-functional teams to design studies guiding product and process development.
- Define end-to-end analytical control strategies for clinical supplies under GMP.
- Author regulatory submissions (IND, IMPD, NDA/WMA) and respond to agency questions.
- Mentor and oversee junior scientists and communicate with governance bodies.
Skills
Education
Tools
Job description
Merck & Co. in Rahway, NJ seeks a Principal Scientist in Pharmaceutical Analytical Sciences to lead analytical development for small molecules, peptides, mRNA, oligonucleotides and bioconjugates.
You will guide method development, validation, and analytical characterization across drug substances and products, ensuring GMP compliance and readiness for regulatory submissions. The role emphasizes leadership, cross-functional collaboration, and the advancement of innovative analytical technologies
'/%3e%3cpath%20d='M101.744%2012.4726L102.894%2016.1947L99.0021%2013.2201L101.744%2012.4726ZM105.3%208.40937H100.488L99.0026%203.59473L97.5116%208.41047L92.7%208.40385L96.5965%2011.3834L95.1055%2016.1942L99.0021%2013.2196L101.408%2011.3834L105.3%208.40992V8.40937Z'%20fill='white'/%3e%3cdefs%3e%3clinearGradient%20id='paint0_linear_5593_1381'%20x1='90'%20y1='9.44471'%20x2='99'%20y2='9.44471'%20gradientUnits='userSpaceOnUse'%3e%3cstop%20stop-color='%2300AD70'/%3e%3cstop%20offset='0.998594'%20stop-color='%2300B67A'/%3e%3cstop%20offset='1'%20stop-color='%23DCDCE6'/%3e%3c/linearGradient%3e%3c/defs%3e%3c/svg%3e){kind=small}
