Lead Analytical Scientist, Drug Development
Merck
Obtenez une réponse de cet employeur
Votre CV et votre lettre de motivation, adaptés exactement à ce que l’employeur recherche.
Résumé du poste
Merck in Rahway, NJ seeks a Principal Scientist to lead analytical development across drugs from early development to commercialization. You will guide study design, ensure GMP compliance, and drive data-driven decisions throughout the pipeline.
You will mentor junior scientists, collaborate with cross-functional teams, and author regulatory documents while advancing novel analytical technologies for enhanced product characterization.
Qualifications
- PhD with 7+ years pharma industry experience or
- MS with 10+ years pharma industry experience or
- BS with 12+ years pharma industry experience
Responsabilités
- Lead analytical teams developing drugs from early development through commercialization.
- Partner with cross-functional areas to design scientific studies guiding product development.
- Define end-to-end analytical strategies for clinical supplies under GMP (development, validation, specs).
- Draft IND/IMPD/NDA/WMA submissions and respond to agency questions.
- Promote scientific excellence and regulatory influence within the organization.
- Adopt novel analytical technologies for product and process characterization.
- Mentor junior scientists and represent the team in governance settings.
- Collaborate with external partners and vendors to advance analytical capabilities.
Connaissances
Formation
Description du poste
Merck in Rahway, NJ seeks a Principal Scientist to lead analytical development across drugs from early development to commercialization. You will guide study design, ensure GMP compliance, and drive data-driven decisions throughout the pipeline.
You will mentor junior scientists, collaborate with cross-functional teams, and author regulatory documents while advancing novel analytical technologies for enhanced product characterization.
'/%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}
