Principal Scientist, Small Molecule Analytical Chemistry
$173.2k - $272.6kMerck
Merck seeks a Principal Scientist to lead analytical chemistry efforts for small molecule drug product development and commercialization. The role involves managing a team, conducting method development and validation, supporting regulatory submissions, and mentoring scientists in a cGMP manufacturing environment.
Responsibilities
- Lead analytical team in method development, validation, testing, and investigations within cGMP environment
- Oversee drug product and manufacturing process characterization, stability studies, and specification development
- Support manufacturing process scale-up and validation activities
- Prepare CMC documents for global regulatory submissions and respond to regulatory inquiries
- Coordinate multi-project drug product development efforts and mentor scientists
Requirements
- PhD in Analytical Chemistry or related field with 7+ years small molecule pharmaceutical development experience; or MS with 10+ years
- Hands-on expertise with UHPLC/HPLC, dissolution, gas chromatography, UV/IR spectroscopy, and Karl Fischer titration
- Extensive method development and validation experience
- Significant experience authoring CTD sections for regulatory submissions (IND, NDA, MAA, JNDA)
- Demonstrated leadership, mentoring, and team management capabilities
- Strong problem-solving, communication, and interpersonal skills
- Experience with analytical technology transfers and regulatory strategy execution
Compensation: $173,200–$272,600 base
Vacancy posted 4 days ago
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