Overview As Principal Scientist in the Analytical Commercialization Technology group, you will lead a collaborative team to advance late-stage small molecule drug product development and commercialization. You will work in a cGMP environment to develop and validate analytical methods, perform drug product testing, and contribute to scalable manufacturing and regulatory submissions. Your role connects technical, regulatory, research, and manufacturing teams to drive multiple projects forward. You will mentor scientists and help sustain our scientific capabilities, shaping how we deliver health solutions.
Compensation / Benefits- annual bonus
- long-term incentive
- comprehensive benefits including medical/dental/vision
- retirement plan (401(k
- paid holidays
- vacation and sick leave
Responsibilities- Lead analytical method development and validation, drug product testing, and investigations in a cGMP setting
- Oversee drug product and manufacturing process characterization, stability studies, and specification development
- Support manufacturing process scale-up and validation activities
- Prepare CMC documentation for global regulatory submissions and respond to questions
- Collaborate with cross-functional teams including regulatory, research, and manufacturing
- Coordinate drug product development efforts and drive progress across multiple projects
- Mentor scientists and build/maintain the organization's scientific capabilities
Key requirements- PhD in Analytical Chemistry or related discipline with 7+ years of relevant small molecule pharmaceutical development experience; or MS with 10+ years
- Strong hands-on experience with UHPLC/HPLC, dissolution, GC, UV, IR, and Karl Fischer titration
- Extensive experience in method development and validation
- Experience authoring regulatory submission CTD sections (IND, NDA, MAA, JNDA, etc.)
- Proven problem-solving ability, excellent communication skills, and strong interpersonal skills
- Team-oriented with cross-functional collaboration and mentoring experience
- Experience in analytical technology transfers and regulatory strategy planning
- communication excellence
- leadership and mentorship
- problem-solving and creativity
- UHPLC/HPLC
- Dissolution
- Gas Chromatography
