
Senior Scientist - Analytical Chemistry
16h16 hours agoMSD
Rahway, US · Full-time · $117,000 – $184,200
About this role
The Analytical Commercialization Technology (ACT) group within Analytical Chemistry in Development and Supply (ACDS) seeks a Senior Scientist at the Rahway site. The successful candidate will utilize innovative analytical characterization technologies. These efforts drive late-stage pharmaceutical drug product development and commercialization.
Daily responsibilities encompass analytical method development and validation, drug product testing, and analytical investigations in a cGMP environment. Additional tasks include drug product and manufacturing process characterization, stability studies, and specification development. Support extends to manufacturing process scale-up, validation, and preparation of CMC documents for regulatory submissions.
The role requires collaboration in a dynamic, integrated, and multidisciplinary team environment. Effective cross-functional interactions are essential for success. Strong organizational skills, multi-tasking, and problem-solving abilities support these team dynamics.
The ideal candidate possesses knowledge and proficiency in separation techniques and recent advances in analytical technologies. Excellent oral and written communication skills enable responses to regulatory questions. This position offers opportunities to influence global regulatory submissions and commercialization processes.
Requirements
- PhD in Analytical Chemistry or related discipline
- Strong background and extensive hands-on experience with UHPLC/HPLC, Gas Chromatography, UV and IR spectroscopy, Karl Fischer titration, and dissolution
- Strong chemistry knowledge
- Demonstrated problem solving ability
- Excellent verbal and written communication skills, demonstrated creativity, and strong interpersonal skills
- Ability to work in a team environment with cross-functional interactions
- Knowledge and proficiency in separation techniques
- Proficiency in recent advances in analytical technologies
Responsibilities
- Utilize innovative analytical characterization technologies to drive late-stage pharmaceutical drug product development and commercialization
- Develop and validate analytical methods
- Conduct drug product testing and analytical investigations in a cGMP environment
- Characterize drug product and manufacturing processes
- Perform drug product stability studies
- Develop specifications
- Support manufacturing process scale-up and validation
- Prepare Chemistry, Manufacturing, and Controls (CMC) documents for global regulatory submissions
- Respond to regulatory questions
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