We are seeking an experienced, impactful and highly motivated analytical scientist to join our CMC team as a Scientist Raw Materials, Analytical CMC. This individual will contribute to the analytical development function within CMC and overall CMC strategy of drug development at Translate Bio. This scientist will support the development, validation and transfer of analytical methodologies, release and stability testing for incoming raw materials. The incumbent in this role will have expert skills in pharmaceutical analytical chemistry as well as experience in raw materials management.
- Support raw materials analytical chemistry activities both internally and at contract laboratories with best practices of development
- Closely work with CRO to design and perform raw materials release and stability method development and validation employing phase-appropriate approaches at different stages of development
- Manage raw materials stability study programs
- Demonstrate extensive knowledge in state-of-the-art analytical technologies
- Authorized/review analytical method development reports, validation protocols/reports, instructions/SOP’s for raw materials analytical functions
- Knowledge of CMC product development process including, cGMP manufacturing, validation, process development. Previous experience/knowledge of routine mRNA and LNP productions and testing in support of Process Development and Research activities is preferable, but not required.
- Knowledge of GMP/ICH/FDA regulations for raw materials testing is required.
- Demonstrated competency and hands-on experience of typical chemistry manufacturing and controls (CMC) activities
- Familiarity with a full range of analytical techniques for characterization of raw materials in pharmaceuticals including RP/IEX/SEC HPLC, UPLC, LCMS, Karl Fisher, solid state characterization
- Organized, motivated, diligent, calm under pressure and able to work with multiple personality types
- Good attention to detail
- Excellent organizational skills, ability to multi-task in an extremely fast-paced environment with changing priorities.
- Strong oral and written communication skills.
- Ability to manage multiple projects and studies effectively.
- Reviews, interprets and communicates data cross-functionally within CMC and project teams.
- Ability to meet deadlines and demonstrate effective use of time.
- Ability to be flexible and responsive to change, be a results-driven problem solver.
- Minimum BS/MS with 7+/10+ years of analytical development experience in the pharmaceutical industry.
- Strong scientific knowledge in analytical chemistry
- Strong analytical development knowledge/experience for raw materials in pharmaceuticals
- Previous experience in analytical development in required, preferably within a pharmaceutical company setting or a CRO.
Translate Bio is committed to equal employment opportunity. All applicants must have authorization to work in the US.