Job Title: Scientist, Analytical CMC
Job Number: 20383
Location: Lexington, MA
Translate Bio is seeking an experienced Analytical Scientist to join our CMC group. This individual in this role will contribute to the analytical development function within CMC and overall CMC strategy of drug development at Translate Bio. He/She will support the development, validation and transfer of analytical methodologies for incoming raw materials, in-process, drug substance, drug product release and stability testing. The successful individual will have expertise in pharmaceutical analytical chemistry as well as experience in authoring CMC sections of regulatory submissions.
- Manage analytical chemistry activities both internally and at external contract laboratories
- Guide CRO to design and perform method development and validation, employing phase-appropriate approaches at different stages of development
- Develop phase-appropriate quality control strategy for drug substance and drug product
- Manage product stability study programs
- Demonstrate extensive knowledge in state-of-the-art analytical technologies
- Authorize/review analytical method development reports, validation protocols/reports, instructions/SOP’s for relevant analytical functions, and analytical sections in IND and IMPD filings
- Manage internal analytical development laboratory and analytical personnel to support pipeline programs
- Provide technical advice to analytical scientists and associates to assure the highest quality of data is developed and presented
- PhD in analytical chemistry with 2+ years or MS with 7+ years’ of analytical development experience in the pharmaceutical industry.
- Excellent scientific knowledge in analytical chemistry, strong analytical development experience for drug substance and drug product.
- Familiarity with a full range of analytical techniques for characterization of pharmaceuticals including RP/IEX/SEC HPLC, UPLC, LCMS, Karl Fisher, solid state characterization, CE spectrophotometry.
- Experienced in CMC product development process including; cGMP manufacturing, validation, and process development.
- Demonstrated competency and hands-on experience of typical chemistry manufacturing and controls (CMC) activities.
- Experience drafting analytical sections of INDs and NDAs.
- Knowledge of GMP/ICH/FDA regulations is required.
- Experience managing CROs and CMOs.
- Previous experience/knowledge of routine mRNA and LNP production and testing in support of Process Development and Research activities is preferable, but not required.
- 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.