We are seeking a highly motivated and scientifically rigorous individual to join our team as a Research Associate, Analytical Development, CMC. The successful candidate will report to the Associate Director, Analytical Development, CMC and be an integral part of the CMC team. This position offers opportunities to contribute to the analytical development function within CMC and overall CMC strategy of drug development at Translate Bio. The successful candidate will be responsible for the development, validation and transfer of analytical methodologies, release and stability testing for drug substance, drug product and raw materials.
- Execute quality control activities as assigned by management including analysis of raw materials, drug substance and rug product samples. Prepare and analyze samples according to established QC test methods
- Work with project team members to support release of drug substance and drug product batches.
- Initiate and manage/coordinate stability studies substance and drug product and coordinate sample storage with vendor.
- Participate in method transfer activities, the maintenance and troubleshooting of laboratory equipment, and coordinate outsourcing of testing with vendors.
- Assist in technical review of analytical development supporting documents including protocols, reports and methods.
- Work with CMOs/CROs on technology transfer of assays to support development and CMC.
- Assist in the execution of analytical development experiments to improve platform analytic capabilities.
- Minimum of a Bachelors Degree in Chemistry.
- Minimum of 3 years experience or MS with one year of experience in the pharmaceutical chemistry, biochemistry field.
- Demonstrated success and analytical development knowledge/experience for raw materials in pharmaceuticals.
- Hands-on experience in multiple analytical techniques.
- Experience in analytical development is required, preferably within a pharmaceutical company setting or a CRO.
- Desire to work in a fast-paced environment
- Excellent organizational and communication skills
- Strong analytical and problem-solving skills
Translate Bio is committed to equal employment opportunity. All applicants must have authorization to work in the U.S.