Job Title: Contractor – Ph 2 Tech Transfer (Lyophilization), CMC
Job Number: 25350
Location: Lexington, MA
We are seeking a highly motivated and scientifically rigorous individual to join our team to assist with the tech transfer of our Ph2 drug product to a lyo fill/finish CMO. The position will focus on the tech transfer of drug product fill/finish, regulatory and analytical support.
- Experience with Ph2 lyophilization tech transfer
- Experience working at/with a GMP fill/finish site
- Experience with lyophilization scale up with good understanding of scientific principles involved in lyophilization.
- Familiar with analytical assays used for the release of lyophilized products.
- Experience working with multiple GMP mfg CMOs simultaneously
- Prepare technical reports and presentations for clear communication of scientific findings and/or project updates across interdisciplinary teams
- Bachelor’s or Master’s degree in Chemistry, Chemical engineering or engineering equivalent is desired
- Minimum 10 years of experience working in a pharmaceutical or biotechnology company is required
- Demonstrated leadership in tech transfer of drug substance and drug product processes is required
- Demonstrated ability to apply fundamental scientific and engineering skills for evaluation of processes and development of practical solutions to technical challenges is required.
- Must have experience working with GMP pharmaceutical manufacturing unit operations
- Strong familiarity with cGMP, ICH and regulatory guidelines
- Ability to partner with CROs/CMOs
- 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.