Job Title: Scientist/Engineer Technical Transfer
Job Number: 20889
Location: Lexington, MA
Translate Bio is seeking a highly motivated and scientifically accomplished individual to join our CMC team. This role will contribute to both scientific and engineering elements of our process development function and has the flexibility of being titled as a Scientist or Engineer. This individual will be focused on drug substance and drug product manufacturing, regulatory support and analytical support. This includes development, validation, and data review for drug substances and drug products. The scientist will assist in the development of scalable and robust formulation processes for drug product in addition to serving as the process knowledge link between Process Development and Drug Substance and Drug Product manufacturing.
· Provide hands-on support in process development/scale-up of drug substance and/or product formulation.
· Design and conduct experiments to investigate the impact of formulation parameters on drug product and/or drug substance processes
· Assist in coordinating technology transfer of mRNA and nanoparticle manufacturing processes to CMOs.
· Identify solutions, including process analytical technologies which lead to robust process control strategies.
· Prepare technical reports and presentations that support scale-up activities and process improvements.
· Review manufacturing batch records and protocols.
· Oversee and manage tech transfer activities to CMO, CRO and CDMO partners
· Manage process development initiatives in both cGMP and non cGMP capacities · Support and contribute to IND filings/regulatory documentation
· Bachelor’s Degree in Chemistry, Chemical engineering or a related field with 7+ years of experience. A Master’s degree with 3 – 5 years of experience is preferred.
· Ability to work with and collaborate with multiple CROs/CMOs.
· Desire to work in a fast-paced environment.
· Excellent organizational and communication skills.
· Operational execution and problem-solving skills.
Translate Bio is committed to equal employment opportunity. All applicants must have authorization to work in the U.S.
Key Skills and Competencies
· Familiarity with nucleic acid delivery and the development of novel nanoparticle formulations is preferred.
· Demonstrated ability to apply fundamental scientific and engineering skills to evaluation of processes and development of practical solutions to technical challenges.
· Experience with analytical tools for release and characterization of drug product processes and drug products.
· Familiar with cGMP, ICH and regulatory guidelines.