Job Title: Senior Scientist/Senior Engineer Technical Transfer
Job Number: 20384
Location: Lexington, MA
We are seeking a highly motivated and scientifically rigorous individual to join our CMC team as a Scientist. This individual will focus on drug substance and drug product manufacture, regulatory and analytical support, including 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 substance and drug product in addition to serving as the process knowledge link between Process Development and Drug Substance and Drug Product manufacturing.
- Demonstrated experience 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.
- Support and contribute to IND filings/regulatory documentation.
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.
- Bachelor’s Degree in Chemistry, Biochemistry, Chemical engineering or a related field with 10+ years of experience. A Master’s degree with 6+ years of experience is preferred. PhD with 2+ years ·
- 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.