We are seeking a highly motivated and scientifically rigorous individual to join our team as a Scientist, CMC. The successful candidate will report to Senior Scientist CMC and be an integral part of the CMC team. The position will focus on drug substance and drug product manufacturing, regulatory and analytical support, including development, validation, and data review for drug substances and drug products. The position will help develop and execute scalable and robust formulation processes for drug substance and drug product and help serve as the process knowledge link between Process Development and drug substance and drug product manufacturing.
- Design and conduct experiments to improve and optimize drug substance and drug product manufacturing processes.
- Support technology transfer of mRNA and nanoparticle manufacturing processes to internal and external partners
- Identify solutions, including process analytical technologies, which lead to robust process control strategies
- Provide technical support for scale-up and manufacturing issues, and develop solutions to improve process efficiency and product quality
- Prepare technical reports and presentations that support scale-up activities and process improvements
- Develop and Review manufacturing batch records and protocols
- Support and contribute to IND filings/regulatory documentation Qualifications
- Bachelor’s or Master’s degree in Chemistry, Chemical engineering or Biochemistry is required
- 5-10 years of experience working in a pharmaceutical or biotechnology company is required
- Demonstrated leadership in process development, scale-up, and/or 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.
- Prior experience working with nucleic acid therapeutics and nanoparticle delivery systems is desired
- 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.