Scientist, CMC

Job Description

We are seeking a highly motivated and scientifically rigorous individual to join our team as a Scientist, CMC. The successful candidate will report to the Associate Director, 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 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.

Responsibilities

 Lead technology transfer of mRNA and nanoparticle manufacturing processes to internal and/or external manufacturing partners
 Design and conduct experiments to facilitate and support scale up of drug substance and drug product manufacturing processes. Design experiments to evaluate and assess critical process parameters for scale up of drug substance and drug product manufacturing.
 Lead and support startup of GMP manufacturing equipment including factoring acceptance testing, site acceptance testing, and/or IQ/OQ/PQ testing.
 Prepare technical reports and presentations that support scale-up activities and process improvements
 Design and conduct experiments to investigate the impact of formulation parameters on drug product processes
 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
 Support and contribute to IND filings/regulatory documentation

Required Skills

 A 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. A minimum of 3 years working in a GMP environment is preferred.
 Demonstrated experience in process development/scale-up of drug product formulation is required
 A familiarity and hands-on experience with the development of novel drug carriers using nanoparticle formulations is required
 Experience with analytical tools for release and characterization of drug product processes and drug products 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, including drafting batch records, standard operating procedures, and/or protocols.
 Familiarity with cGMP, ICH and regulatory guidelines
 Ability to partner with CROs/CMOs
 Excellent organizational and communication skills
 Strong operational execution and problem-solving skills are desired
 Desire to work in a fast-paced, deadline-driven environment
 Excellent organizational and communication skills
 Strong analytical and problem-solving skills