Principal Scientist, Downstream Process Development
This is a clinical-stage biotechnology company focused on developing immunotherapies to transform outcomes for patients with cancer. Backed by a group of leading institutional life sciences investors, they are advancing a portfolio of viral immunotherapy candidates based on their platforms for multiple indications with significant unmet needs. The team is driving innovation and engineering multiple candidates with both platforms to enable them to deliver on the full potential of this exciting therapeutic class. Every cancer patient deserves a better outcome. And they're working with urgency to make that happen.
We are looking for a stellar scientist to lead technical CMC activities. Reporting to the Director of Process Development, this individual will be a technical and development leader for our programs. This individual will play an enormous role in helping us to realize the full potential of our programs, starting with the first clinical candidate. Additionally, this individual will be a motivated leader, with a passion for bringing new treatments forward, a strong presenter and communicator, with the ability to work in a fast-paced and team-oriented environment. This individual will be excited by a lean and changing organization and by the opportunity to wear many hats in a very collaborative environment.
This is also an opportunity to grow as a leader in the CMC Operations group and to be a part of a groundbreaking, growing company.
- Partners with the Research and Process Development Teams and external consultants to translate our science into an efficient GMP manufacturing process
- Contributes to CMO selection, facility fit assessment, and development of batch production records
- Design and conduct experiments to identify and optimize critical process parameters and characterize early and late stage drug product manufacturing processes
- Manage relationships with CMOs and other vendors
- Work with the analytic assay development team to establish methods for characterization
- Prepare and review GMP and regulatory documents such as batch records, investigations, and IND sections
- Provide supervision to junior staff contributing to process development and technical operations
- Bachelor's or Master's degree (+10 years) or PhD (+6 years) experience in research, development, or manufacturing of biologics
- Degree in Chemical Engineering, Chemistry, Biomedical Engineering or Pharmaceutical Sciences or related field
- Demonstrated leadership in process development, scale-up, tech transfer, and external manufacturing
- Knowledge of bioprocess purification unit operations as applied to protein, viruses, DNA, RNA, or similar biomolecules
- Experience developing oligonucleotide therapeutics and/or lipid nanoparticle drug products a plus
- Deep understanding of analytical methods required for development and characterization of oligonucleotides, and lipid nanoparticles desired
- Strong interpersonal and collaboration skills
- Excellent written and oral communication skills
- Strong mentorship abilities