Role Summary
Principal Scientist to join the Protein Sciences team to drive cell line and upstream process development for the production of monoclonal antibodies and antibody-oligo conjugates. The candidate will work across functions to advance molecules from discovery through to clinical readiness and will oversee all activities at selected CDMOs. The role requires deep expertise in cell line development and will act as the liaison between Research and CMC to ensure a smooth transition from discovery to manufacturing. This onsite position is located at our Kendall Square offices in Cambridge, MA.
Responsibilities
- Lead the development, selection, and characterization of stable, high-titer cell lines for the production of monoclonal antibodies and antibody-oligo conjugates.
- Evaluate, select, and manage CDMOs to execute regulatory-compliant cell line development activities including clonality documentation and cell bank generation.
- Supervise all cell line development processes including construct design, generation of stable pools, clone screening, characterization, and cell line stability.
- Analyze protocols, development reports, and other data packages generated by CDMOs.
- Ensure activities completed at CDMOs align with project goals, timelines, and quality standards.
- Support regulatory filings by authoring and reviewing relevant sections related to cell line development.
- Work cross-functionally with internal teams including research, CMC, regulatory, and clinical to ensure seamless transfer of knowledge.
- Contribute to a cross-functional team of biologists, chemists, and pharmacologists to drive the strategic direction of research programs across multiple therapeutic modalities.
Qualifications
- Ph.D. in Chemical Engineering, Biochemical Engineering, Pharmaceutical Sciences, Biology, or related field with 6-10 years of relevant experience.
- Deep expertise in cell line development for production of therapeutic proteins including monoclonal antibodies, antibody-drug conjugates, or antibody-oligo conjugates.
- Strong technical background in all aspects of cell line development including molecular biology, vector design, single cell cloning technologies, cell line characterization, and industry-leading antibody production platforms.
- Additional expertise in antibody design and protein engineering is a plus.
- Proven track record of managing CDMOs and delivering on biologics development programs.
- Experience working across multiple projects simultaneously in a fast-paced, cross-functional environment.
- Excellent written/oral communication, organizational, and interpersonal skills are required to work effectively across teams.