Position Overview:
- Principal Scientist, Chemical Development supporting small molecule process development and manufacturing for ADC small molecule linker-payload targets.
Responsibilities:
- Provide technical leadership for the chemical development team; align with company goals.
- Serve as technical lead on at least one program and as an individual contributor.
- Guide external partners for antibody drug conjugates, radiopharmaceuticals, and other lead programs.
- Support bench work as needed.
- Develop robust synthetic processes; devise alternative routes to APIs to reduce COGs and manufacturing lead times.
- Create data packages for technical transfer to external CMOs.
- Collect and review analytical data (internal and at external partners).
- Author regulatory document sections (IND, IMPD, NDA, briefing books) and provide SME support.
- Execute integrated CMC regulatory strategies; collaborate with research, regulatory affairs, and CMC teams.
- Provide CMC feedback on synthetic routes/raw materials; collaborate with discovery chemistry.
- Stay current on synthetic methodology; advance intellectual property.
- Ensure compliance with regulatory guidelines and industry standards.
Qualifications:
- PhD in Synthetic Organic Chemistry (or similar) and 7+ years industry experience leading small molecule and/or linker-payload programs.
- Technical lead experience overseeing tech transfer and process development/implementation (plus).
- Occasional evening/weekend commitment.
- Travel: 5β15%.
Skills:
- Cost-effective, robust manufacturing process design and rapid troubleshooting.
- Collaborative, detail-oriented; capable at bench and managing external partners.
- Proficient in analytical data generation/evaluation; writing technical reports and presentations.
- Knowledge of cGMP and ICH guidelines for CMC small-molecule drug-substance development.
- Strong interpersonal/communication skills; track record working cross-functionally.
Compensation:
- Washington State pay range: $169,593 - $206,233 USD.