Senior Principal Biologics Formulation Scientist

Dovetail Therapeutics; Seattle (WA); On-site; USD 140,000 - 200,000; Full time

Benefits offered by this job

Medical coverage

Dental & Vision

401(k) plan

Paid time off

Parking or transit

Job summary

Dovetail Therapeutics is seeking a Senior/Principal Formulation Scientist to join our Seattle CMC team. You will lead formulation development for novel biologics, from preclinical screening through IND-enabling and into clinical manufacturing, while coordinating with internal and external partners.

The role requires extensive expertise in biologics formulation, sterile injectable development, and regulatory documentation, with a track record of cross-functional leadership in fast-paced

Qualifications

• Experience in biologics formulation and drug product development from discovery to IND-enabling studies.
• Independent study design, execution oversight, and strategic interpretation of results.
• Experience with sterile injectable drug product development and fill-finish considerations.
• Strong understanding of CMC regulatory expectations and regulatory filings (IND/IMPD) preferred.

Responsibilities

• Advance formulation development strategy from early development to clinical readiness and commercial formulation.
• Design, oversee, and interpret formulation and stability studies to support selection and regulatory submissions.
• Collaborate with CMC, analytical, process development, quality, regulatory, and program teams to advance programs.
• Provide technical oversight of external CDMOs, CROs, and development partners; review protocols and reports.
• Compile and communicate data packages for milestones and regulatory submissions.
• Stay current with advances in biologics formulation and delivery technologies.

Skills

Biologics formulation

Drug product development

Analytical methods

Regulatory submissions

Project leadership

CDMOs oversight

Cross-functional collaboration

Education

PhD in Pharmaceutical Sciences

Master's degree

Bachelor's degree

Job description

Dovetail Therapeutics is seeking a Senior/Principal Formulation Scientist to join our Seattle CMC team. You will lead formulation development for novel biologics, from preclinical screening through IND-enabling and into clinical manufacturing, while coordinating with internal and external partners.

The role requires extensive expertise in biologics formulation, sterile injectable development, and regulatory documentation, with a track record of cross-functional leadership in fast-paced