Sr. Scientist 1

Role and Responsibilities
- Plan experimental strategy and formulation development across non-clinical and clinical phases for small molecules, oligos, and peptides.
- Design technical strategies to resolve formulation/process issues; lead drug product formulation development and optimization.
- Lead the cross-functional CMC Drug Product Partner Team; represent the team in CMC forums and Core Team meetings.
- Coordinate with partner teams to develop options for CMC decision-making; interpret outcomes and provide integrated recommendations.
- Ensure clear communication across the Drug Product Partner Team, CMC, and functional management.
- Identify/mitigate/escalate risks (quality, timelines, scope); track and report milestones/deliverables to the CMC Project Manager.
- Support CDMO selection, due diligence, and site evaluations; review protocols/reports and contribute to regulatory submission content.

Required / Preferred Qualifications
- Drug product development experience, preferably solid oral dosage forms (may serve as SME or Drug Product Partner Team Lead).
- Experience leading multi-disciplinary, cross-functional activities to deliver CMC deliverables.
- Hands-on solid oral dosage form development (tablets, capsules, oral solutions), including pre-formulation.
- Experience with parenteral drug product formulation development and CMC regulatory guidance/filings.
- Strong leadership, organization, prioritization, written/verbal communication, and ability to meet deadlines in a fast-paced environment.
- Broad knowledge of regulatory, scientific, and technical issues for drug development applications.
- Experience authoring/reviewing CMC sections for regulatory filings; excellent technical writing.
- Preferred: gene therapy drug product development; GMP knowledge.

Education
- Ph.D. (Biochemistry/Pharmaceutics Sciences or related) with 5+ years industry experience, or MS/BS with extensive industry experience.