Principal Scientist / Associate Director, CMC Formulation Development

Job Description

Company and Role Description:

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Dovetail Therapeutics is a Seattle biopharmaceutical company founded in 2023 by the world’s leading healthcare venture capital firm OrbiMed. Dovetail is committed to developing novel biotherapeutics that will meaningfully improve the lives of patients. The company has established a transformative, proprietary platform and a robust, expanding pipeline, with its lead drug candidate entering the clinic this year. 

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Dovetail is seeking a talented and experienced Principal Scientist / Associate Director, CMC Formulation Development, to join our growing and dynamic CMC team. You will advance formulation development activities for novel biotherapeutics, including preclinical formulation screening, drug product development, stability strategy, and technical oversight of external development partners. If you are passionate about advancing innovative biologic therapies in a collaborative, fast-paced environment where your contributions will make a meaningful impact, this role is for you.

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Location: Seattle, WA (On-site, hybrid or fully remote).

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Key Duties and Responsibilities:

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·       Advance formulation development strategy for biologic drug candidates from early development through clinical readiness and commercial formulation, including pre-formulation assessment, excipient selection, formulation screening, drug product presentation strategy, container closure selection, compatibility studies, and in-use stability assessments.

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·       Design, oversee, and interpret formulation and stability studies to support candidate selection, process development, GMP manufacturing, and regulatory submissions.

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·       Partner closely with internal CMC, analytical, process development, quality, regulatory, and program teams to advance novel biotherapeutic programs and ensure alignment across development plans.

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·       Manage and provide technical oversight of external CDMOs, CROs, and development partners, including protocol review, study design, data analysis, troubleshooting, and technical report approval.

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·       Compile and communicate formulation development data packages for program milestones, regulatory submissions, and management.

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·       Apply innovative approaches and stay current with advances in biologics formulation, drug product development, delivery technologies, competitive landscape, and clinical learnings to strengthen existing programs and pipeline opportunities.

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Qualifications and Skills:

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·       Degree in Pharmaceutical Sciences, Chemistry/Biochemistry, Biophysics, Chemical Engineering, or a related discipline, plus industry experience of 6+ years with a PhD, 12+ years with a Master's, or 14+ years with a Bachelor's.

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·   Demonstrated expertise in biologics formulation and drug product development, including independent study design, execution oversight, and strategic interpretation, across discovery/preclinical through IND-enabling activities and clinical manufacturing.

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·       Proven skill implementing and troubleshooting chromatographic, biophysical, and analytical methods to characterize structural attributes, stability, and degradation mechanisms of protein biologics, supporting CMC characterization and stability studies from early- through late-stage development.

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·       Experience with sterile injectable drug product development, including liquid formulations, container closure systems, fill-finish considerations, and compatibility with manufacturing and clinical administration components.

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·       Proven ability to design studies, analyze complex data sets, identify development risks, and provide clear technical recommendations to cross-functional project teams and leadership.

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·       Experience working with external CDMOs and CROs, including technical oversight, protocol and report review, issue resolution, and timeline management.

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·       Working knowledge of CMC regulatory expectations for biologic drug product development, with experience with technical reports and development documentation; experience authoring and reviewing regulatory filings (e.g., IND, IMPD) is preferred.

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·       Self-driven and proactive, with the ability to advance projects, manage multiple priorities, and adapt to evolving objectives in a fast-paced environment.

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·       Excellent organizational, communication, and collaboration skills, with strong attention to detail and a commitment to high-quality scientific documentation.

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Benefits:

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We foster a culture of collaboration and innovation, with each team member playing a critical role in shaping our success. Dovetail offers a competitive total compensation and benefits package. Benefits include medical, dental and vision coverage, paid parking or transit, a 401(k) plan, and paid time off, among other components. Dovetail Therapeutics is located at 1616 Eastlake Avenue East, in the vibrant South Lake Union neighborhood of Seattle.