This job has closed.

Tune Therapeutics · 5 days ago

Principal Analytical Scientist

Durham, NC

Full-time

Onsite

Lead/Staff

8+ years exp

Tune Therapeutics is a cutting-edge biotechnology company striving to develop paradigm-changing cell and gene therapies. The Principal Analytical Scientist will provide scientific leadership for impurity characterization and assay development, ensuring compliance with regulatory standards while leading cross-functional teams in drug substance and drug product programs.

BiotechnologyHealth CareTherapeutics

Hiring Manager

Tyler Goodwin, Ph.D.

Responsibilities

Drive the development, qualification, validation, and lifecycle management of analytical methods for impurity characterization of LNP, sgRNA, and mRNA DS and DP

Establish and execute impurity risk assessments, identification strategies, and justification of impurity limits aligned with ICH, regulatory guidance, and platform knowledge

Serve as the subject matter expert (SME) for process- and product-related impurities, including:

Process-related impurities (e.g., residual solvents, reagents, enzymes, lipids)

Product-related impurities (e.g., truncated RNA species, dsRNA, aggregates, degradation products)

LNP-specific impurities and attributes (e.g., lipid-related impurities, encapsulation-related species)

Design and implement phase-appropriate control strategies, linking analytical data to manufacturing process understanding and critical quality attributes (CQAs)

Develop orthogonal analytical techniques (LC, CE, electrophoresis, mass spectrometry, next generation sequencing, nanopore long read sequencing) for impurity detection and characterization

Ensure analytical methods are robust, fit-for-purpose, and compliant with GMP and regulatory expectations

Provide technical review and approval of method protocols, reports, specifications, and validation documentation

Partner closely with cross-functional stakeholders to align impurity strategies with process changes and product lifecycle

Support IND, CTA, BLA/MAA filings through authorship and review of analytical sections, impurity justifications, and responses to regulatory questions

Represent Analytical Development in program teams and governance forums, influencing technical and strategic decisions

Mentor and technically guide junior team members, fostering scientific rigor and development of analytical expertise

Drive best practices, standardization, and continuous improvement across analytical impurity platforms

Qualification

Analytical ChemistryImpurity CharacterizationRegulatory KnowledgeLNPMRNA ExpertiseMethod DevelopmentAdvanced Analytical TechniquesCross-Functional LeadershipTeam LeadershipMentorship

Required

PhD in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a related discipline with 8+ years of relevant industry experience (or MS with 12+ years)

Demonstrated experience developing and managing impurity characterization assays for complex biologics, nucleic acid therapeutics, or nanoparticle-based drug products

Strong working knowledge of LNP, mRNA, and/or oligonucleotide analytical characterization

Deep understanding of ICH guidelines, regulatory expectations, and CMC requirements for impurity control strategies

Proven ability to lead complex technical programs and effectively influence cross-functional stakeholders