Associate Director, Analytical Development

About Capstan Therapeutics
Capstan Therapeutics, Inc. is a privately held biotechnology company dedicated to advancing in vivo cell reprogramming. The core platform technology comprises proprietary targeted lipid nanoparticles (tLNPs) that are composed of LNPs conjugated with a recombinant protein binder, such as a monoclonal antibody. tLNPs are designed to deliver payloads, including mRNA or gene editing tools, capable of reprogramming specific cell types in vivo. The platform technology has the potential to generate transformative therapies with possible applications across a broad range of disease areas, including oncology, autoimmune disorders, fibrosis, and monogenic blood disorders.
The Opportunity
We seek an Associate Director of Analytical Development to join an experienced, fast-paced and collaborative team. This position will be primarily responsible for establishing and managing analytical strategies supporting the biophysical characterization and development of mRNA-based targeted lipid nanoparticles (tLNPs) for Capstan’s pipeline. Working closely with the technology development and research teams, this position will drive process/product understanding, support expansion of the tLNP platform, and lead product investigations.
Responsibilities & Duties:

• Lead internal development of novel analytical methods to characterize tLNP components and product, including HPLC, LC-MS, CE, iCIEF, DLS, ELISA, and plate-based assays.
• Lead phase-appropriate buildout of analytical methods for extended characterization, product release, stability, comparability, and compatibility.
• Support in-process analytics, process optimization, and new technology development activities
• Manage internal routine and non-routine analysis of lipid, mRNA, antibody, antibody conjugates, and targeted LNP drug products
• Support internal stability programs
• Support method transfer to external CDMOs
• Lead analytical investigations into deviations and OOS results
• Draft technical reports and analytical sections for regulatory filings
• Manage and develop a team of 5-10 scientists and associates

Requirements/Qualifications:

• Generally met with a bachelor’s degree (or equivalent) and 8 years related experience, including 3 years of experience managing direct reports and/or a functional area
• Degree in Biochemistry, Chemistry, Bioengineering, or related field with proven technical and leadership track record developing analytical methods for biologicals (LNPs, mRNA, viral vectors, antibodies, etc) is strongly preferred.
• Deep technical expertise in the application of current analytical methods for the characterization of lipid excipients, antibodies, mRNA, and targeted LNP therapeutics.
• Demonstrated familiarity with international regulatory standards and application to analytical methodologies.
• Proven involvement in stability programs to ensure product integrity and efficacy.
• Strong proficiency composing comprehensive reports and analytical sections for submission in regulatory documents such as IND/IMPD, BLA/MAA, with a marked preference for candidates possessing this experience.
• Exceptional communication skills, both written and verbal, with a demonstrated capacity to thrive in collaborative, team-driven environments.

Salary & Benefits Offerings:

• Salary range is $180,000 - $200,000/year depending on experience.
• Performance bonus & Equity
• 401k Match Program
• Healthcare Coverage
• Dental Coverage
• Vision Coverage
• Optional Dependent Care Account
• Flexible Spending Account (FSA)
• Paid Time Off (PTO)
• Company Paid Holidays
• Paid Sick Leave
• Onsite Fully Stocked Kitchens