Director, Analytical Development

About Capstan Therapeutics
Capstan Therapeutics is a biotechnology company with a mission to multiply the therapeutic possibilities for patients by developing targeted in vivo RNA technologies. Our proprietary CellSeeker™ tLNP platform technology is composed of novel 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. Capstan’s CellSeeker™ technology has the potential to generate transformative therapies with possible applications across a broad range of disease areas, including autoimmune disorders, oncology, fibrosis, and monogenic blood disorders.

The Opportunity
We seek a 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, lead product investigations, and guide phase-appropriate development and refinement of QC and extended characterization methods. 

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.
•    Oversee in-process analytics, process optimization, and new technology development activities
•    Manage internal routine, non-routine, and stability testing of lipid, mRNA, antibody, antibody conjugates, and targeted LNP drug products
•    Guide assay development from optimization through validation. Support method transfer and troubleshooting with external CROs/CDMOs
•    Lead analytical investigations into deviations and OOS results
•    Draft technical reports and analytical sections for regulatory filings
•    Manage and develop a team of 6-12 scientists and associates


Requirements/Qualifications:
•    Generally met with a PhD with 10+ years related experience, including at least 3-5 years of experience managing direct reports and/or a functional area
•    Degree in Biochemistry, Chemistry, Bioengineering, Chemical Engineering or related field with proven technical and leadership track record developing analytical methods for biologics (LNPs, mRNA, viral vectors, antibodies, etc) is required
•    Deep technical expertise for applying current analytical methodologies for lipid excipients, antibodies, mRNA, and targeted LNP therapeutics
•    Demonstrated operational excellence building and managing integrated workflows for routine and ad-hoc testing
•    Demonstrated familiarity with international regulatory standards and application to phase-appropriate analytical development and strategy. 
•    Experience designing and executing stability, comparability, and compatibility studies to ensure product integrity and efficacy is strongly preferred.
•    Experience with method transfer, qualification, and validation with CROs/CDMOs is strongly preferred
•    Strong proficiency composing technical reports and analytical sections for 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:
•    Salary range is $190k – $225k depending upon experience
•    Performance bonus
•    Employee Stock Option Program
•    401(k) Program including an employer matching contribution 
•    Medical coverage
•    Dental coverage
•    Vision coverage
•    Short and Long Term Disability coverage
•    Flexible Spending Account (FSA)
•    Optional Dependent Care Account
•    Paid Time Off (PTO)
•    Company Paid Holidays
•    Paid Sick Days
•    Employee Assistance Program
•    Onsite Fully Stocked Kitchens
•    Alexandria Real Estate Tenant, perks include gym and fitness class access, discounts at affiliated restaurants, and frequent on-site meals. 
•    Fun team environment with many employee events throughout the year

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If you are interested in hearing more, reach out to us. We believe that each team member will impact and improve the lives of those we work with, and those we work for—our patients.

Capstan Therapeutics, Inc. is an equal opportunity employer and does not discriminate against applicants or employees on the basis of race, religion, creed, color, ancestry, national origin, sex, gender (including pregnancy, childbirth, breastfeeding or related medical conditions), gender identity, gender expression, sexual orientation, age, marital status, military or veteran status, medical condition, disability, genetic information, or any other characteristic protected by applicable federal, state or local laws.

In accordance with the Americans with Disabilities Act, California's Fair Employment and Housing Act, and applicable local law, applicants and employees with disabilities are eligible for and may request reasonable accommodations to participate in the job application or interview process and to perform the essential functions of the job, unless such accommodation constitutes an undue hardship. Please contact careers@capstantx.com if you need assistance completing any forms or to otherwise participate in the application process.

Unsolicited resumes sent to Capstan from recruiters do not constitute any type of relationship between the recruiter and Capstan and do not obligate Capstan to pay fees should we hire from those resumes. We ask that external recruiters and/or agencies not contact or present candidates directly to our hiring managers or employees.