Director Analytical Development
Director Analytical Development
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USD 190000 - 225000
1 Vacancy
Job Description
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. Capstans 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 fastpaced and collaborative team. This position will be primarily responsible for establishing and managing analytical strategies supporting the biophysical characterization and development of mRNAbased targeted lipid nanoparticles (tLNPs) for Capstans 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 phaseappropriate 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 LCMS CE iCIEF DLS ELISA and platebased assays.
Lead phaseappropriate buildout of analytical methods for extended characterization product release stability comparability and compatibility.
Oversee inprocess analytics process optimization and new technology development activities
Manage internal routine nonroutine 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 612 scientists and associates
Requirements/Qualifications:
Generally met with a PhD with 10 years related experience including at least 35 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 adhoc testing
Demonstrated familiarity with international regulatory standards and application to phaseappropriate 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 teamdriven 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 onsite meals.
Fun team environment with many employee events throughout the year
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 forour 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 Californias 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 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.
Required Experience:
Senior IC
Employment Type
Full-Time
