Senior Manager/Associate Director, Antibody CMC

About Capstan Therapeutics

Capstan Therapeutics is developing a targeted delivery platform and therapeutics to reprogram immune cells in vivo in a scalable and controlled format, for a broad range of disease categories. The core technology originating from University of Pennsylvania comprises Targeted Lipid Nanoparticles (tLNPs) to enable off-the-shelf immunotherapies, with tight control of dosage and of activity of engineered cells. The objective is to advance transformative first-in-class and best-in-class products for oncology, fibrosis and inflammation-related diseases and blood monogenic disorders. Our dynamic start-up is founded by pioneers in the field of immunotherapy, regenerative medicine and drug delivery including experienced industry leaders and academic faculty members from U Penn.

In summary, Capstan Therapeutics aspires to become the leader of a new revolution in medicine, opening the avenue of in vivo reprogramming of the immune system and bringing this treatment modality to a broad range of medical needs. With locations in Philadelphia and San Diego, we are looking for talented individuals to join us.

The Opportunity

               We are seeking a subject matter expert responsible for oversight of initiation, development, scale-up, tech transfer and manufacture of antibodies and antibody fragments/variants to enable targeting of lipid-nanoparticles in support Capstan’s in vivo delivery platform. In addition, the technical lead will be expected to oversee the manufacture of batches for non-clinical safety studies and clinical studies under GMP for the antibody component. The candidate will work within a cross-functional product development team including Formulation Development, Process Development, Production, CMC, Regulatory Affairs, and Quality in all stages of development.

Responsibilities & Duties:

• The Senior Manager or Associate Director, Antibody CMC will be responsible for building our internal CMC capability) and for the management of external CDMOs under cGMP
• This role will be responsible for the delivery of robust, scalable, and cost-effective manufacturing
• This position will manage our external CDMO’s to ensure that all supply partners are following appropriate global regulatory standards
• Build internal CMC capability commensurate with the development stage of the company
• Contribute to novel approaches to conjugate antibodies/antibody fragments to lipid nanoparticles using standard and novel site-directed conjugation techniques
• Review and approve documents related to cGMP operations, including Tech Transfer, process and analytical development reports, qualifications, MBRs, and campaign summary report.
• Work closely with CMC and quality functions to lead quality investigations and data analysis to address deviations/ non-conformance and implement change controls to ensure timely/ prompt release of batches
• Prepare appropriate CTD sections for regulatory submissions.
• Development and monitor departmental goals and budgets.

Requirements/Qualifications:

• Pay range between $150k - 185k/year
• PhD. in Chemistry, Molecular Biology, Chemical or Bioengineering
• 5+ years post-Ph.D. experience in pharmaceutical or biotechnology companies
• Extensive experience working with protein therapeutics, antibodies, and conjugation chemistries
• Experience with process development, analytical characterization, process scale-up, and/ or regulatory descriptions of manufacturing processes/registration
• Experience with project management with external
• Experience with GxP/ GMP production
• Familiarity with quality by design, late-stage PD and process characterization preferred.

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 is an equal opportunity employer. We value diversity and do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform critical job functions, and to receive other benefits and privileges of employment.

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.