- Job Type: Full-Time
- Function: Life Sciences QA/QC
- Industry: Oncology
- Post Date: 12/04/2023
- Website: www.capstantx.com
- Company Address: 9880 Campus Point Drive Suites 130/220, San Diego, CA
About Capstan TherapeuticsA platform for creating in vivo-engineered cell therapies in oncology and inflammatory disease
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.
We are seeking a highly motivated Director of Quality Assurance to ensure that quality activities conducted internally and on behalf of the company follow applicable US/international laws and drug development regulations for compliance with GXPs (GMP, GLP, GCP). This role will operate from our San Diego office and provide key oversight of the quality management system (QMS) and serve as the quality representative in the day-to-day quality operations for the company’s clinical drug candidates.
Responsibilities & Duties:
- Develop and oversee a phase appropriate QMS including the writing and reviewing of standard operating procedures (SOPs), templates, and forms to support the company’s functional groups with GMP, GLP, and GCP activities.
- Establish a training program for the QMS that includes creating a training matrix, conducting SOP training, and documenting external and GXP knowledge training.
- Represent the quality viewpoint in meetings with internal teams and GXP vendors; provide continued oversight/monitoring of GXP activities.
- Manage the GXP vendor qualification process as the quality point of contact with the provision of questionnaires, coordination of audits, and reporting of findings to internal stakeholders.
- Spearhead process for putting in place quality agreements with GXP vendors.
- Review batch records, method validations, and vendor quality events (deviations, investigations, change control, corrective and preventive actions).
- Implement and maintain a system to track the GMP batch release of clinical trial materials and expiry dating.
- Bachelor’s degree (or equivalent) and 10 years related experience, including 4 years of experience managing people and/or a functional area.
- Knowledge of the drug and biologic development process.
- Excellent communication and interpersonal skills.
- Ability to work with internal and external teams for planning of development activities and resolution of quality issues.
- Capable of working in a startup environment with the ability to multi-task, prioritize, and execute with minimal guidance.
- Experience with cell therapy and/or lipid nanoparticle formulations is a plus.
- $200,000 – $220,000/year + performance bonus & equity
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