Associate Director, Quality Assurance - Capstan Therapeutics
San Diego, CA 92121
About the Job
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 are seeking a highly motivated Associate 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 support for the development and maintenance of the quality management system (QMS) with emphasis on documentation.
Responsibilities & Duties:
- Oversee the standard operating procedures (SOPs) process including authoring and approval with internal team members.
- Execute the QMS training program including keeping a current training matrix, conducting SOP training, and documenting external and GXP knowledge training.
- Assist in review of GXP documentation including manufacturing records, method validations, vendor quality events (deviations, investigations, change control, corrective and preventive actions), and nonclinical reports.
- Conduct source verification for data from internal development studies.
- Provide support for general QMS activities including audits, vendor management, and document control.
- Implement and maintain a system to track the GMP batch documentation for release of clinical trial materials and expiry dating.
- Maintain a system to track GXP quality issues.
- Provide quality guidance in internal and external team meetings and correspondence with manufacturing, operations, and other functional areas.
- Generally met with a bachelor’s degree (or equivalent) and 8 years related experience, including 3 years of experience managing a functional area.
- Bachelor’s in a scientific related field preferred
- Knowledge of GMP, GLP, and GCP.
- Previous experience with biologics a plus.
- Organized with sharp attention to detail.
- Capable of working in a startup environment with the ability to multi-task, prioritize, and execute with minimal guidance.
- Strong oral and written communication skills.
- Salary range is $185,000 - $195,000/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
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.
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