What are the responsibilities and job description for the Quality Control Technician position at Cellphire Therapeutics, Inc.?
Who We Are
Cellphire Therapeutics, Inc. is a Rockville, Maryland-based biotechnology company developing next-generation therapeutics. The company is applying its proprietary cell stabilization technology to all cell types, including platelets, to develop lifesaving products. Its lead product, Thrombosomes®, a freeze-dried hemostatic agent derived from human platelets, is currently in a Phase I clinical trial. Cellphire’s technology has potential applications across a wide range of medical applications from trauma to wound care, imaging, targeted drug delivery, and regenerative medicine. www.cellphire.com
Benefits That Matter
- Competitive base salary bonus
- Equity opportunities
- Comprehensive medical, dental, and vision
- 401(k) with company match
- Generous PTO and holidays
Position Overview
The Quality Control Technician performs laboratory testing to ensure Cellphire products meet quality, safety, and regulatory standards. This role supports product release activities through accurate testing, documentation, and data review. The technician collaborates with Manufacturing and Quality teams to resolve quality issues and maintain compliance. Success in this position requires strong attention to detail, technical aptitude, and a commitment to quality.
What You Will Do
- Perform routine quality control testing of cell therapy products, raw materials, and in-process samples in accordance with established SOPs and GMP regulations
- Execute laboratory assays including, but not limited to, flow cytometry, cell counts, sterility testing, endotoxin testing, and viability assays
- Accurately document test results, deviations, and observations in laboratory notebooks and electronic systems
- Review and verify data for accuracy, completeness, and compliance with internal and regulatory standards
- Maintain and calibrate laboratory equipment and instrumentation
- Assist in investigation of out-of-specification (OOS) results and implement corrective actions as required
- Support method validation, transfer, and qualification activities
- Ensure compliance with FDA, cGMP, and applicable regulatory requirements
- Participate in internal and external audits as needed
- Maintain a clean, organized, and compliant laboratory environment
- Collaborate cross-functionally with Manufacturing, Quality Assurance, and R&D teams
- Adhere to all safety protocols and company policies
Ideally, you’ll have
- Associate’s or Bachelor’s degree in Biology, Chemistry, Biotechnology, or a related scientific field
- 1–3 years of experience in a GMP-regulated laboratory environment preferred
- Experience with cell therapy, biologics, or pharmaceutical quality control strongly preferred
- Familiarity with aseptic techniques and microbiological testing methods
- Strong knowledge of cGMP, GDP (Good Documentation Practices), and regulatory standards
- Excellent attention to detail and organizational skills
- Ability to accurately record and analyze data
- Strong written and verbal communication skills
- Ability to work independently and within a team environment
- Proficiency with laboratory software systems and Microsoft Office applications
Pay Range USD $45,000.00- USD $75,000.00 /Yr.
Disclaimer: Please note that job responsibilities, reporting lines, and duties outlined in this job description are subject to change to meet the evolving needs of the organization.
Cellphire is an Equal Opportunity Employer.
Thrombosomes® has not been approved or licensed by the U.S. Food and Drug Administration (FDA) but has been authorized for emergency use under an Emergency Use Authorization (EUA). The product is authorized only for the duration of the declaration that circumstances exist justifying the authorization of emergency use.
Salary : $45,000 - $75,000