Why Spur?
Gene therapy is at an inflection point. Amidst the noise of countless emerging modalities, we've been hard at work refining our science and advancing our programs with quiet determination and a bold ambition to unlock the true potential of gene therapy to change the trajectory of more patients' lives. Come join Spur's dedicated team of scientists, physicians and other professionals who are singularly focused on using cutting-edge science and technology to transform the treatment of serious and debilitating chronic diseases.
What We Are Trying To Accomplish
We are a clinical-stage biotech company developing transformative adeno-associated virus (AAV) vector-mediated gene therapies. Founded in 2015, Spur is focused on developing innovative, one-time treatments that set new standards of care by optimizing every component of our product candidates to develop first- and best-in-class gene therapies. We are currently advancing a highly differentiated gene therapy candidate into a Phase 3 clinical trial in people with Gaucher disease and a preclinical gene therapy program for Parkinson’s disease. Spur is global, with offices in Stevenage, UK, as well as operations in Boston and New York.
How Will We Do It
We are relentless in our pursuit of transformative medicines for patients. We take innovation seriously and know we need to be bold both in our science and in every aspect of our work. We also know we can only achieve these things together, so we act as one Spur and expect that of each colleague in the company. We always do the right thing – the trust of patients and their caregivers is critical to our success. If you have an entrepreneurial mindset, are willing to work hard to transform the lives of patients, and share our values, then Spur could be the place for you.
Role Purpose
The Quality Assurance Specialist is responsible for supporting Quality Systems and GMP compliance activities within a biological manufacturing environment. This role provides quality oversight of manufacturing operations, batch record review, investigations, change controls, disposition package, and regulatory compliance activities associated with clinical and commercial biological products.
The Quality Assurance Specialist will collaborate closely with Manufacturing, Quality Control, Regulatory Affairs, and Technical Operations to ensure products are manufactured in compliance with current Good Manufacturing Practices, regulatory requirements and internal requirements.
Responsibilities
- Perform detailed review of executed batch production records and all associated manufacturing documentation for completeness, accuracy, and compliance.
- Verify manufacturing activities were performed according to approved procedures, batch records, and regulatory requirements.
- Identify and resolve documentation discrepancies in collaboration with manufacturing partners and technical operations.
- Support activities associated with raw materials, intermediates, drug substances, and drug product lots.
- Compile the batch disposition package.
- Lead and support quality event and deviation investigations. Conduct root cause analyses.
- Compile manufacturing information and metrics to support annual product review reporting.
- Perform product complaint investigations with CDMO partner.
- Monitor CAPA effectiveness and ensure timely closure of quality events.
- Support administration and maintenance of Quality Management System (QMS) processes within Spur’s eQMS including SOPs, Training, and change controls.
- Review and approve quality documentation to ensure compliance with internal procedures and regulatory requirements.
- Ensure manufacturing operations comply with applicable FDA, EMA, ICH and other regulatory requirements.
- Support preparation, review, and maintenance of quality documentation for IND and BLA submissions.
- Participate in regulatory inspections and partner audits, including preparation, response development, and follow-up activities.
- Review and approve SOPs, protocols, and reports.
- Provide quality guidance and training to Spur personnel.
Qualification & Experience Required
- Minimum of Bachelor’s degree in Biology, Microbiology, Biochemistry, Pharmaceutical Sciences, Engineering, or related scientific discipline.
- Minimum 5 years Quality Assurance experience in biologics, cell therapy, gene therapy, vaccine or related GMP manufacturing environments.
- Experience with aseptic processing, contamination control and mitigation, and packaging preferred.
- Experience working with external providers including CDMOs, Contract Test facilities, and third-party supply chain is preferred.
- Basic understanding of global regulatory guidelines and requirements.
- Strong negotiation, communication, and problem-solving skills. Excellent attention to detail and documentation review skills.
- Proficiency with Microsoft Office applications and electronic quality systems.
- Strong organizational and project management capabilities.