About SwanBio Therapeutics

SwanBio is a privately held, newly established biotechnology company focused on the discovery and development of innovative gene therapy products for the treatment of central nervous system (CNS) disorders and diseases. SwanBio has a deeply experienced leadership team and is building an open, innovative culture that trusts its people, processes and science to deliver scientific, clinical and business success.SwanBio’s lead investor is Syncona, a premiere investment partner focused on building companies delivering transformational healthcare treatments. Syncona has a deep pool of capital and they are established leaders in the development of genetic medicine. In particular, they present a legacy of success in long term investment strategies for companies in the Gene and Cell Therapy space. Our goal is to become a world-leader in treating neurodegenerative diseases. With locations in Philadelphia and Boston, the SwanBio Team is building a strong pipeline of gene therapy development programs with a directed focus on critical unmet medical needs for CNS diseases. SwanBio offers all team members both competitive compensation and benefits.

Key Responsibilities

• Assist in the planning and conducting of audits in support of external manufacturing and testing to ensure health authority regulations and guidelines
• Oversee and manage of GMP/GLP inspections
• Assist in the development of corrective and preventive actions when appropriate and ensure effective reporting mechanisms are developed and followed
• Establish performance criteria, monitor results, coach and develop knowledge and competencies of team members involved in GMP/GLP
• Establish, maintain and monitor CMO/CRO relationships including initial selection
• Conduct GMP audits or followed participate in other quality assurance work
• Maintain knowledge of current quality and GMP/GLP practices, literature and applicable professional regulations and theories in field of expertise
• Assist in the development, maintain and oversee QMS system as well as providing training to team members on the system.
• Manage the development, execution, review, and/or approval process of all controlled documents, including SOPs, deviations, investigations, change requests, CAPAs.
• Review and approve validation and stability protocols/reports
• Perform batch record review and product release
• Ensure the internal quality management system to support external manufacturing is developed and maintained
• Develop and implement GxP improvement projects for systems and procedures including SOPs, policies, forms, and tools
• Identify and communicate quality or compliance risks and participate in establishment of appropriate plans to address the risks
• Schedule, plan and perform CMO, CRO and/or laboratory audits
• Ensure all deviations/change controls from established procedures are appropriately documented and investigated to determine and address root cause.

Basic Requirements:

• BS in Chemistry, Chemical Sciences, Biochemistry or equivalent education and experience
• Minimum 3-5 years of biopharmaceutical experience, including 3 years in a quality/regulatory function required
• Must have experience working with large molecules, gene therapy experience a plus

Skills

• Strong analytical development skills
• Practical knowledge of how to identify key performance quality metrics
• Experience with developing relationships
• Ability to work under challenging deadlines and be accountable for completing work within specific project timelines
• Strong detail orientation, organization and focus on quality work product
• Proficient in MS Office Suite
• Proven ability to establish new quality systems and optimize existing systems, review documentation, processes and procedures, identify issues, assess compliance, communicate findings clearly and succinctly
• Excellent verbal and written communication skills

About the Benefits:

The successful candidate will enjoy a competitive base salary and the opportunity to participate in incentive compensation programs including bonus and stock option plans. Additionally, SwanBio Therapeutics offers all team members a comprehensive benefits program including medical, dental, vision care, 401(k), paid vacation and holiday time.

SwanBio Therapeutics is an equal opportunity employer