About SwanBio Therapeutics

SwanBio is a privately held, 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.

The Opportunity

This role will assist the head of QC to establish systems and processes to support cGMP testing. This individual will be a critical part of the growth of the cGMP capabilities at SwanBio The role will also provide support for cGMP testing. In addition, this role will manage multiple projects in a fast-moving and results-oriented environment.

Key Responsibilities

In this role you will:

• Perform QC analytical testing in support of the GMP manufacturing schedule .
• Works to maintain and continuously improve QC laboratory controls.
• Manages day to day work in the QC Lab, including assignments of testing schedules
• Works to establish and maintain GMP Quality Systems through SOP creation/review as focused in the Quality Control Laboratory
• Analyzes and formats data to support method evaluation and trending.
• Performs analytical data review to ensure data integrity and adherence to standard operating procedures and cGMPs
• Works with AD to execute method qualifications/validations including test method transfer activities
• Leads laboratory investigations and provides SME oversight to the content of investigation reports.
• Leads CAPA and change controls as necessary.
• Applies expertise to support change and risk management, including application of scientific and technical innovation.
• Actively participates in equipment and instrument purchase, qualification, calibration, and preventive maintenance
• Interacts with other functions on a technical level for various projects.
• Provides input to troubleshoot manufacturing complications in collaboration with Analytical Sciences, Manufacturing Sciences and Operations
• Communicates, supports, and meets corporate and site goals and objectives
• Prepares presentations for senior management to provide updates and facilitate decision-making.
• Design, execute and analyze experiments in support of Bioassay and Cell-based Assay method development/optimization.
• Draft method-specific development reports and SOPs.
• Optimize, qualify, monitor performance and maintain inventory of Critical Reagents
• Testing QC reagents and samples
• Participate in Bioassay and Cell-based method qualification/validation and method transfer studies.
• Provide support to complex QC investigations through experimental design, data mining and analysis, problem solving and technical writing.
• Trend, analyze and report method and Critical Reagent performance data, alert and advise management on issues.
• Write and revise Quality Control Methods
• Manage the stability Program

Basic Requirements:

• BS or MS degree in the biological, biochemical or related sciences with generally 5 years of experience in the Bio/Pharmaceutical industry
• Experience in development and optimization of ELISAs and cell-based assays
• Experience in the design and optimization of potency and infectivity assays for AAV gene therapy products preferred
• Working knowledge of molecular-based (PCR) assays
• Prior experience working in GMP environment is required
• Experience using Quality System processes, and functional knowledge of Quality and Compliance is required
• Experience working with CMOs/external partners

 Skills:

• Strong scientific and laboratory skills
• Ability to resolve and advise on technical issues
• Detail oriented and well-organized
• Effective written and oral communication skills
• Strong collaboration skills
• Ability to work efficiently in a GMP environment
• Flexible, and comfortable with a fast-paced and evolving business environment
• Identify, resolve, and/or advise on technical issues
• Possess the mind-set of no job too big or too small

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