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. Sycona 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.

The Opportunity

We are seeking a collaborative and highly technically motivated Scientist with multi-disciplinary vector, cell line and cell culture process development expertise to join our process development group. This position is hands-on and a potential leadership opportunity. The individual will be responsible for gene vector, producer cell line and mammalian cell culture activities associated with the conceptualization and development of upstream operations for manufacturing of sterile injectable AAV-based gene therapy drug products.

The scope includes all aspects of upstream development (vector, cell line and process) efforts with focus on the manufacturing of AAV-based gene therapies including scientific principles and underlying concepts and methodology of mammalian cell culture (adherent and suspension), transient transduction, viral vector expression and isolation.

Key Responsibilities

• Design and conduct small-scale cell culture experiments including scale-down bioreactor to develop and validate scale-down process model supporting production-scale bioreactor optimization;
• Develop and conduct experimental approaches including design of experiments (DOEs) for vector design, producer cell line development, media optimization, pre-culture conditions, seed train strategy and critical process parameters (CPPs) and key performance indicators (KPIs) of the production bioreactor in the development and confirmation of upstream process operations for new products;
• Collaborate with other functional groups including research and analytical development teams for screening and characterization studies; familiarity with titer assay development including primer design, DNA isolation/purification and PCR quantification using data analysis packages highly desirable;
• Support and assist in technology transfer activities and oversight at CDMOs/CROs;
• Overall and importantly, as part of the Upstream Team you will: (i) contribute to Team efforts to apply engineering control concepts to efficient process attribute screening, optimization and scale-up of mammalian cell culture systems; (ii) establish robust, scalable, and productive upstream cell culture processes; and (iii) establishment of platform-based expression and isolation operations for AAV-based vector therapeutics.
• Author, review and provide technical support to the establishment and continuous improvement of manufacturing SOPs and batch production records;
• Mentor associate scientists and research associates;

Basic Requirements:

• PhD in chemical, biochemical engineering, cellular & molecular biology or related life sciences and at least 8 years of work experience in a cell and/or gene therapy research/development environment;
• Exceptional non-PhDs with demonstrated capabilities and/or significant experience may also be considered;
• Knowledge in broader scientific principles and underlying concepts of cell culture including vector and cell line development as well as upstream process development for gene therapy or viral vaccine drug candidates, both internally (pilot plant) and externally (CDMOs) highly desirable;
• Demonstrated success and accomplishment in scientific creativity; sound judgment and problem-solving capabilities;
• Ability to collaborate with others while maintaining a strong capability in independent, critical thought;
• Must be able to clearly communicate scientific information in both written and oral settings;
• Strong organizational skills are required and must be able to work as part of a team;
• Experience working in an FDA regulated environment and knowledge of current GMPs as they apply to quality control laboratory practices are highly desired;
• Ability to travel (10% travel time).

  Skills

• Strong interpersonal and organizational skills.
• Excellent writing and verbal communication skills.
• Excellent problem solving ability
• Ability to multitask.
• Strong collaboration and team-working skills
• Possess a mind set of no job to 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