|Title:||Director of Manufacturing – AAV Gene Therapy|
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.
We are seeking a collaborative and experienced manager to lead external manufacturing and supply operations within technical operations. This leadership role with opportunity for growth will lead process engineers and be responsible for technical oversight of CDMOs. Additionally, this role also builds and oversees the supply chain and operations function to ensure final distribution of drug product to clinical sites.
In this role you will:
- Build and manage team of process engineers to support external manufacturing
- Build efficient supply chain operations, including purchasing and inventory of raw materials, selection of vendors, supply and demand planning, and support distribution of final product to clinical sites
- Ensure routine support of the CDMOs for deviation management, batch record reviews to maintain reliable supply
- Participate in the appropriate internal and joint CDMO governance meetings
- Collaborate with Process Development, Analytical Dev, Quality Operations, Facilities, and other personnel to achieve common goals
- BS or advanced Biological Science, Biomedical Engineering, Chemical Engineering, or related discipline with 5 -10 years of experience for manufacturing experience in biologics, vaccines or gene therapy
- Established track record of success, sound technical qualifications and knowledge in process and analytical transfers. Cell therapy development or related field, aseptic manufacturing, and validation experience a plus.
- Established experience with tech transfer to multiple CDMOs is a plus
- Excellent cross-functional and collaboration skills including work with accountability to multiple stakeholders.
- Strategic thinker with excellent problem solving and conflict resolution skills.
- Prior process development experience is a plus
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