|Title:||Head of Quality Control|
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.
The Head of Quality Control will provide managerial, technical, operational and strategic leadership in the development and implementation of all quality control and related activities. This will include team leadership, Quality control business process build out, methods transfer, feasibility assessment, qualification/validation and execution of multiple methods. The ideal candidate will oversee support phase appropriate critical quality attribute determination for all gene therapy assets, lead stability programs both in-house and at external contract laboratories. This role will require full collaboration with analytical development, manufacturing operations and Quality assurance, and CMC regulatory affairs teams. Fostering a quality and continuous improvement mindset to ensure that all QC deliverables are GMP compliant in a phase appropriate fashion to support all clinical programs.
In this role you will:
- Assist in the management and leadership of high performing QC functions.
- Management of Methods validations, transfer, testing and investigations for multiple gene therapy assets. This includes assessment and evaluation for QC fitness of newly transferred methods from analytical developments team as well as contract research organizations
- Close engagement with Analytical Development and Quality Assurance to build a sustainable GMP Quality Control platform to support growing portfolio of clinical development programs. This includes ensuring harmonized approach to method development that supports the transition and implementation of methods fit for commercial Quality control support.
- Assist in the oversight, selection and management of contract QC laboratories for multiple analytical assets. This includes technical due diligence, routine performance management and regular visits to ensure sustained quality analytical deliverables
- Support internal and external GMP manufacture and supply of high quality gene therapy products for clinical trials, including oversight of GMP sample handling, testing, QC stability program, QC release and stability data analyses and method data trending, out of specification investigations and Certificates of Analysis creation.
- Develop phase appropriate quality control capabilities, business processes, and procedures to ensure robust product supply, including establishment of appropriate processes for specifications setting and holistic control strategy
- Ensure that QC is aligned with all CMC stake holders, and in continuous collaborative state with analytical development, pharmaceutical Development, manufacturing, QA, regulatory affairs, clinical development, and program management, as well as with external vendors (CROs and CMOs), and Qualified/responsible Persons.
- Assist in team management and leadership, including team members and development plans.
- Establish continuous learning and improvement programs for QC, thereby ensuring all team members are engaged and passionate about their work.
- Promote a company-wide culture of safety, quality and responsible mindset. This is includes having appropriate metrics and community ownership of these key cultural traits
- BA/BS, MS or PhD in a Biochemistry/Molecular Biology/Pharmaceutical Sciences or other relevant scientific field of study with 10-15 years of relevant experience working in Quality Control and/or Analytical Development with GMP experience in the Pharmaceutical/ biotechnology industry
- Must have large molecule / biologics experience to be considered for the role
- In-depth technical and regulatory understanding of biologics or gene therapy QC and understanding of holistic control strategy for Biological/gene therapy therapeutic entities as well as applicable international regulations and standards in all phases of clinical development. Good understanding and experience of GT manufacturing sciences and processes.
- Proven leadership experience and people management skills with the desire and ability to work in a fast-paced rare and company
- Strong collaboration, team-building, and organizational skills are required
- Established experience working with and management of third party contractors and vendors.
- Excellent written and verbal communication skills.
- Travel as needed
- 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