About our Company
Appia Bio is a preclinical stage biotech company founded in 2020 with the mission to bring innovative off-the-shelf cell therapies to cancer patients. Our novel platform can generate a broad array of allogeneic NKT and T cell types and can be engineered to address challenges in tumor microenvironments. Our goal is to discover and develop allogeneic cell therapies across a broad array of cancer indications with a scalability that increases access for patients.
Our research programs are rooted in leveraging T cell biology to generate NKT and T cell subtypes from hematopoietic stem cells. The scientific foundation of Appia Bio is underpinned by collaborative research led by Lili Yang (UCLA), David Baltimore (Caltech), and Pin Wang (USC), and further advised by a stellar scientific advisory board. The management team brings decades of experience in R&D, Technical Operations and business in the biotech industry.
About the Opportunity:
Appia Bio is seeking a highly motivated and exceptional process development professional to build and lead the Cell Therapy Process Design/Development group. This individual will provide strategic leadership in building out a process design group, developing innovative, robust, cost-effective and GMP-compliant manufacturing processes for company’s allogeneic cell therapy products. As a key member of Leadership Team, this managerial individual will play a leading role in creating strategies, influencing decisions, shaping core technology platforms and the advancement of therapeutic cell therapy candidates from research into the clinic.
- Lead the Cell Therapy Process Design/Development group, shape strategy, build capability, drive for operational excellence
- Serve as a member of Tech Ops Leadership Team, influence strategies and decisions on department goals and resource deployment
- Lead the design of function’s organizational structure, hire, mentor and manage a high-performing team of process engineers and associates, foster a spirit of teamwork, and help the staff grow technically and professionally
- Set strategic objectives, provide clear direction, and manage execution for the Process Design function to develop innovative, robust, cost-effective and GMP-compliant manufacturing processes
- Manage PD lab operations, identify novel manufacturing solutions, and champion the successful completion of development projects, ensure that development activities are aligned with the needs of research, manufacturing, analytical, quality, regulatory, clinical functions and external partners
- Author/Review regulatory submissions (IND, briefing packages, responses to questions), provide strategic and technical support for interactions with health authorities
- Identify opportunities, develop functional/technical capabilities for implementation of next generation PD and manufacturing platform to keep pace with advances in technology and company growth
- Develop and foster cooperative working relationships with other functions to advance therapeutic cell therapy candidates from research into the clinic
- PhD in Biochemical Engineering, Biomedical Engineering, Immunology, or a related discipline with 8+ years process development experience, 5+ years’ experience in leadership and people management
- Strong collaboration, communication, interpersonal and organizational skills, ability to thrive in a dynamic and cross-functional, fast-paced start-up biotech environment
- Organizational leader with experience managing a team of direct reports in process development for cell and gene therapy or biologics in early and late development setting
- Experience and knowledge in cell and gene therapy, specifically in hematopoietic stem cell or T cell
- Experience and knowledge in mammalian cell culture, process development, scale up and optimization in various bioreactors
- Knowledge of cGMP manufacturing and regulations and practical experience in GMP operations
- Experience authoring pertinent sections of regulatory submissions, experience leading process development in support of INDs and BLAs flings
Competitive Compensation Packages | Cost Sharing for Health Insurance Premiums | Flexible Work Environment | Untracked PTO | 401(k) Retirement Savings Plan Match | Life Insurance & Disability| Awesome Culture | Challenging & Fulfilling Work | Equity Options | and more
Appia Bio requires COVID-19 vaccination for all employees. As required by applicable law, we will consider requests for reasonable accommodations.
The statements herein are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.
Appia Bio is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.