Process Development Engineer - Military veterans preferred

2021-05-03
Appia Bio
Other

/yr

  full-time   part-time   employee   contract


Los Angeles
California
90101
United States

POSITION: Engineer in Cell Therapy Process Design; Associate to Director levelLOCATION: Los Angeles, CAREPORTING RELATIONSHIP: Reports to SVP of Technical OperationsCOMPANY OVERVIEWAppia Bio is a new biotech company with the mission to bring innovative cell therapies to more patients. Our novel platform can create a broad array of allogeneic NKT and T cell types, and can be further engineered to address challenges specific to 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 preclinical programs involve the lineage determination of hematopoietic stem cells into NKT and T cell subtypes via lentiviral programming. The scientific foundation of Appia Bio is underpinned by collaborative research led by Lili Yang (UCLA), David Baltimore (Caltech), and Pin Wang (USC). The founding management team brings broad experience in cell therapy development and company creation.POSITION SUMMARY Appia Bio is seeking a highly motivated process development professional to join the Cell Therapy Process Design group. This individual will provide subject matter expertise in leading the development of innovative, robust, cost-effective, and GMP compliance manufacturing processes. This individual will work with other cross-functional groups to translate R&D findings into manufacturable processes, support tech transfers, regulatory filings, and GMP manufacturing to advance Company’s allogeneic cell therapy products for cancer treatment.Responsibilities  ·       Contribute to process design team to develop, optimize, scale up and tech transfer GMP compliance manufacturing processes to meet project timelines and company goals·       Drive continuous improvement in process development through technological innovation and alignment with regulatory and manufacturing requirements ·       Prepare, review, and approve experimental proposals, technical reports, SOPs, batch records and other documentations·       Manage and participate in tech transfer of manufacturing processes, provide SME support to manufacturing function or external partners·       Work collaboratively within PD group and cross-functionally with other groups to meet Tech Ops organizational goals·       Support preparation of CMC sections of regulatory submissions and provide technical support for interactions with health authorities ·       Bring subject matter expertise and leadership to a diverse team in process development and foster a spirit of teamwork, and help the staff grow technically and professionally·       Identify opportunities, develops functional/technical capabilities for implementation of next generation PD and manufacturing platform to keep pace with advances in technology and company growth ?Qualifications·       Advanced degree (PhD highly preferred for senior levels) in Biochemical Engineering, Biomedical Engineering, Stem Cell Biology, Immunology, or a related discipline with industry process development or manufacturing experience. BS/BA educational background in similar fields sufficient for Associate level.·       Hand-on experience in cell and gene therapy, specifically in hematopoietic stem cell or T cell is highly desirable ·       Experience in technical development of cell and gene therapy or biologics in early and late development setting ·       Knowledge of cGMP manufacturing and regulations and practical experience in GMP operations is highly desirable·       Knowledge of QbD, DOE and appropriate statistical analyses for process development ·       Strong collaboration, communication, organizational skills, ability to thrive in a dynamic and cross-functional, fast-paced start-up biotech environment