Senior Director, Cell Therapy Process Development
Job Code: 2022 CT002
Immunomic Therapeutics, Inc. (ITI), a privately held, pre-IPO clinical-stage biotechnology company pioneering the study of LAMP-mediated nucleic acid-based immunotherapy using UNITE™. Powered by LAMP (Lysosomal Associated Membrane Protein), ITI’s UNITE platform is designed to utilize the body’s natural biochemistry to develop vaccines that have the potential to generate broad immune responses. The UNITE™ platform has a robust history of applications in various therapeutic areas, including infectious diseases, oncology, allergy, and autoimmune diseases. ITI is primarily focused on applying the UNITE platform in oncology, where it could potentially have broad applications, including antigen-derived antibodies as biologics. The company has built a pipeline of four wholly owned oncology programs, the lead of which is in a Phase 2 clinical study for Glioblastoma Multiforme (GBM).
The incumbent will engage with both internal and external partners to lead Cell Therapy Process Development including preclinical, clinical stage, and commercialization of cell and gene therapy products. This position requires a strategic leader with experience in cell biology and/or immunology with a record of prior achievement in the development and manufacturing of large molecule biologics, cell and/or gene therapy products. This position reports to the Vice President, Operations
Provide technical leadership of cell therapy process development, technology transfer and related cGMP manufacturing activities including process validation. Lead the development and technology transfer of cell therapy manufacturing and testing processes.
Drive continuous improvement activities. Evaluate new technologies and innovate novel approaches to improve existing methods. Provide oversight of internal and external development projects and influence cross-functional partners to support process development objectives.
Manage project timelines/scheduling and lead engagement with internal and external partners, including external contract development/testing laboratories. Track achievement of objectives and successes, identify risks and mitigation strategies, and implement rapid corrective action.
Establish the product characterization, lot release and stability testing panels.
Author/review/approve technical documents (SOPs, protocols, reports, risk assessments, specifications, etc.). Author and review technical and regulatory documents in support of CMC regulatory submissions (IND, BLA, etc.).
Attract and retain skilled talent and mentor/train/encourage a team-centric environment with opportunities for skill development and personal growth.
Work to build a positive culture with key internal team members, stakeholders, and external customers.
Engage with both internal and external partners in the support of Process Development, preclinical, and clinical development of cell and gene therapies.
Competencies and Skills
Communication/Presentation Skills (spoken, written)
Sense of Urgency
Required Education and Experience
Advanced degree in cellular biology, biochemistry, immunology or related field (PhD preferred,) and appropriate years of experience.
PhD and 12 years of work experience; MS and 14 years of work experience
In-depth understanding of cellular biology and immunology with application to development of cellular processing and analytical methods.
Familiarity with all phases of the method development lifecycle (development, optimization, qualification, validation, method transfer).
Familiarity with the following: flow cytometry/FACS, ELISpot, ELISA, cell culture/cell-based bioassays, microscopy. Prior experience developing potency and/or immunophenotyping test methods for cellular therapies.
Experience leading process development organizations and supporting external manufacturing.
Understanding of global regulatory requirements (FDA, EMA, ICH) for bioassay/potency, analytical method validation, comparability, and drug product stability.
Competency in the application of statistical methods and tools for data analysis.
Demonstrated leadership and critical thinking skills, and ability to motivate, manage, and influence team members with direct and indirect reporting status as part of CMC product development.
Ability to work independently or as a team member to meet goals and commitments.
Strong written and verbal communication skills are required. Experience translating complex scientific concepts and data into reports, presentations and CMC filings is required.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
Please visit our careers site at http://www.immunomix.com/careers/. Send your cover letter and credentials as described on the Careers page along with the Job Code: 2022 CT002 in the subject line.
Equal Opportunity Employer