Associate Director/Director, Process Development



ImmPACT Bio is a clinical-stage company, headquartered in the Los Angeles area, and with a subsidiary in Israel, developing novel cell therapies for treating cancer. The company’s next-generation chimeric antigen receptor (CAR)-T cell technologies are based on Boolean logic-gate approaches and address key biological challenges for engineered T cell therapies including relapse due to antigen loss/escape; on-target, off-tumor toxicities; and the immunosuppressive tumor microenvironment.


ImmPACT’s lead program, a bispecific “OR-gate” CAR, with an excellent tolerability profile, has demonstrated durable complete remission (CR) in 88% of patients treated so far.


ImmPACT Bio provides a generous rewards package, with competitive compensation and health benefits, with career progression benefits as part of a rapidly growing multi-platform company.


ImmPACT Bio is seeking for an exceptional individual to join our growing team as Associate Director/Director, Process Development to help build and lead process development function in support of ImmPACT Bio’s cell therapy portfolio. The successful candidate will lead the scientific, technical and operational efforts required to support development and optimization of cell therapy processes and will be responsible for assisting with the authorship of the CMC section of multiple INDs. This position requires strong interpersonal skills, effective management skills, strong analytical technical skills and collaborative team leadership abilities. This position will report directly to the Head of Process Sciences.


Primary Responsibilities:


The primary responsibilities of the Associate Director/ Director of Process Development will focus on ensuring that the manufacturing process are developed, characterized and optimized in a phase-appropriate manner. This position will require familiarity with authoring CMC regulatory submissions and will serve as a subject matter expert in the process Development function.

  • Author and review key documentation (Standard Operating Procedures, Process Flow Diagrams, Sample Maps, Test Methods, etc.) in support of internal and external projects
  • Author, review and approve tech reports, qualification/validation protocols, test methods and batch records
  • Develop a culture of continuous improvement by identifying opportunities, making formal recommendations and driving initiatives to completion
  • Foster a culture of strong cGMP compliance
  • Effectively split time between people leadership activities and being available for technical leadership at the bench.
  • Mentor process development team members to achieve CMC team objectives
  • Identify new technologies and collaborate with research and development and manufacturing personnel to advance the overall understanding of the processes and how they impact the final product
  • Develop, understand, and manage tools and templates to quantify impact and criticality for parameters and attributes within manufacturing unit operations
  • Demonstrate outstanding technical acumen, operational understanding and cGMP compliance
  • Assist in root cause analysis and establishment of effective CAPA for any deviations impacting the manufacture or release of final product
  • Evening and/or weekend work, along with domestic travel, may occasionally be required based on project need


Qualifications:


  • Ph. D./M.S. in life sciences, ideally Chemistry, chemical Engineering, Immunology etc preferred. B.S. will be considered with additional 5 years of industrial experience
  • At least 5 years of direct supervisory experience of technical professionals and in providing guidance, mentorship and support to direct reports so that they can best manage their teams and projects
  • Proven effective people leadership skill via direct and matrix relationships.
  • Experience in authoring relevant CMC sections of regulatory submissions
  • Self-starter with demonstrated ability to deliver high-quality results in a fast-paced development environment
  • Working knowledge of statistical software (R, JMP, Minitab, etc.)
  • Background in Biologics or Cellular Therapy Manufacturing is required
  • Ability to prioritize multiple tasks, work under various timeline pressures, and drive tasks to completion
  • Must demonstrate solid time management and organizational skills, with good verbal and written communication.


Competencies Needed:


  • Change management
  • Leadership
  • Team Building
  • Future planning
  • Strategic planning
  • Attention to detail
  • Art of listening
  • Resourcefulness
  • Planning and organization
  • Self confidence
  • Intuition
  • Effective time management
  • Regulatory compliance
  • cGMP
  • Statistical Process Control
  • Problem solving
  • Strong communication skills
  • Analytical and research skills
  • Sound judgement and decision making


ImmPACT Bio USA, Inc., is a clinical-stage company dedicated to the discovery of transformative chimeric antigen receptor (CAR) T-cell therapies for cancer patients who have exhausted their treatment options. The company’s logic-gate-based CAR T platforms address key biological challenges in treating cancer. ImmPACT Bio’s technologies are specifically designed to prevent antigen escape, prevent ‘on-target – off-tumor’ toxicities, and overcome the immunosuppressive tumor microenvironment.


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