Director, Late-Stage Process Development, Process Engineering

We are looking for an experienced leader to lead our cell therapy Late-Stage Process Development team. The Director Late-Stage Process Development Process Engineering will oversee pivotal process development process characterization and post-approval process improvement of cell therapy manufacturing processes.

This is a leadership position responsible for developing and managing a team of scientists/engineers. You will help ensure that our cell therapy manufacturing processes are designed and characterized for the efficient commercialization. You will collaborate with teams including R&D MS&T and Manufacturing Operations for the successful development and commercialization of cell therapy products.

We are looking for an experienced people manager with expertise in cell therapy manufacturing process development and process characterization. This position will report to Executive Director Process Engineering Cell Therapy Development and Operations and is located in Santa Monica CA.

Role Accountabilities

• Lead the late-stage process development for cell therapies within the Process Engineering function managing multiple development projects

• Lead pivotal process development process characterization and post-approval process improvement of cell therapy manufacturing processes

• Provide technical leadership for developing new and improved manufacturing processes to enable high-quality and cost-effective cell therapy products

• Develop technical standards and templates for the late-stage process development workflow to enable a state-of-the art knowledge management system including authoring of commercial manufacturing process description raw material consumable and equipment description in-process and release testing sample plan and manufacturing process control strategy documents

• Direct and guide engineers/scientists to deliver high-quality technical documentation for the study design laboratory execution and report authoring activities

• Drive innovation by integrating internal and external scientific advancements incorporating the latest technologies and automation advancements in the cell therapy manufacturing

• Author and review CTD sections for INDa clearance and market approval applications

• Maintain a collaborative science-focused innovative agile and continuous improvement culture within the Process Engineering team

Education Qualifications Skills and Experience

• Ph.D. in Chemical Engineering Biochemical Engineering Bioengineering Biochemistry Biotechnology or a related field or a Masters degree with relevant industry experience

• 8 years of experience in manufacturing process development preferred with 4 years in a leadership role within the biotechnology or biopharmaceutical industry with a focus on cell therapy or biologics

• Experience in cell therapy or biologics late-stage process development and commercialization is a must

• Demonstrated ability to design and execute process characterization (Stage 1 validation) workflow to deliver integrated control strategy

• Proven record of managing and leading a team of laboratory scientists/engineers with preferred expertise in CAR-T and/or human stem cell therapies

• Ability to lead and contribute to CTD authoring for INDa clearance and/or market approval.