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 Master’s 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.

The annual base salary for this position ranges from $171,426.40 - $257,139.60. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, and experience. Also, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles).

Our Benefits:

Benefits offered include:

A qualified retirement program [401(k) plan]

Paid vacation, holidays, and paid leaves

Health benefits including medical, prescription drug, dental, and vision coverage following the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment.

#celltherapy #LI-Onsite

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.