We are looking for an experienced leader to lead our cell therapy Manufacturing Science and Technology (MS&T) team. The Director, Manufacturing Science and Technology, Process Engineering, will oversee and ensure rapid commercialization of robust, compliant and cost-effective cell therapy manufacturing processes working with Late-Stage Process Development, site Manufacturing Science and Technology (MS&T) and Manufacturing Operations teams.   

The Director will be responsible for the technical oversight of cell therapy manufacturing processes from at-scale process validation through commercialization and life cycle management of cell therapy products manufactured at internal and external sites. This is a leadership position responsible for developing and managing a team of engineers. You will help ensure that our cell therapy manufacturing processes are tech transferred for clinical and commercial manufacture, validated and commercialized successfully.  

We are looking for an experienced people manager with expertise in tech transfer, site readiness for clinical and PPQ manufacture, process validation and commercialization activities. This position will report to Executive Director, Process Engineering, Cell Therapy Development and Operations, and is located in Gaithersburg, MD. 

Role Accountabilities 

Lead the commercial manufacturing process tech transfer, process validation and market approval for the cell therapy assets 

Collaborate with Late-Stage Process Development, site MS&T, Manufacturing Ops, Quality and Regulatory teams to support product development, tech transfer, and life-cycle management 

Develop and implement robust and site-agnostic tech transfer, process control and process validation strategies to enable clinical and commercial manufacture of cell therapy products 

Develop and implement proactive process analysis strategy to monitor the process performance and oversee process improvement initiatives 

Develop technical standards and templates for the process validation and market approval workflow including, authoring of validation master plan, validation protocols, validation reports and manufacturing campaign summary reports 

Ensure all MS&T activities adhere to the internal quality standards and comply with global regulatory standards for the cell therapy products 

Provide technical expertise and leadership to drive the implementation of process improvements to enable reduction in COGs, increase throughput, facility capacity and quality compliance 

Champion the adoption of the latest technologies and automation advancements in the cell therapy manufacturing to enhance manufacturing efficiency and product quality 

Author and review process validation and commercial manufacturing process related CTD content for the market approval 

Maintain a collaborative, engineering-focused, innovative and continuous improvement culture within the Process Engineering team 

Education, Qualifications, Skills and Experience 

Ph.D. in Chemical Engineering, Biochemical Engineering, Bioengineering, or a related field, or a Master’s degree with relevant industry experience 

8+ years of experience in biologics/cell/gene therapy manufacturing science, tech transfer or late-stage process development, with 4+ years in a leadership role within the biotechnology or biopharmaceutical industry 

Demonstrated ability to design and execute process validation strategies and relevant technical documentation to deliver successful PPQ and support commercial manufacture 

Demonstrated ability to manage process monitoring and post-approval process improvement activities 

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

Ability to author process validation and commercial manufacturing process related content for the market approval 

The annual base salary for this position ranges from $161,252.80 - $241,879.20. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, 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:

A qualified retirement program [401(k) plan]

Paid vacation, holidays, and paid leaves

Health benefits including medical, prescription drug, dental, and vision coverage in accordance with 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.

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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.