Executive Director, Process Engineering

AstraZeneca•Gaithersburg, MD

2d•$269,000 - $328,900•Hybrid

About The Position

We are looking for an experienced Executive Director of Process Engineering to lead our cell therapy process engineering team. The Executive Director will oversee the design, scale-up, and optimization of cell therapy manufacturing processes. This is a new leadership position responsible for building out a team. You will help ensure that our cell therapy products are manufactured, cost-effectively, from early development through commercialization. The Executive Director will collaborate with teams, including R&D, Quality, Manufacturing, and Regulatory Affairs, to the successful development of process engineering solutions. We are looking for an understanding of cell therapy manufacturing, advanced process technologies, and regulatory requirements, and experience in leadership. You will report to the Vice president of Analytical and Process Development. The position can be based in Gaithersburg, MD or Santa Monica, CA.

Requirements

Ph.D. in Chemical Engineering, Bioengineering, Biotechnology, or a related field, or a Master’s degree with relevant industry experience.
10+ years of experience in process engineering preferred, with at least 10 years in a leadership role within the biotechnology or pharmaceutical industry with a focus on cell therapy or biologics.
Experience in cell therapy or biologics manufacturing, including process design, scale-up, and optimization.
Knowledge in GxP compliance and data integrity.
Proven track record in managing and leading a large, high-performing team (30+ members) with preferred expertise in CAR-T and human stem cell therapies, biologics, process development, transfer, validation, and automation.
Demonstrated ability in developing value-added manufacturing processes from scratch.
Diversified experience in a wide spectrum of CMC development suitable for adequately producing cell therapeutics.

Responsibilities

Lead the Late-Stage Process Development function for Cell Therapies within the CTO, managing multiple development projects across several locations.
Create and deploy global technical standards for cell therapy, focusing on process validation, sterility assurance, raw materials, single-use technology, and packaging, all within established quality systems.
Design and oversee process validation, qualification, and monitoring strategies, implementing master validation plans for processes, equipment, and facilities in collaboration with Subject Matter Experts.
Build and manage a multi-site organization that supports the product portfolio, ensuring efficient processes, knowledge exchange, and integration of lessons learned.
Oversee resource allocation and make strategic "make vs. buy" decisions based on project priorities and technology strategies, adhering to CTO CGT governance processes.
Drive innovation by integrating internal and external expertise, incorporating the latest technologies, and leading digital programs aligned with CTO CGT strategies.
Ensure compliance with all relevant regulations (e.g., ISEC, GMP, HSE), and manage regulatory submissions, including the creation of source documents and dossier modules.
Provide technical leadership for developing new and improved processes for high-quality cell therapy production.
Author and review regulatory CMC packages for IND filings and approval applications (BLA/MAA/NDA).
Address process development inquiries from health authorities during global product filings and approvals.
Oversee and ensure the delivery of process development, qualification, and transfer from Process Development to Operations for GMP manufacturing of clinical and commercial cell therapy products.
Fulfil all post-approval commitments for commercial products to health authorities.