Executive Director, Process Engineering
Company: AstraZeneca
Location: Montgomery Village
Posted on: June 26, 2025
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Job Description:
If you have the passion and the drive to accelerate growth and
make people’s lives better – then AstraZeneca is the place for you.
In Operations we have a big ambition – to deliver more medicines to
patients, quicker and more affordably. Backed by the investment,
leadership and a clear plan to get there, we bring personal
dedication and out of the box thinking. AstraZeneca turns molecules
to medicines, bringing our Research & Development pipeline to life
through a rigorous process of development, manufacturing, testing
and delivery. Operations is accelerating, fast. We are on track for
Our Bold Ambition 2030, delivering 15 new medicines driving us
forward across different modalities including biologics, cell
therapy, ADCs and small molecules. Position Summary 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. 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. Preferred 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. Skills and Competencies 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. When we put unexpected teams in the same room,
we fuel bold thinking with the power to inspire life-changing
medicines. In-person working gives us the platform we need to
connect, work at pace and challenge perceptions. That’s why we
work, on average, a minimum of three days per week from the
Gaithersburg, MD or Santa Monica, CA office. We balance the
expectation of being in the office while respecting individual
flexibility. Join us in our unique and ambitious world. The annual
base salary for this position ranges from $269,000 to $328,900.
However, base pay offered may vary depending on multiple
individualized factors, including market location, job-related
experience. If hired, employee will be in an “at-will position” and
we reserve the right to modify base salary (and any other
discretionary payment or compensation program) at any time,
including for reasons related to individual performance, Company or
individual department/team performance, and market factors.
Keywords: AstraZeneca, Bel Air South , Executive Director, Process Engineering, Manufacturing , Montgomery Village, Maryland
