Process Engineer Cell Therapy Jobs in Silver Spring, MD

AstraZeneca is seeking a Senior Director of Manufacturing Science and Technology (MSAT) to serve as senior-technical leader for the end-to-end Cell Therapy manufacturing across a global network of AstraZeneca's manufacturing sites. You 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.

Your group will own the cell therapy manufacturing lifecycle from tech transfer of the pivotal manufacturing process to the process validation, commercialization, and post-approval process improvements partnering withLate-stageProcess Development,site Manufacturing Science and Technology,and Manufacturing Operationsteams.

Responsibilities:

Team Leadership & Strategy

• Define and execute the Global MSAT function strategy aligned with Cell Therapy Technical Operations to enable development and supply objectives across clinical and commercial stages.

• Build, mentor, and develop a high-performing Global MSAT team with deep expertise in cell therapy technical development and operations.

• Serve as a core member of the CMC lifecycle management team, contributing to long-range supply planning, risk mitigation, and operational excellence.

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

Development and Manufacturing Interface

• Represent Global MSAT in the technology transfer and process characterization teams to ensure successful commercialization of cell therapy products

• Represent Manufacturing Operations in the CMC team, ensuring high-quality and timely program deliverables (clinical & commercial supply, site approvals)

• Develop PPQ readiness and PPQ execution technical framework for the site MSAT team and oversee execution at the manufacturing sites

• Develop and implement Proactive Process Analysis (PPA) and Continued Process Verification (CPV) strategies across manufacturing sites to ensure continued process understanding and process control across all manufacturing sites

Lifecycle Management

• Provide technical oversight across cell therapy manufacturing lifecycle - from pivotal manufacturing readiness to commercial and post-approval.

• Develop and manage post-approval process optimization initiatives, comparability strategies, ensuring scientific rigor and managing regulatory risks.

• Identify and implement process improvements that improve process robustness, cost of goods, plant throughput, and supply continuity.

• Proactively identify and mitigate technical and operational risks; drive lessons-learned cycles and standardization across sites and teams.

Regulatory & Quality Support

• Serve as the senior accountable MSAT leader for regulatory submissions - Pivotal INDa, BLA, MAA, and supplements - authoring and approving CMC sections with high efficiency and optimal content.

• Lead MSAT preparedness and technical support for health authority inspections and audits.

• Partner with quality and regulatory to maintain full compliance with cGMP, ICH guidelines, and global regulatory expectations.

• Develop and defend sound scientific justifications for the integrated control strategy, and lifecycle changes.

• Lead global Change Controls and ensure timely implementation and compliance working with site MSAT team

Cross-Functional Partnerships:

You will work in close partnership with:

• Quality - ensuring process compliance and product quality standards

• CMC Regulatory - aligning on submission strategy and regulatory positioning

• Supply Chain - informing long-range supply planning and risk mitigation

• CMC Leadership - providing MSAT input for late-stage development and commercial readiness

• Governance - participate in Change Controls and Technical Governance Committees

Qualifications:

Education

• B.S or M.S. or Ph.D. in Chemical/Biochemical/Biomedical Engineering, Bioengineering, Biochemistry, Biotechnology, Cell Biology, or a closely related discipline. Advanced degree preferred.

Experience

• 12+ years of progressive experience for cell therapy/biologics/vaccines modalities in technical development, manufacturing operation, CMC leadership or CMO management areas.

• Technical expertise in cell therapy manufacturing processes and technologies is highly desirable. Experience in the biologics or viral vectors or vaccines will be considered.

• Extensive background in GMP manufacturing operations, process validation, PPQ, CPV, and regulatory submission preparation.

• Proven record of building, leading, and mentoring high-performing technical and cross-functional teams.

• Demonstrated success authoring and defending CMC sections for major regulatory filings (INDa, BLA, MAA) and leading health authority inspections.

Leadership Competencies

• Strategic thinker with the discipline and execution focus to translate vision into operational results.

• Skilled at leading through influence - particularly in remote and matrixed environments.

• Executive-level communication skills; equally effective with scientific peers, manufacturing partners, regulatory agencies, and senior leadership.

• High standards of quality, accountability, and urgency - with the resilience to thrive in a fast-paced cell & gene therapy field.

• Collaborative, team-oriented approach balanced with the decisiveness required of a senior technical authority.

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 office. But that doesn't mean we're not flexible. 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$216,996.00 - 325,494.00. 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.

Date Posted

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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.