Senior Process Engineer, Cell Therapy MS&T
Overview
You will own technical oversight of cell therapy manufacturing processes across AstraZeneca's global network, from pivotal clinical tech transfer to commercial launch. 5+ years in cell therapy or biologics MS&T, plus hands-on GMP and CPV expertise, position you to drive process validation and regulatory success. You will partner with process development, quality, and supply chain to standardize operations and mitigate risks. This role stands out for its direct impact on commercialization and lifecycle management in a cutting-edge field.
What You'll Do8
- 1Represent Global MS&T on technology transfer and process characterization teams to ensure successful commercialization.
- 2Bridge Manufacturing Operations with the CMC team, delivering comparability and validation studies on time.
- 3Develop the PPQ readiness and execution framework for site MSAT teams, overseeing on-site implementation.
- 4Implement CPV strategies across sites to maintain process understanding and control.
- 5Identify and execute process improvements that boost robustness, cut cost of goods, and increase throughput.
- 6Lead global change controls and author CMC sections for INDa, BLA, and MAA submissions.
- 7Defend scientific justifications for the integrated control strategy and lifecycle changes to regulators.
- 8Proactively detect and mitigate technical and operational risks, driving standardization across teams.
Requirements7
- 1B.S., M.S., or Ph.D. in chemical, biochemical, or biomedical engineering, or a related discipline.
- 2Ph.D. with 1+ years; M.S. with 5+ years; or B.S. with 7+ years in cell therapy, biologics, or vaccines.
- 3Hands-on expertise in cell therapy manufacturing processes and technologies.
- 4Background in GMP manufacturing operations and technology transfer.
- 5Experience with process validation and CPV.
- 6Proven track record authoring CMC sections for major filings (INDa, BLA, MAA).
- 7Willingness to travel up to 10% domestically and internationally.
Salary Insight
Salary not disclosed in listing
Location
Required Skills
Similar open positions
Explore active roles that match your skills and interests.
4314 AstraZeneca Pharmaceuticals LP Company
VerifiedSenior Director Cell Therapy Manufacturing F&E Lead
You will own facility and engineering strategy for cell therapy manufacturing across AstraZeneca's network. You define user requirements, design standards, and contamination control approaches for cutting-edge cell therapy facilities. Collaborate with Global Real Estate and Engineering to evaluate expansion opportunities. Lead engineering studies for capital investments and new technology adoption. Harmonize F&E operating models and drive Digital and AI solutions across the supply network. This role shapes the future of personalized medicine manufacturing at a global scale.
Just - Evotec Biologics, Inc.
VerifiedPrincipal Process Engineer – Global MSAT
Just Evotec Biologics seeks a Principal Process Engineer to lead global MSAT initiatives focused on improving worldwide access to biotherapeutics. This role involves driving impactful projects and collaborating with talented individuals to achieve success.
4314 AstraZeneca Pharmaceuticals LP Company
VerifiedCell Therapy Strategy & Commercial Executive Director Role
Lead end-to-end strategy for a defined indication within AstraZeneca's Cell Therapy Enterprise. Drive global commercial and strategic initiatives across therapeutic areas while partnering with Clinical and Commercial teams. Shape sustainable brands and manage PH3ID forecasts. Create future-proofed strategies and differentiate early assets. This is a high-impact leadership position reporting to the VP.
Kyverna
VerifiedSr Manager QA Operations, Cell Therapy & GMP
You will own QA operations for CDMOs across plasmid, viral vector, and cell therapy manufacturing, ensuring batch release and compliance for clinical and commercial products. You partner with the Sr Director to lead quality oversight, batch disposition, and continuous improvement, while supporting QP certification and apheresis center onboarding. This role drives inspection readiness and quality metrics in a fast-paced cell therapy environment. You will work with CDMOs, GMP, and ICH guidelines, shaping quality systems for transformative autoimmune treatments.
1010 Celgene - Summit (Corp)
VerifiedSenior Manager Global Clinical Scientist Cell Therapy
Lead scientific strategy for clinical trials at Bristol Myers Squibb. Design and execute trial activities while collaborating with cross-functional teams. Drive meaningful patient impact and career growth. Join a dynamic environment focused on innovation and balance.
4314 AstraZeneca Pharmaceuticals LP Company
VerifiedStudy Physician Neuroimmunology AstraZeneca
Lead study-level clinical decisions for transformative cell therapies in neuroimmunology. Drive patient outcomes while shaping rapid translation of innovative treatments. Report to Global Clinical Head Neuroimmunology and collaborate across enterprise functions.