Jobs / United States / Astrazeneca Pharmaceuticals Lp
Senior Director, Manufacturing Science and Technology, Cell Therapy Technical Operations
Astrazeneca Pharmaceuticals Lp · 🇺🇸 US - Gaithersburg - MD
Sponsorship verdict
Sponsorship possible
One solid signal, not two — worth applying, and worth asking about sponsorship early.
- Employer is on a government sponsor recordThe US Department of Labor certified 99 H-1B/E-3 labor condition applications for this employer between Oct 2025 and Jun 2026 (latest Jun 2026) — the step every H-1B hire needs first. USCIS also records 31 H-1B approvals in FY2023. Source: LCA disclosure data (US Department of Labor (OFLC)).
- The posting doesn’t mention sponsorshipSilence isn’t a refusal — ask the recruiter before investing much time.
- No salary bar for this routeH-1B has no fixed salary bar: the employer must pay at least the prevailing wage for the role and area. Cap-subject employers enter a lottery weighted by wage level. Source: https://www.federalregister.gov/documents/2025/12/29/2025-23853/weighted-selection-process-for-registrants-and-petitioners-seeking-to-file-cap-subject-h-1b, rules effective 2026-02-27.
- What Astrazeneca Pharmaceuticals Lp paid sponsored hires in similar roles2 certified filings for “Statistical Science Associate Director” (Statisticians) in DE: $205k–$209k, median $207k. Most were filed at wage level I (50%) — 1 lottery entry, ≈15% projected selection odds for cap-subject employers. Source: US Department of Labor LCA disclosure data (Oct 2025 – Jun 2026).
- Confirmed live todayWhen a source last listed this job as open.
US H-1B: cap-subject employers enter a lottery weighted by wage level — Level I gets 1 entry, Level IV gets 4 (DHS projected selection odds ≈15% at Level I to ≈61% at Level IV). Universities and non-profit research employers are cap-exempt. The $100,000 fee for new petitions from abroad is currently blocked by a court order (appeal pending).
A verdict summarises public evidence; it is not legal advice and never a guarantee — the employer and the immigration authority decide. Sign in to factor in where you can already work.
Or apply yourself on the official page →
Sponsor Radar — Astrazeneca Pharmaceuticals Lp
The US Department of Labor certified 99 H-1B/E-3 labor condition applications for this employer between Oct 2025 and Jun 2026 (latest Jun 2026) — the step every H-1B hire needs first. USCIS also records 31 H-1B approvals in FY2023. Source: LCA disclosure data (US Department of Labor (OFLC)).
Past sponsorship or register membership never guarantees sponsorship for this vacancy or for you. Full Sponsor Radar for Astrazeneca Pharmaceuticals Lp →
About the role
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 with Late-stage Process Development, site Manufacturing Science and Technology , and Manufacturing Operations teams. 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 s