Jobs / United States / Astrazeneca Pharmaceuticals Lp
Associate Director, Process Development, Cell Therapy
Astrazeneca Pharmaceuticals Lp · 🇺🇸 US – Santa Monica Colorado Avenue – CA
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 roles15 certified filings for “Associate Director Oncology Outcomes Research” (Medical Scientists, Except Epidemiologists) in MD: $126k–$185k, median $140k. Most were filed at wage level II (47%) — 2 lottery entries, ≈31% 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).
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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
Position Summary The Associate Director, Late-Stage Cell Therapy Process Development, will provide scientific and technical leadership for the development, characterization, and transfer of manufacturing processes for cell therapy products. This role is responsible for leading a team of scientists and engineers supporting process development activities from clinical development through commercialization, including BLA and global regulatory submissions. The successful candidate will partner cross-functionally with Manufacturing, Quality, Regulatory Affairs, Analytical Development, and CMC teams to ensure robust, compliant, and scalable manufacturing processes. Key Responsibilities Technical Leadership • Lead the late-stage process development for cell therapies within the Process Engineering function, managing multiple development projects • Direct and guide engineers/scientists to deliver high-quality technical documentation for the study design, laboratory execution and report authoring activities • Perform risk assessment, data analysis, write technical reports, and present outcome of the studies to cross‑functional teams and governance forums • Conduct batch record review, deviation assessment, and data trending to ensure robustness of cell therapy manufacturing processes • Apply AI‑enabled tools and digital analytics to accelerate data review, trend analysis, batch record evaluation, and process understanding Team Leadership and Management • Build, develop, and manage a high-performing team of process development scientists and engineers • Establish project priorities, resource allocation, and departmental objectives • Foster a collaborative and innovation-driven culture PPQ & Tech nology Transfer • Support PPQ activities including but not limited to protocol authoring, batch record authoring and planning • Support technology transfer of cell therapy processes to internal manufacturing sites including make-a-batch assessments and drafting manufacturing batch records Lifecycle Management • Lead lifecycle management activities for commercial cell therapy products, including process monitoring, continuous improvement, post-approval changes, comparability assessments, and regulatory commitments. • Partner with Manufacturing, Quality, Regulatory Affairs, and Technical Operations to implement process improvements, maintain process control, and support ongoing commercial readiness. Manufacturing Support & Scientific Deviation Management • Serve as the Process Development and Engineering SME for manufacturing operations, providing scientific support for deviations, investigations, atypical events, and process-related issues. • Lead root cause analyses, impact assessments, and CAPA development using data-driven and risk-based approaches to ensure product quality, compliance, and uninterrupted manufacturing operations. Regulatory Support • Contributes to authoring and reviewing CMC documentation, including cell therapy process descriptions, characterization summaries, PPQ protocols and reports, and control strategy elements. • Support preparation of BLA/MAA submissions and responses to regulatory questions related to cell therapy manufacturing. Cross ‑ Functional Collaboration • Work closely with analytical sciences, quality, regulatory, and manufacturing teams to ensure end‑to‑end process alignment. • Represent cell therapy characterization activities in technical meetings, reviews, and governance discussions. Required Qualifications • Ph.D. in Chemical Engineering, Biochemical Engineering, Biological Sciences, Biotechnology, Pharmaceutical Sciences, or related discipline with 6 + years of industr