Scientist III, Injectable Drug Product Development

AstraZeneca
United States
Workplace: OnsiteFull timeFunction: Research & Scientific (R&D)Experience: 5+ yearsEducation: phdSkills: ["Communication","Collaboration","Mentoring","Problem solving","Scientific leadership"]

Lead end-to-end injectable drug product development for parenteral biologics, from candidate selection through commercial validation and regulatory filing. Apply process engineering and scale-up fundamentals to design, model, optimize, and transfer manufacturing unit operations. Use computational modeling and simulation (e.g., CFD and process models) to de-risk scale-dependent behavior, and provide scientific leadership for phase-appropriate formulation development across multiple biologic modalities. Collaborate across CMC, QA, analytics, and manufacturing and author key technical/regulatory documentation.

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FursaFursa
AstraZeneca
AstraZeneca
3 days ago

Scientist III, Injectable Drug Product Development

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Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI
Last checked: 4 hours agoStatus: Live
Reposted: similar role first listed 6 months ago

Job Summary

Lead end-to-end injectable drug product development for parenteral biologics, from candidate selection through commercial validation and regulatory filing. Apply process engineering and scale-up fundamentals to design, model, optimize, and transfer manufacturing unit operations. Use computational modeling and simulation (e.g., CFD and process models) to de-risk scale-dependent behavior, and provide scientific leadership for phase-appropriate formulation development across multiple biologic modalities. Collaborate across CMC, QA, analytics, and manufacturing and author key technical/regulatory documentation.
Location: United States
Workplace: Onsite
Employment Type: Full time
Job Function: Research & Scientific (R&D)
Seniority: Mid level

Key Responsibilities

  • •Drive end-to-end injectable drug product development across candidate selection, clinical supply, commercial validation, and regulatory filing.
  • •Design, optimize, and scale drug product unit operations (e.g., compounding/mixing, sterile filtration, fill/finish, freeze–thaw, hold steps, viscosity management) to define process design space and critical process parameters.
  • •Apply computational modeling and simulation approaches (e.g., CFD and heat/mass transfer models, mechanistic/empirical process models, DoE-based predictive models) to predict scale-dependent effects and de-risk manufacturing.
  • •Lead or support technology transfer to internal and external (CDMO) manufacturing sites, including authoring process descriptions, batch record inputs, and supporting validation and troubleshooting.
  • •Design and execute biophysical/analytical studies to support formulation and process decisions, integrate datasets into control strategies/specifications, and author protocols/technical reports and CMC regulatory sections (IND/IMPD, BLA/MAA).

Key Requirements

  • •PhD in Chemical Engineering, Pharmaceutical Sciences, Chemistry, Biochemistry, Biophysics, or a relevant field with 5+ years of industry experience; or MS with 14+ years; or BS with 15+ years.
  • •Demonstrated experience leading or significantly contributing to injectable/parenteral biologic drug product development across the full lifecycle, including formulation, process development, and technology transfer.
  • •Strong process engineering fundamentals and expertise in process modeling/simulation (e.g., CFD, mechanistic and empirical scale-up correlations) for drug product unit operations such as fill/finish, mixing, and filtration.
  • •Scientific and practical foundation in protein biochemistry, biophysics, protein formulation, and stability for parenteral biologics.
  • •Ability to design, execute, and troubleshoot laboratory studies using advanced biophysical and analytical instrumentation, and communicate effectively across functions.
Experience:5+ yearsPharmaceuticalsBiotechDrug developmentInjectable biologics
Education:PhD / Doctorate in Chemical Engineering, Pharmaceutical Sciences, Chemistry, Biochemistry, Biophysics, or a relevant field
Skills:CommunicationCollaborationMentoringProblem solvingScientific leadership
Tech Stack:CFDDoEJMPMinitabMS OfficeWordPowerPointExcelGraphPadVisioAdobe ProEndNoteElectronic lab notebooksSEC-MALSDLSAUCCE-SDSCIEFNanoDSFDSC

Company Brief

AstraZeneca
Global biopharmaceutical company discovering, developing and commercializing prescription medicines across oncology, cardiovascular, renal & metabolism, respiratory, and immunology, focused on innovative therapies and vaccines to improve patient outcomes worldwide.
Industry: Pharmaceuticals
Company Size: Enterprise (1,001+ employees)
Revenue: USD 1B+
Growth: Public Company
Valuation: Public Company (Market Cap in USD)
Funding: IPO / Publicly Listed
Headquarters: Cambridge, United Kingdom
Founded: 1999
Glassdoor
Glassdoor: 3.8
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