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AstraZeneca · 10 hours ago

Process Engineer, Upstream Process Characterization & Commercialization

Gaithersburg, MD

Full-time

Onsite

Mid, Senior Level

$76K/yr - $114K/yr

1+ years exp

AstraZeneca is seeking a highly motivated Engineer to support upstream process characterization and commercialization activities for viral vector programs. The role involves contributing to late-stage development, process characterization, and technology transfer while providing technical leadership during engineering and commercial campaigns.

BiopharmaBiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine

Comp. & Benefits

H1B Sponsor Likely

Responsibilities

Design, execute, and support upstream process characterization studies (DOE, multivariate studies, scale‑down models, and scale‑up assessments)

Develop and execute characterization strategies to define CPP–CQA linkages for upstream unit operations

Perform data analysis, technical report authorship, and presentation of study outcomes to cross‑functional teams and governance forums

Support development and refinement of control strategies for upstream processes, including raw materials, transfection reagents, cell banks, and process parameters

Conduct batch record review, deviation assessment, and data trending to ensure robustness of upstream manufacturing processes

Apply AI‑enabled tools and digital analytics to accelerate data review, trend analysis, batch record evaluation, and process understanding

Contribute to PPQ planning, readiness, execution, and documentation for upstream processes

Support technology transfer of upstream processes to internal manufacturing sites and CDMOs, including fit‑for‑purpose assessments and scale translation

Provide on‑the‑floor technical support during scale‑up, engineering runs, PPQ batches, and commercial manufacturing campaigns (including off‑shift support when required)

Support raw material risk assessments, comparability studies, and process risk evaluations across facilities and platforms

Contribute to authoring and review of CMC documentation, including upstream 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 upstream manufacturing

Work closely with downstream, analytical sciences, quality, regulatory, and manufacturing teams to ensure end‑to‑end process alignment

Represent upstream characterization activities in technical meetings, reviews, and governance discussions

Support lifecycle management, post‑approval changes, and continuous improvement initiatives for upstream processes

Qualification

Upstream viral vector manufacturingTransient transfection processesBioreactor systemsProcess characterizationAI tools proficiencyGMP environments experienceTechnical writingData analysisCross-functional communicationExperimental designProblem-solving skills

Required

Ph.D. in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field with 1+ years of industry experience; OR M.S. with 4+ years; OR B.S. with 5+ years of hands‑on industry experience

Hands‑on experience with upstream viral vector manufacturing, including transient transfection‑based processes

Experience with shake flask, bench‑scale, pilot‑scale, and commercial bioreactor systems; experience with Amber systems strongly preferred

Experience with late‑stage development, process characterization, and PPQ principles for upstream processes

Demonstrated proficiency in applying AI tools and digital solutions to data analysis, documentation, and workflow automation

Experience working in GMP environments, including batch record execution or review, deviations, and investigations

Strong technical writing, data analysis, and problem‑solving skills

Preferred

Experience supporting late‑stage viral vector programs (lentiviral, AAV, adenoviral, VLPs)

Experience designing and executing DOE and multivariate data analysis for upstream processes

Experience contributing to BLA/MAA submissions or regulatory interactions

Knowledge of control strategy development and risk assessment tools (e.g., FMEA)

Formal training or demonstrated application of digitalization, automation, or AI‑enabled tools in bioprocess development

Benefits

Short-term incentive bonus opportunity

Equity-based long-term incentive program (salaried roles)

Retirement contribution (hourly roles)

Commission payment eligibility (sales roles)

Qualified retirement program [401(k) plan]

Paid vacation and holidays

Paid leaves

Health benefits including medical, prescription drug, dental, and vision coverage

Company

AstraZeneca

Glassdoor4.1

AstraZeneca is a pharmaceutical company that discovers, develops, manufactures, and markets prescription medicines. It is a sub-organization of Investor.

Founded in 1999

Cambridge, Cambridgeshire, GBR

10001+ employees

https://www.astrazeneca.com

H1B Sponsorship

AstraZeneca has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2021 (2)

2020 (11)