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AstraZeneca · 1 month ago

Senior Process Engineer, Downstream Process Characterization & Commercialization

US - Gaithersburg - MD

Full-time

Onsite

Senior Level

$103K/yr - $155K/yr

5+ years exp

AstraZeneca is a leading pharmaceutical company focused on innovation and life-changing medicines. They are seeking a motivated Senior Process Engineer to support downstream process characterization and commercialization activities, focusing on various downstream unit operations and regulatory support.

BiopharmaBiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine

Comp. & Benefits

H1B Sponsor Likely

Responsibilities

Design, implement and support process characterization studies (DOE, multivariate studies, scaling assessments) for all downstream unit operations

Perform data analysis, author technical reports, and present study outcomes to cross-functional teams

Support development and refinement of control strategies, CPP/ CQA linkages, and process validation approaches

Conduct batch record review, deviation evaluation, and data trending to ensure process robustness

Apply AI-enabled tools and digital analytics to accelerate data review, trend analysis, batch record evaluation, and process understanding, driving faster and more consistent decision-making during late-stage development

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

Participate in technology transfer to internal manufacturing facilities and CDMOs; support fit-for-purpose assessments and alignment on process parameters and acceptance criteria

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

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

Contribute to authoring and reviewing CMC content, including: Process descriptions, Characterization summaries, PPQ protocols and reports, Comparability justifications, Control strategy elements

Assist with preparation of BLA/MAA submission documents and responses to regulatory questions

Work closely with upstream, fill-finish, analytical sciences, quality, regulatory, and manufacturing partners to ensure technical alignment

Represent downstream characterization activities in technical meetings and governance discussions

Support lifecycle management, post-approval changes, and process optimization initiatives

Qualification

Downstream bioprocess operationsProcess characterizationAI tools proficiencyGMP experienceDOE designExecutionTechnical writingRisk assessment knowledgeBLA/MAA filing supportData analysisCross-functional collaboration

Required

Ph.D. in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field (2+ years industry experience); OR M.S. with 5+ years of experience; OR B.S. with 7+ years of hands-on industry experience

Experience with downstream bioprocess unit operations, preferably in viral vector

Experience with late-stage development, PPQ principles, and process characterization approaches

Demonstrated proficiency in employing AI tools and digital solutions (e.g., data extraction, document drafting, analysis, workflow automation) to enhance efficiency and accuracy, with the ability to quickly adopt and integrate new AI technologies into daily work

Practical experience with GMP environments, batch record execution or review, deviations, and investigations

Strong technical writing skills and experience with structured data analysis

Preferred

Experience supporting late-stage viral vector programs (lentiviral, AAV, adenoviral, VLPs, etc.)

Experience with DOE design and execution, and multivariate data analysis tools

Experience supporting BLA/MAA filings or contributing to CMC sections

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

Formal training or certification in AI, digital analytics, or automation tools, demonstrating the ability to apply current digital solutions to process development, data analysis, and documentation workflow

Benefits

Short-term incentive bonus opportunity

Equity-based long-term incentive program

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)