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AstraZeneca · 9 hours ago

Senior Engineer, Process Engineering and Packaging

US - Gaithersburg - MD

Full-time

Onsite

Mid, Senior Level

$108K/yr - $162K/yr

5+ years exp

AstraZeneca is a leading pharmaceutical company focused on improving patient outcomes. The Senior Engineer, Process Engineering and Packaging will be responsible for designing and developing manufacturing processes for biologic and novel therapeutic products, as well as supporting tech transfers and validations to ensure quality and operational efficiency.

BiopharmaBiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine

Comp. & Benefits

H1B Sponsor Likely

Responsibilities

Design fill/finish manufacturing processes suitable for clinical or commercial-scale production for biologic and novel therapeutic products

Evaluate current and new manufacturing technology to drive better quality and operational advantages

Develop pilot laboratory capabilities required for biologic and novel therapies

Characterize processes to establish acceptable processing conditions

Support clinical-stage and commercial technical transfers to internal facilities and contract manufacturers

Work within an internal sending unit team including development functions (device, analytical, packaging, formulation, fill and assembly process SMEs), supply chain, project management and QA

Qualification

Biopharmaceutical developmentProcess validationFill-finish operationsExperimental designData analysisRegulatory guidanceLeadershipCommunicationTechnical writing

Required

BS or MS degree in mechanical, chemical, or pharmaceutical engineering, chemistry, materials science, or a related engineering or pharmaceutical science field with 5+ years of experience or a PhD and 0+ years of experience

Introductory-level knowledge in several of the following areas: Biopharmaceutical / combination drug product development, Process validation, Fill-finish unit operations such as filtration, mixing, and aseptic filling, Experimental design, wet-laboratory work, and data analysis, Leadership, communication, technical writing

Preferred

Prior experience in biologic drug development or manufacturing

Knowledge of regulatory guidance (i.e.- biologics, cell and gene therapy, aseptic processing, validation, cGMP, and combination products)

Benefits

Qualified retirement programs

Paid time off (i.e., vacation, holiday, and leaves)

Health, dental, and vision coverage in accordance with the terms of the applicable plans

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)