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AstraZeneca · 22 hours ago

Scientist III, Injectable Drug Product Development

US - New Haven - CT

Full-time

Hybrid

Senior Level

5+ years exp

AstraZeneca is a company committed to eliminating cancer as a cause of death by innovating life-changing medicines. The Scientist III role focuses on leading formulation and process development for injectable biologics, involving complex data interpretation, cross-functional collaboration, and mentoring junior team members.

BiopharmaBiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine

Comp. & Benefits

H1B Sponsor Likely

Responsibilities

Leading phase appropriate formulation and process development for injectable biologics, translating program goals into experimental plans, decision criteria, timelines, and risk mitigation from candidate selection through commercial validation and filings

Designing, executing, and troubleshooting laboratory studies using advanced biophysical and analytical methods, with hands on responsibility for high quality data generation

Defining and optimizing drug product processes (fill/finish relevant unit operations, viscosity management, filtration, mixing, hold steps), conducting scaleup and robustness studies, and supporting technology transfer to internal and external manufacturing sites

Integrating complex datasets to establish structure–function relationships, degradation pathways, and mechanism informed stress models; translating insights into robust formulations, control strategies, and phase appropriate specifications

Authoring protocols, technical reports, and contributing to CMC sections of regulatory submissions, including comparability assessments and responses to regulatory queries

Cross functional collaboration with to align development plans and ensure timely program delivery

Mentoring junior team members in matrix teams; reviewing study designs and data; promoting experimental rigor and documentation excellence

Work with senior management, partners, and cross functional teams; presenting program status, risks, and recommendations; taking initiative to solve scientific and operational challenges

Qualification

Protein biochemistryProcess developmentRegulatory submissionsAnalytical methodsLaboratory instrumentationData softwareInterpersonal skillsMentoringProblem solvingCollaboration

Required

PhD in Chemistry, Biochemistry, Biophysics, Chemical engineering, or relevant field with 5 years of proven experience

MS with 14 years or BS with 15+ years of proven experience

Excellent interpersonal skills

Ability to mentor and empower others within the team and cross-functionally

Scientific and practical knowledge of protein biochemistry, protein formulation, and stability

Make strategic scientific/technical proposals based upon corporate or project objectives and can take initiative in problem solving and finding solutions to scientific challenges

The duties of this role are generally conducted in a lab environment. As is typical of a lab-based role, employees must be able, with or without an accommodation to: lift/carry 15/30 pounds unassisted/assisted; work comfortably in a controlled environment with and around biological, infectious, and hazardous materials; gown/de-gown PPE; use a computer; engage in communications via phone, video, and electronic messaging

Preferred

Electronic record keeping and data software, (electronic lab notebooks, EndNote)

Maintenance of laboratory instrumentation (prioritizing preventative maintenance, data backup, software upgrade, etc.), as well as MS Word, PowerPoint, Excel/GraphPad, Visio, JMP/Minitab, and Adobe Pro

Knowledgeable in Global Regulatory guidance, cGMPs, and Quality/Compliance expectations for the development of parenterals

Validated background in protein chemistry, chemistry, biochemistry, or equivalent

Hands-on experience with process development, scale up, and tech transfer to manufacturing sites

Expertise in AUC

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)