Scientist III, Injectable Drug Product Development jobs in United States
cer-icon
Apply on Employer Site
company-logo

Alexion Pharmaceuticals, Inc. · 5 days ago

Scientist III, Injectable Drug Product Development

Alexion Pharmaceuticals, Inc. is focused on developing life-changing medicines. The Scientist III will lead formulation and process development for injectable biologics, collaborating with cross-functional teams and mentoring junior members.

BiotechnologyHealth CareMedicalTherapeutics
check
Comp. & Benefits
check
H1B Sponsor Likelynote

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 methodsScale-up studiesData softwareLaboratory instrumentationGlobal Regulatory knowledgeAUC expertiseInterpersonal skillsMentoringProblem solving

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

Alexion Pharmaceuticals, Inc.

company-logo
Alexion, AstraZeneca Rare Disease is focused on pioneering new possibilities for the rare disease community.

H1B Sponsorship

Alexion Pharmaceuticals, Inc. 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
2025 (49)
2024 (57)
2023 (51)
2022 (29)
2021 (27)
2020 (17)

Funding

Current Stage
Public Company
Total Funding
$5.8M
2020-12-12Acquired
1999-02-12Post Ipo Equity· $5.8M
1996-02-29IPO

Leadership Team

leader-logo
Frederic Chereau
SVP, Strategy and Business Development
linkedin
leader-logo
Imran Shakur
Director, IRT and Technology Lead
linkedin
Company data provided by crunchbase