Associate Scientist II, Injectable Drug Product Development

AstraZeneca • New Haven, CT

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About The Position

The Associate Scientist II is part of the Injectable Drug Product Development (IDPD) team within the Pharmaceutical Development and Clinical Supply (PDCS) department at Alexion-AstraZeneca Rare Disease. The role involves experimental work on drug product formulation and process development to support manufacturing, characterization, and analytical and biophysical comparability testing. The candidate will work with some supervision and both independently and collaboratively, designing and executing studies and preparing development reports and other required documentation. Duties are generally conducted in a laboratory environment.

Requirements

• BS or MS degree in Biochemistry, Pharmaceutical Science, Chemical Engineering, or a relevant field, with 2 to 4 years of relevant work experience at a pharmaceutical or biotechnology company.
• Scientific and practical knowledge of protein/peptide biochemistry, protein formulation, and stability.
• Experience with imaged capillary electrophoresis (iCE/Maurice), H/UPLC (IEX, SEC), DLS, CD, DSC, AUC, and NanoTemper.
• Ability to execute experiments with minimal supervision, work collaboratively, and adhere to timelines.
• Excellent interpersonal, collaboration, and communication skills.
• Ability to take initiative in problem solving and finding solutions to scientific challenges.
• Experience with MS Office programs, including Word, Excel, Outlook, and PowerPoint.
• Ability, with or without accommodation, to lift/carry 15 pounds unassisted or 30 pounds assisted; work comfortably in a controlled environment around biological, infectious, and hazardous materials; gown and degown PPE; use a computer; communicate by phone, video, and electronic messaging; engage in problem solving, analysis, and dialogue; collaborate with others; and maintain general availability during standard business hours.

Nice To Haves

• Hands-on experience with process development, scale-up, tech transfer, and manufacturing.
• Experience with sub-visible particle testing and characterization.
• Experience with biophysical and analytical testing.
• Familiarity with regulatory guidelines.
• High proficiency in MS Office software, including Word, Excel, Outlook, and PowerPoint.
• Experience with electronic record-keeping software such as ELN, EndNote, and e-logbooks.
• Experience maintaining laboratory instrumentation, including organizing preventive maintenance, data backup, and software upgrades.

Responsibilities

• Design and execute formulation and process development studies for clinical biologic candidates, with some supervision.
• Execute drug development studies, including physicochemical characterization and stability studies for clinical and commercial drug products.
• Characterize conformational and colloidal stability using industry-standard methods, such as circular dichroism, differential scanning fluorimetry, analytical ultracentrifugation, and size-exclusion chromatography with multi-angle light-scattering detection.
• Maintain organized records and use team tools to keep multiple assignments on track.
• Assist in preparing internal technical reports on executed studies with minimal supervision.
• Participate in cross-functional development teams.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level