Associate Scientist II, Injectable Drug Product Development

Alexion • New Haven, CT

7d

About The Position

The Associate Scientist II will join the Injectable Drug Product Development team within the Pharmaceutical Development and Clinical Supply department at Alexion-AstraZeneca Rare Disease. The role involves experimental work in drug product formulation and process development to support manufacturing, characterization, and analytical and biophysical comparability testing. The successful candidate will work with some supervision and contribute both independently and collaboratively. Responsibilities include designing and executing studies and preparing development reports and other documentation. The role is generally conducted in a laboratory environment, with general availability required during standard business hours.

Requirements

• Bachelor’s or master’s 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 or 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.
• Ability to work collaboratively and adhere to timelines.
• Excellent interpersonal, collaborative, and communication skills.
• Ability to take initiative in problem-solving and finding solutions to scientific challenges.
• Experience with Microsoft Office programs, including Word, Excel, Outlook, and PowerPoint.
• Ability, with or without accommodation, to lift or 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 via phone, video, and electronic messaging; engage in problem-solving and non-linear thought, 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, technology transfer, and manufacturing.
• Experience with sub-visible particle testing and characterization.
• Experience with biophysical and analytical testing.
• Familiarity with regulatory guidelines.
• High-level proficiency in Microsoft Office software, including Word, Excel, Outlook, and PowerPoint.
• Experience with electronic record-keeping software such as ELN, EndNote, or 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