Associate Scientist II (Injectable Drug Product Development)

This is what you will do: 

The Associate Scientist II candidate will be a part of the Injectable Drug Product Development (IDPD) team within the Pharmaceutical Development and Clinical Supply (PDCS) department at Alexion-AstraZeneca Rare Disease. The job entails experimental work on various aspects of drug product formulation and process development activities in support of drug product manufacturing, characterization, including analytical and biophysical comparability testing. The ability to work with minimal supervision as well as being part of a collaborative team is essential. The position entails study design, execution, and preparation of development reports and other required documentation. 

You will be responsible for: 

• With some supervision, design and execute formulation and process development studies for clinical biologic candidates.  

• Execute drug development studies including physico-chemical characterization and stability studies for clinical and commercial drug products.  

• Characterize conformational and colloidal stability using industry standard methodology (e.g., circular dichroism, differential scanning fluorimetry, analytical ultracentrifugation, size-exclusion chromatography with multi-angle light scattering detection, etc.) 

• Maintain organized records and use team tools to keep multiple assignments on track. 

• Assist in the preparation of internal technical reports on executed studies with minimal supervision.  

• Participate in cross-functional development teams. 

You will need to have: 

• BS or MS degree in Biochemistry, Pharmaceutical Science, Chemical Engineering, or relevant field. 

• Minium of 1+ years of relevant work experience with a pharmaceutical or biotechnology company  

• Scientific and practical knowledge of protein/peptide biochemistry, protein formulation, lipid-based nanoparticle (LNP) development, and stability are essential. 

• Experience of working with imaged capillary electrophoresis (iCE/Maurice), H/UPLC’s (IEX, SEC), DLS, CD, DSC, AUC, and NanoTemper 

• Experience with gene editing product development (mRNA based and LNP process development) is highly desirable. 

• Ability to execute experiments with minimal supervision is required.  

• The individual must be able to work in a collaborative setting and has ability to adhere to timelines is essential.  

• Excellent interpersonal, collaborative and communication skills 

• Ability to take initiative in problem solving and finding solutions to scientific challenges. 

• Experience with various software packages like MS Office programs, including Word, Excel, Outlook, and PowerPoint 

• 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/degown PPE; use a computer; engage in communications via phone, video and electronic messaging; engage in problem solving and non-linear thought, analysis and dialogue; collaborate with others; maintain general availability during standard business hours.   

We would prefer you to have: 

• Hands-on experience with process development, scale up, tech transfer, and manufacturing. 

• Experience working with sub-visible particle testing and characterization. 

• Experience of working with biophysical and analytical testing 

• Familiarity with regulatory guidelines. 

• High level proficiency in MS Office software including Word, Excel, Outlook, and PowerPoint. 

• Experience with electronic record keeping software, like ELN, EndNote, e-logbooks; maintenance of laboratory instrumentation (organizing PMs, data backup, SW upgrade, etc.) will be a plus.