Associate Scientist II (Injectable Drug Product Development)

This is what you will do:

TheAssociate Scientist IIcandidate will be a part of the Injectable Drug Product Development (IDPD) teamwithinthePharmaceutical Development and Clinical Supply (PDCS) departmentatAlexion-AstraZeneca Rare Disease. The job entails experimental work on various aspects of drug productformulationandprocess developmentactivities insupportofdrug product manufacturing,characterization, includinganalyticalandbiophysicalcomparabilitytesting. The ability to work with minimal supervision as well asbeing partofa collaborativeteam is essential. The position entailsstudy design, execution, andpreparation of development reports and other required documentation.

You willbe responsible for:

• With some supervision, design and executeformulation and processdevelopment studies for clinicalbiologiccandidates.

• Executedrug development studies includingphysico-chemicalcharacterizationand stability studies forclinical and commercial drugproducts.

• Characterizeconformational and colloidal stabilityusing industry standardmethodology(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.

• Assistin the preparation ofinternal technical reports on executed studies with minimalsupervision.

• Participate incross-functional developmentteams.

You will need to have:

• BS or MS degreein Biochemistry, Pharmaceutical Science, Chemical Engineering, or relevantfield.

• Minium of1+yearsofrelevant work experience with a pharmaceutical or biotechnology company 

• Scientific and practical knowledge of protein/peptidebiochemistry, protein formulation,lipid-basednanoparticle(LNP)development,andstabilityareessential.

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

• Experience with gene editing product development(mRNAbased and LNPprocessdevelopment)is highlydesirable.

• Abilityto execute experiments with minimal supervision isrequired. 

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

• Excellentinterpersonal, collaborative and communication skills

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

• Experience with varioussoftwarepackageslikeMS Office programs, including Word, Excel, Outlook, and PowerPoint

• The duties of this role aregenerally conductedin 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/degownPPE; 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 wouldpreferyou to have:

• Hands-on experience with processdevelopment, scaleup,tech transfer, andmanufacturing.

• Experience working with sub-visible particle testing andcharacterization.

• Experience of working with biophysical and analytical testing

• Familiarity with regulatory guidelines.

• High levelproficiencyin MS Office softwareincludingWord, 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.