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Job Title : Associate Scientist II Injectable Drug Product
Development
Location : New Haven, CT
MBR : Onsite 5 Days a Week
Contract Length : 1 Year
The position will join the Injectable Drug Product Development (IDPD) group of
AstraZeneca Rare Disease Product Development and Clinical Supply (PDCS) department. The job entails experimental work on various aspects of drug product characterization, including analytical testing and biophysical comparability testing. The position will also support the maintenance and regular system suitability testing of the group s UPLC systems, and function as an SME for UPLC assay support. The ability to work with minimal supervision as well as part of the team is essential.This is what you will do :
The position will join the Injectable Drug Product Development (IDPD) group of Alexion-AstraZeneca Rare Disease Product Development and Clinical Supply (PDCS) department. The job entails experimental work on various aspects of drug product characterization, including analytical testing and biophysical comparability testing. The position will also support the maintenance and regular system suitability testing of the group s UPLC systems, and function as an SME for UPLC assay support. The ability to work with minimal supervision as well as part of the team is essential.
You will be responsible for :
Maintenance and weekly system suitability testing of Waters UPLC systems, including coordination of service calls with instrument vendors, as necessary.Authoring and maintaining internal procedural documents related to UPLC systems.Acting as a subject matter expert for UPLC assays, including but not limited to size exclusion chromatography, ion-exchange chromatography, and reverse phase assays for quantitation of formulation excipients.With some supervision, design and execute comparability studies for Alexion s clinical drug candidates and commercial products, characterizing protein drug 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.).Assist in preparation of internal technical reports on the executed studies with minimal supervision.Participate in cross-functional development teams.You will need to have :
BS or MS degree in Chemistry, Biochemistry, Pharmaceutical Science, Chemical Engineering, or relevant field with 2 to 4 years relevant work experience with a pharmaceutical or biotechnology company.Solid understanding of protein stability, thermodynamics, and mechanisms of protein degradation.Experience working with HPLC / UPLC systems in an analytical capacity.Experience with DLS, CD, DSC, AUC and / or Nanotemper.The ability to execute experiments with minimal supervision is required. Can prioritize multiple assigned tasks and projects. The ability to work independently as well as part of the team is essential.The individual must be able to work in a collaborative setting and have the ability to adhere to timelines.Excellent interpersonal skills are required, as is the strong ability to communicate effectively.Experience with various software packages like MS Office programs, including Word, Excel, Outlook, and PowerPoint.The ability to take the 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 / 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 for you to have :
Experience working with biophysical and / or analytical testing of protein therapeutics.High level proficiency with Waters UPLC systems and Waters Empower 3.Familiarity with regulatory guidelines (ICH, GxPs, etc.).High level proficiency in MS Office software including Word, Excel, Outlook, and PowerPoint. Experience with visual basic for applications (VBA) is a plus.Experience with SAS JMP or similar statistical analysis software (Prism, Origin, etc.).Programming / scripting experience in any capacity (coursework, professional, hobby, etc.) is a plus.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.
