Job Description

The position is required to join Injectable Drug Product Development group of  Development and Clinical Supply (PDCS) department. The job entails experimental work on various aspects of drug product characterization, including analytical testing, biophysical comparability testing, and process development to support drug product manufacturing. The ability to work with minimal supervision as well as part of the team is essential. The position entails execution of the studies, data processing and compiling to generate development reports as well as other required documentation.

• With some supervision, design and execute development studies for the company'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.)
• Can prioritize multiple assigned tasks and projects. The ability to work independently as well as part of the team is essential.
• Execute drug development studies including physico-chemical characterization, UPLC analysis, and stability studies for the company's drug candidates and commercial products
• Assist in preparation of internal technical reports on the executed studies with minimal supervision
• Participate  in cross-functional development teams

• BS or MS degree in 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 mechanism of protein degradation.
• Experience of working with imaged capillary electrophoresis (iCE/Maurice), H/UPLC’s (IEX, SEC), DLS, CD, DSC, AUC, and NanoTemper is 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
• Experience with various software packages like MS Office programs, including Word, Excel, Outlook, and PowerPoint
• The duties of this role are 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.?

• Experience of working with sub-visible particulates characterization and testing
• Experience of working with biophysical testing 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.
• Ability to take initiative in problem solving and finding solutions to scientific challenges.
• The individual must be able to work in a collaborative setting and ability to adhere to timelines is essential.
• Excellent people skills are required, as is the strong ability to communicate effectively.

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