Job Description
- The position is required to join Injectable Drug Product Development group.
- 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 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 client's pharmaceuticals’ 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.)
- Prioritize multiple assigned tasks and projects. The ability to work independently as part of the team is essential.
- Execute drug developability studies including physicochemical characterization, UPLC analysis, and stability studies for the client's rare disease pharmaceuticals’ drug candidates and commercial products.
- Assist in preparation of internal technical reports on the executed studies with minimal supervision.
- Participating in cross-functional development teams
- BS or MS degree in Biochemistry, Pharmaceutical Science, Chemical Engineering, or relevant field with 0-2 (MS) or 2-4 (BS) years relevant work experience with a pharmaceutical, CRO, CDMO 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.
- The ability to execute experiments with minimal supervision is required.
- The individual must be able to work in a collaborative setting and having the 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 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.
- Experience of working with biophysical testing and analytical testing
- Familiarity with low volume analytical assays.
- 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 is preferred.
- The individual must be able to work in a collaborative setting and ability to adhere to timelines is essential.
- Excellent interpersonal skills are required, as is the strong ability to communicate effectively.
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