Associate Scientist

Job Description

Job Summary:

• The position is required to join Injectable Drug Product Development group of Client Rare Disease Pharmaceuticals’ Pharmaceutical Development and Clinical Supply (PDCS) department.
• The job entails experimental work on various aspects of drug product characterization, including formulation development, in use compatibility studies for intravenous and subcutaneous administration, process development to support drug product manufacturing support, and particulates testing.
• 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.

Responsibilities:

• With some supervision, design and execute development studies for company 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, 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, particulates testing, and stability studies for company rare disease pharmaceuticals’ 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.

Education and Experience:

• BS or MS degree in Biochemistry, Pharmaceutical Science, Chemical Engineering, or relevant field with 0 to 2 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 H/UPLC’s, imaged capillary electrophoresis (ICE/Maurice), Ion Exchange Chromatography (IEX), Micro-flow imaging (MFI), light obscuration (LO), DLS, Nano-Temper and DSC 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.

Preferred Skills and Experience:

• 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.