Assoc Scientist Pharmaceutical Sci|

Location: New Haven, CT 4-5 Days Onsite

This is what you will do:

The position is required to join Injectable Drug Product Development group of XXX 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.

You will be responsible for:

• 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
  
  

You will need to have:

• 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, NanoTemper 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
• 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.
  
  

We would prefer for you to have:

• 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.