Associate Scientist II

Job Description

Job Summary:

• The contractor position is responsible for the development, optimization, and qualification of Bioassay, Binding, and Impurities to support product characterization, release, and stability for Client Biologics.
• This position will also perform routine non-GxP sample testing to support process development and formulation development.

Duties and Responsibilities:

• Supports Development, optimization, and qualification of bioassays to evaluate biological, biochemical, and cellular activities for therapeutic proteins
• Supports qualification for process-derived impurity methods to support process development
• Performs routine non-GxP samples testing to support process development and formulation development
• Reviews ELNs and verifies data in method development, qualification/pre-validation reports
• Data trending analysis
• Supports drafting SOPs, study plans, protocols, method development/qualification reports
• Positively contributes to improving the working environment, and engaged in on-going Client cultural improvement efforts

Requirements:

• Bachelor’s degree with knowledge and some hands-on experience of analytical method development with high preference in ELISA binding assay/enzymatic assay/cell-based assay.
• Scientific skills in biochemistry/molecular/cellular biology with good understanding of biological pathways and biotherapeutics’ mechanism of actions
• Ability to take initiative in data trending analysis.
• Excellent interpersonal skills and a strong ability to communicate effectively
• High level of proficiency in MS Office software including Word, Excel, Outlook, Visio, PowerPoint, JMP and SoftMax Pro (SoftMax Pro is optional).
• The duties of this role are generally conducted in a lab environment.

Physical Demands:

• 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/de-gown 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.