Assoc Scientist Pharmaceutical Sci ALX US

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform to connect, work at pace and challenge perceptions. Thats why we work, on average, a minimum of three days per week from the office. But that doesnt mean were not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
Associate Scientist II, Analytical Development and Clinical Quality Control
Location: New Haven, CT
Reports To: ADQC
Worker Type: Lab In Vitro
This is what you will do:
The contractor position is responsible for the development, optimization, and qualification of Bioassay, Binding, and Impurities to support product characterization, release, and stability for Biologics. This position will also perform routine non-GxP sample testing to support process development and formulation development.
You will be responsible for:
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 *** cultural improvement efforts
You will need to have:
Bachelors 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. 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