Scientist Senior Associate

Job Details Independently design and execute experiments to characterize and enable implementation of new technologies that advance state-of-the art automation, high throughput screening, filling, and analytical capabilities. Independently design and execute studies to characterize drug product formulations and processes to deliver robust productso Conduct studies to measure drug product stability under various stresses, e.g. formulation screening under accelerated or forced degradation conditions, UF/DF, filtration, and freeze/thaw, for products in various formulations and formats (liquid, lyophilized, vials, pre-filled syringes, etc.) Evaluate product attributes through analytical testing, e.g. measurement of pH, conductivity, osmolality, protein concentration, SEC, CEX, subvisible and visible particle characterization. Apply fundamental scientific and engineering principles (chemistry, kinetics, statistics, etc.) to solve challenges and evaluate effects of process stresses, process improvements, equipment, scale, and raw materials Conduct analysis of data generated from the above listed activities, including statistical analysis using SAS, JMP, etc., and effectively communicate results Serve as primary point of contact and subject matter expert (SME) on complex capabilities and own business process:o Write and own SOPs/methods/user guidance documentso Manage interface with project teams for successful execution of studieso Maintain equipment procedures, study log books, scheduling, metrics, training, etc. Participate in data management initiatives, such as integration of data from lab instruments with Electronic Lab Notebooks (ELN) to streamline and automate data collection Design, optimize and maintain Sharepoint site content Troubleshoot malfunctioning equipment, work with Lab Operations, Asset Management and vendors to repair Author/review technical documents, such as technical protocols, technical assessments, regulatory documents Assist with and coordinate new equipment procurement and installation Perform tasks related to safety and compliance initiatives in the lab, including resolution of observations Manage inventory levels of commonly used lab supplies and chemicalsPreferred Qualifications: Hands-on experience in designing and executing automation and high throughput screening studies on liquid handling platforms (e.g. Tecan, Hamilton, Andrew, Unchained Labs, etc.) Hands-on experience in executing typical protein characterization techniques, i.e. SEC-UHPLC or CEX-UHPLC, concentration measurement via UV-Vis, viscosity, density. Experience with programming (e.g. Python, R, MATLAB) and database languages (e.g. SQL), as well as data visualization tools (e.g. Tableau, Spotfire) Familiarity and relevant knowledge of pharmaceutical/biotechnology process development, esp. formulation development and Drug Product unit operations, e.g. UF/DF, filling, lyophilization Experience with Sharepoint and website design Critical thinking, problem solving and independent research skills Good organizational skills with strong attention to detail Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions/SOPs, and comply with company policies Ability to elevate relevant issues to project lead and line-management Excellent communication (oral and written) Strong project management skills including the ability to manage project resource requirements (material, Client, time, etc.) Self motivation, adaptability and a positive attitude Ability to work independently and as part of a team with internal and external partners Ability to participate in cross-functional teams and work effectively in a fast-paced, dynamic and highly matrixed team environment