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 products
  • 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:
  • Write and own SOPs/methods/user guidance documents
  • Manage interface with project teams for successful execution of studies
  • 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 chemicals

Preferred 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, manpower, 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

Basic Qualifications: