The role of the Research Scientist is to conduct experiments for the purposes of commercial support for downstream biopharmaceutical manufacturing.
The candidate will support ultrafiltration/diafiltration, filtration, bulk fill, freezing, storage and cold chain shipping operations for biologics drug substance.
Responsibilities include the operation, cleaning and maintenance of laboratory equipment, the preparation of buffers and reagents, documentation of experimental data and results, data verification and the preparation of study protocols and final reports.
Appropriate GLP/GMP procedures must be followed. This position also involves troubleshooting and problem solving of process related problems observed at manufacturing scale through the effective design of scale-down studies and the evaluation of data from manufacturing lots.
The successful candidate will work effectively in cross-functional project teams and also work independently to accomplish project goals.
The position offers the opportunity to interface with Process Development, Pilot Plant, Manufacturing, Manufacturing Support, Quality Assurance, Analytical, Supply Chain and Global Regulatory Sciences groups. Strong communication and technical writing skills are required.Qualifications:
B.S. or M.S. degree in Pharmaceutical Sciences, Biological or Chemical Sciences/Engineering or related disciplines
Knowledge of common protein analytical tools and demonstrated experimental skills for lab work are required.
Knowledge of protein freezing/thawing, formulation and stability is desired.
Ultrafiltration/diafiltration, filtration, process development, characterization, and/or validation experience are desired.
Candidates must possess good organizational skills and strong attention to details, excellent experimental/troubleshooting aptitude, and be self motivated.
Experience with cGMP regulations, regulatory requirements, and CMC authoring for biologics processes are a plus.