Scientist I - Process Development

The Scientist performs method development, product and process development, scale up/scale down processing and purification, performing a wide variety of activities including but not limited to the following:

• Leads operation and maintenance of lab-scale and process scale chromatography systems (GE Akta systems, Unicorn 7).
• Leads operation and maintenance of lab-scale and production scale filtration systems including manual and automated normal flow and tangential flow filtration, depth filtration, centrifugation, and other clarification systems.
• Leads preparation and formulation of buffers defined in standard operating procedures
• Leads and assists in drafting and reviewing standard operating procedures, work instructions, test methods, material specifications, and process development production records.
• Initiation of investigations, deviations, and implementation of resulting corrective actions into existing procedures. Assist in out-of-specification review via CAPA and/or change control forms.
• Maintenance of activity records, log books, and general inventories in designated laboratory areas following GDP standards.
• Perform general cleaning and sanitization of equipment and general production areas according to procedures. 
• Expression and purification of recombinant proteins using a variety of expression systems.
• General analytical chemistry, protein biochemistry and molecular biology methods such as liquid chromatography (HPLC, FPLC and low-pressure systems), gel electrophoresis, western blotting, ELISA, PCR, protein assays, enzyme/bioactivity assays and bioinformatics.
• General laboratory methods, such as filtration, centrifugation, bio-separations, spectroscopy, light microscopy and image analysis.
• Assist in research, product and process development for both current and new products (including hands-on work).
• Maintain proper documentation of all laboratory activities following GDP standards. Write R&D protocols and reports in support of R&D product development.
• Perform product testing in support of R&D product development.
• Contribute to validation protocols and reports.
• Assist in training of manufacturing personnel at time of design transfer
• Maintain R&D inventory supply and ordering.
• Contribute to optimization and improvements of GMP products.
• Write SOPs, work instructions, test methods, material specifications, and other product development documents.
• Assist in out-of-specification review via CAPA and/or change control forms.
• Provide support to Manufacturing, Quality Assurance and other departments as needed.
• All other tasks as needed or assigned by supervisor.

Minimum Educational Requirements for Competency:

• BA or BS degree in molecular biology, biochemistry, chemistry or related field with 5+ years experience in laboratory sciences/biotech/biopharma, MS in cell, molecular biology, biochemistry or related field with 2+ years experience in laboratory. sciences/biotech/biopharma. Experience working in regulated environment, familiar with GLP/GMP and Quality Systems is a plus.
• Strong leadership, technical, communication and organization skills in a teamwork environment
• Strong verbal / written and interpersonal communication skills as a team player and willing to work in an environment where individual initiative, collaboration and accountability are valued.
• Ability to work independently with minimal supervision