Manufacturing Scientist II

Major Responsibilities:

This position will perform a variety of tasks associated with manufacturing of protein and enzyme products. This position will be involved in all phases of product release, ensuring use of only approved materials, validation protocols, and release criteria. In addition to manufacturing responsibilities, this position will also assist in the development and growth of the Protein Chemistry area and assist in overseeing its daily operations. This position will assist in accurately documenting ideas, concepts and procedures, including assisting in writing new procedures as required by company’s Quality Management System which is compliant with 21 CFR Part 820 and ISO 13485 guidelines.

Activities:

• Characterization of recombinant and native proteins using immunoassays and enzyme activity assays.
• Verification of protein and antibody purity and quality through SDS-PAGE (Coomassie/silver), westerns, and immunoassays.
• Western blotting for analysis of recombinant proteins and/or purified antibodies.
• Protein concentration determination (NanoDrop, Bradford, and BCA assays)
• Independently plan and perform routine Manufacturing of finished reagents, including in-process materials in sufficient quantities as required, ensuring inventory in all levels are secured and properly maintained.
• Assist in the development, improvement, re-formulation, optimization, and scale-up of assigned protein and enzyme products that meet required specifications and customer requirements following company’s Design Control procedure.
• Work cooperatively with other Production Scientists and Manufacturing staff ensuring that all required raw materials, processes and quality tests are accurately documented, and specifications can consistently be met.
• Assist in the development and documentation of methods and procedures to manufacture and test new high quality diagnostic products at a competitive cost.
• Assist in planning and performing stability studies, when required, to determine projected and actual product shelf-life in accordance to regulatory guidelines.
• Identify and correct problems that may adversely affect product performance, analysis, or reporting of assay results, and identify opportunities for product and process improvement.
• Participate in activities associated with Quality System and regulatory compliances, inspections, and filings, ensuring compliance with Enzo’s Quality System and Federal and State laws.

About You:

Education: MS or PhD (3+ years) in scientific field

Experience: Extensive technical and scientific skills pertaining to protein and enzyme purification, antibody production and purification, experimental design and data analysis and interpretation with strong analytical and problem solving skills

Skills: Excellent documentation and record keeping skills; Excellent general laboratory and organizational skills including the ability to work independently with minimal supervision and to train others in laboratory methods; Ability to manage multiple priorities and meet deadlines; Flexibility in responding to changing demands; Proven ability to work effectively in a team environment

Salary range estimated for this position based in New York is $75,000-85,000.