Downstream Process Development Associate Scientist

Responsibilities

• Executes process development, process characterization, and technology transfer of microbial processes to commercial cGMP facility.
• Works toward developing a broad knowledge of state-of-the-art principles and theory.
• Produces high quality documentation and client reports suitable for publication and regulatory requirements.
• Compiles and presents data to clients.
• Supports downstream process development efforts in the laboratory and manufacturing areas.
• Executes experiments with oversight and support.
• Conceptualizes and proposes process development and manufacturing based on process data.
• Executes experiments including downstream unit operations such as chromatography, tangential flow filtration, normal filtration, as well as sampling and basic analysis of process samples; concentration, pH, and conductivity.
• Assists in the downstream portion of development, process characterization, and/or technology transfer programs.
• Provides technical support for cGMP manufacturing through floor coverage, batch document review, and support of deviations and change controls with mentor/managerial oversight.
• Develops/maintains a current understanding of cGMP and other regulatory requirements.
• Documents procedures, observations, and results in laboratory notebooks and responsible for maintaining training compliance, according to site expectation.
• Reviews documentation and records as assigned.
• May contribute to the evaluation, development and implementation of new downstream technologies leading to process improvements and efficiency of operation in support of downstream process development and manufacturing activities.
• Adheres to all safety requirements and assures that departmental employees comply with required safety procedures.
• Reacts to change productively and handles other essential tasks as assigned.

Requirements

• B.S. degree and a minimum of 5+ years of related experience; M.S. and 3+ years of related experience or Ph.D. and 0+ years related experience in a scientific discipline.
• Experience with downstream process development and chromatography equipment required.
• Excellent written and verbal communication skills, focus on customer service, and ability to meet strict client deadlines.
• Highly collaborative.
• Flexibility of hours to support downstream processes.
• Knowledge of GMPs and biotechnology-derived product regulations preferred.