Downstream Process Development Associate Scientist

KBI Biopharma • Boulder, CO

1d

About The Position

The Downstream Process Development (PD) Associate Scientist provides process development input and co-ownership for a product, including all development and design decisions, with oversight and mentorship from senior process development staff. They learn to apply scientific principles to design and execute laboratory studies for unit operation development and optimization. They possess a developing working knowledge of the downstream functional area with developing aptitude in one or more operations, including chromatography and tangential flow filtration. They author and review technical documents including protocols and reports commensurate with PD compliance and quality standards. This workflow encompasses process development scope as well as support of technology transfer activities in preparation for cGMP production. The PD Scientist I is responsible for maintaining training compliance, according to site expectations. This is a salaried exempt position, with the expectation to cover shift work as needed to support laboratory activities and organizational need.

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.

Nice To Haves

• Knowledge of GMPs and biotechnology-derived product regulations preferred.

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.
• Responsible for producing 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.
• Execution includes 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.
• Will assist in the downstream portion of development, process characterization, and/or technology transfer programs.
• Provide technical support for cGMP manufacturing through floor coverage, batch document review, and support of deviations and change controls with mentor/managerial oversight.
• Responsible for developing/maintaining 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

Benefits

• challenging, rewarding and fast-paced environment
• opportunity for career advancement through the development of one’s technical skills
• collaborative, team environment, where sharing knowledge and expertise with one another is strongly encouraged

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level