JOB SUMMARY

The Downstream Process Development (PD) Scientist II provides process development ownership for a product, including all development and design decisions, with some oversight and supervision from senior process development staff. They can apply advanced scientific principles to design and execute laboratory studies for unit operation development and optimization, and solve problems of increasing scope and complexity. They possess a strong working knowledge of the downstream functional area with strong aptitude in chromatography and tangential flow filtration, and a developing understanding of phase-appropriate practices and expectations. 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 II 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.

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 some oversight. 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 lead the downstream portion of development, process characterization, and/or technology transfer programs, acting as subject matter expert (SME), and directing the efforts of the team in meeting the project deliverables.
• Provide technical support for cGMP manufacturing through floor coverage, batch document review, and support of deviations and change controls with some oversight.
• Responsible for developing/maintaining a current understanding of cGMP and other regulatory requirements.
• Adheres to all safety requirements and assures that departmental employees comply with required safety procedures.
• Conceptualizes, proposes and executes 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.
• Documents procedures, observations, and results in laboratory notebooks and responsible for maintaining training compliance, according to site expectation. Reviews documentation and records as assigned.

REQUIREMENTS

B.S. degree and a minimum of 6+ years of related experience; M.S. and 4+ years of related experience or Ph.D. and 1+ 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.

Salary: $106,480-$146,410