Manufacturing Science and Technology Downstream Process Scientist/Engineer

Join the Spark Team

We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable – until now.

We don’t follow footsteps. We create the path.

Summary

The Manufacturing Science and Technology (MST) Downstream Process Scientist/Engineer is an entry-level position within the MST Lab team, which is responsible for carrying out laboratory experiments to support clinical and commercial manufacturing of gene therapy products and late-stage process development activities.  To support manufacturing, the incumbent will develop an understanding of Spark manufacturing processes in order to assist in the evaluation of raw materials and equipment, investigation of process deviations and development of process improvements.  Late-stage process development activities, such as process characterization, will require the incumbent to build an understanding of new processes in the clinical pipeline delivered from the Process Development organization, with whom the incumbent will interact with regularly.

The incumbent’s major responsibility in the activities described above is hands-on execution of bioprocessing laboratory experiments for downstream unit operations, such as tangential flow filtration, preparative chromatography and dead-end filtration.  The experimental scope spans experimental design, in-lab execution, documentation of results using Good Documentation Practices and data analysis.

Responsibilities

80% Working in the lab to perform experiments while synchronously documenting work in electronic laboratory notebooks.

10% Contributing to new manufacturing suite design and preparing documentation for equipment requirements, purchase, installation and qualification.

10% Contributing to process development reports and tech transfer documents

Qualifications

BS in biochemistry or engineering (either chemical, biochemical, or bio), or related area, with 0-2 years of relevant experience.

Knowledge of downstream bioprocessing unit operations.

Hands-on general laboratory or manufacturing experience in either an academic or industrial setting.

Hands-on experience with filtration and chromatography is a plus.

On a regular basis, the Downstream Process Scientist/Engineer needs to work closely with senior lab members to execute various experiments, including complex and large-scale processes.

Strong data organization skills, interpretation and troubleshooting are critical to be successful.

Execute various tasks in a highly accurate manner and deliver the data on time.

Requirements

Must be able to lift 25 pounds.

Must be flexible with work schedule and available to work extended and off hours as determined by management.  Weekend work will not regular but may be necessary on occasion.

Must be able to wear appropriate clean room attire and all Personal Protective Equipment.

Must be able to stand for long periods.

Must be able and willing to comply with COVID19 work plan requirements, which may be dynamic, e.g. intermittent periods of working remote

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