Role Summary
The Technical Pilot Plant Downstream Purification (TPP-DSP) group purifies proteins in intermediate to large scale batches to support early to late-stage development projects. Collateral duties include generating data to enable robust technology transfers to clinical and commercial manufacturing facilities and evaluating new purification technologies. The TPP-DSP group is part of the Bioprocess Engineering department and of the larger Sanofi Global CMC Development organization.
Responsibilities
- Execute electronic batch records.
- Prepare single-use assemblies, buffers and solutions used in the manufacturing process.
- Perform routine equipment calibration and qualifications.
- Operate downstream purification equipment such as chromatography and tangential flow filtration skids.
- Routinely move heavy barrels and equipment.
- Maintain adequate levels of supplies.
- Assist in creating standard operating procedures and batch records and their continuous improvement.
- Schedule and coordinate PM and calibration activities to ensure equipment readiness.
- Participate in implementing new technologies such as integrated and continuous processing, and inline buffer conditioning.
Qualifications
- Required: Bachelor's degree in chemical engineering, biochemistry or related discipline.
- Required: Associate degree in scientific discipline with minimum two years of relevant experience, mainly in protein purification activities such as chromatography, tangential flow filtration and viral filtration.
- Required: Must be able to work in a team setting.
- Preferred: Laboratory experience, in either an academic or industrial setting.
- Preferred: Experience purifying proteins at gram level.
- Preferred: Ability to program Unicorn controlled skids.
- Preferred: Excellent communication skills.
- Preferred: Ability to work within a team; understanding of scientific principles underlying purification technologies and operations.
- Preferred: Excellent organization, written and oral presentation skills.
- Preferred: High level of scientific curiosity.
Education
- Bachelor's degree in chemical engineering, biochemistry or related discipline (Required).
- Associate degree in scientific discipline with relevant purification experience (Required).
Additional Requirements
- Routinely move heavy barrels and equipment.