Responsibilities:
- Lead downstream scale-up lab activities and non-GMP material generation to support purification process development, optimization, and transfer.
- Maintain scale-up lab operational readiness (equipment, workflows, consumables, scheduling).
- Serve as downstream scale-up/tech transfer SME; guide purification development representatives to transfer to scale-up lab and GMP.
- Lead technology transfer to internal manufacturing and external partners (transfer packages, batch support, issue resolution).
- Act as AKTA SME; develop and execute methods using UNICORN software.
- Execute downstream unit operations (chromatography, filtration, viral clearance, UF/DF, formulation) and provide hands-on leadership (packing, buffer prep, setup).
- Develop scale-down/scale-up studies; troubleshoot issues; partner with vendors.
- Implement next-gen purification platform improvements; mentor scientists; author/review technical and regulatory support documents.
- Maintain safety, documentation, and data integrity.
Qualifications:
- BS (12+ yrs), MS (10+ yrs), or PhD (4+ yrs) in Chemical Engineering, Biochemistry, Chemistry, or related field.
- Significant downstream/purification process development in biologics CMC.
- Proven expertise in process scale-up/scale-down and technology transfer.
- Deep AKTA systems expertise with UNICORN.
- Hands-on large-scale TFF (hundreds of grams), 3β20 L column packing, single-use technologies, depth/virus/membrane filtration, and large-volume formulations.
- Experience troubleshooting and working with vendors; strong leadership, communication, and experimental design.
Preferred:
- Experience leading a downstream scale-up lab/technical function; GMP/CDMO transfer experience.
- Experience with monoclonal antibodies/bispecifics and next-gen platform purification; statistical/data analysis knowledge.
Benefits (as stated): Paid time off; medical/dental/vision; 401(k); eligible for long-term incentive programs.