Senior Scientist II, Downstream Development (Scale-Up Laboratory Lead)
AbbVie
5 months ago
On-site
South San Francisco, CA
$109,500 - $208,500 USD yearly
Operations
Responsibilities:
- Lead downstream scale-up lab activities and non-GMP material generation for purification process CMC development and transfer.
- Maintain scale-up lab operational readiness (equipment, workflows, consumables, scheduling).
- Serve as downstream scale-up/tech transfer SME; guide purification transfer to scale-up lab and GMP manufacturing.
- Lead technology transfer to internal sites and external partners (transfer package prep, batch support, issue resolution).
- Serve as AKTA SME; develop and execute methods using UNICORN software.
- Execute downstream unit operations (chromatography, filtration, viral clearance, UF/DF, formulation); provide hands-on leadership in column packing, buffer prep, setup, and operation.
- Develop/implement scale-up lab workflows, procedures, and documentation; design scale-down/up studies to build understanding and robustness.
- Troubleshoot process/equipment issues; partner with vendors.
- Identify next-gen purification platform strategies; partner across matrix teams.
- Mentor junior scientists; author/review technical, transfer, and regulatory support documents.
- Maintain safety, documentation, and data integrity.
Qualifications:
- BS (12+ yrs) / MS (10+ yrs) / PhD (4+ yrs) in Chemical Engineering, Biochemistry, Chemistry, or related.
- Significant downstream/purification CMC experience for biologics; expertise in scale-up/scale-down and tech transfer.
- Deep hands-on AKTA + UNICORN experience.
- Hands-on TFF (hundreds of grams), affinity/polishing column packing (3–20 L), single-use systems, depth/virus/chromatography membrane filtration, and large-volume formulation.
- Experience with analytical methods (HPLC, CE, UV quantitation, impurity characterization).
- Strong communication, independent experimental design, leadership, troubleshooting, and documentation.
Preferred:
- Led a downstream scale-up lab/technical development function; supported transfers to pilot/GMP/CDMOs.
- Experience with mAbs/bispecifics/complex modalities; platform purification advances; statistical/data analysis for scale-up.
Benefits (if eligible): paid time off, medical/dental/vision, 401(k); eligibility for long-term incentive programs.
- Lead downstream scale-up lab activities and non-GMP material generation for purification process CMC development and transfer.
- Maintain scale-up lab operational readiness (equipment, workflows, consumables, scheduling).
- Serve as downstream scale-up/tech transfer SME; guide purification transfer to scale-up lab and GMP manufacturing.
- Lead technology transfer to internal sites and external partners (transfer package prep, batch support, issue resolution).
- Serve as AKTA SME; develop and execute methods using UNICORN software.
- Execute downstream unit operations (chromatography, filtration, viral clearance, UF/DF, formulation); provide hands-on leadership in column packing, buffer prep, setup, and operation.
- Develop/implement scale-up lab workflows, procedures, and documentation; design scale-down/up studies to build understanding and robustness.
- Troubleshoot process/equipment issues; partner with vendors.
- Identify next-gen purification platform strategies; partner across matrix teams.
- Mentor junior scientists; author/review technical, transfer, and regulatory support documents.
- Maintain safety, documentation, and data integrity.
Qualifications:
- BS (12+ yrs) / MS (10+ yrs) / PhD (4+ yrs) in Chemical Engineering, Biochemistry, Chemistry, or related.
- Significant downstream/purification CMC experience for biologics; expertise in scale-up/scale-down and tech transfer.
- Deep hands-on AKTA + UNICORN experience.
- Hands-on TFF (hundreds of grams), affinity/polishing column packing (3–20 L), single-use systems, depth/virus/chromatography membrane filtration, and large-volume formulation.
- Experience with analytical methods (HPLC, CE, UV quantitation, impurity characterization).
- Strong communication, independent experimental design, leadership, troubleshooting, and documentation.
Preferred:
- Led a downstream scale-up lab/technical development function; supported transfers to pilot/GMP/CDMOs.
- Experience with mAbs/bispecifics/complex modalities; platform purification advances; statistical/data analysis for scale-up.
Benefits (if eligible): paid time off, medical/dental/vision, 401(k); eligibility for long-term incentive programs.