Lead all Drug Substance CMC authoring/reviewing/approving of M3 BLA for Viaskin Peanut Patch. Coordinate additional CMC characterization activities as needed.Over 20 years of broad CMC experience in start-up through large biotech companies. Have contributed to/led many early stage (Pre-IND), IND/IMPD and 3 late stage BLA programs through CMC regulatory approval and commercialization. Strong technical writing for biologics with experience in INDs, IMPDs, BLAs, briefing documents, due diligence and regulatory responses.High-throughput screening/PD/Process Characterization/Tech transfer expertViral Clearance expert

Lead and manage all outsourced CMC activities for development and production (non-GMP and GMP) of CLB-3000 (2 antigens + adjuvant), which is a therapeutic vaccine for the treatment of patients chronically infected with hepatitis B virus.This includes:Cell banking (RCBs, MCBs)Fermentation process development and scale-up (Pichia pastoris)Lysis (chemical and mechanical) and purification of antigens (development and scale-up)FormulationAssay development and method qualification/validationStability Studies (MCB and antigens)Oversight of all CDMO activities including:SOP/batch record/change control reviewsStability protocols PiPRegulatory document authoring/review including (IMPD)Manage all CDMO activities for new process development for purification of antigen variants of Hepatitis B surface antigen (HBsAg) for improved yield and purity.

• Manage CDMO activities for all mAb recovery and purification related process development, tech transfer and manufacturing campaigns for 3 pipeline ADC programs: SBT6050, SBT6290 and SBT8230• Review reports and assist with cell culture, conjugation, and formulation activity management• Identify and engage with various CDMOs for producing future ADCs and 2nd sourcing current suppliers• Work with CDMO and vendors to secure raw materials (and back-ups) during the supply chain issues stemming from the pandemic• Review budgets, approve timelines and SOWs for early and late-stage activities• Review and approval of eBRs, deviation investigations/CAPAs• Lead CMC activities for Pre-clinical candidates. Coordinated meetings and data sharing with research, protein engineering, biology, and chemistry for choosing the final mAb/ADC/Linker-payload candidate to go into IND-enabling activities• Lead CMC for Pre-IND briefing books and business development data summary presentations• Author regulatory dossier CMC sections in M3 and M2. Review all sections.• Help to establish a company-wide quality management system by representing CMC during document/SOP/protocol reviews• Oversee CDMO activities for developing a process-specific HCP assay• Assisted with experimental design, development/campaign reports for cell culture activities until hiring of a cell culture SME• Designed and approved IND-enabling viral clearance validation studies• SME in all recovery and purification techniques including filtration (depth, viral, sterile, adsorptive membranes), chromatography (ProA, AEX, CEX, HIC, mixed-mode, affinity)

• Commercial mAb Purification lead/CMC team member for 2 ADCs targeting AML and solid tumors• Interact with multiple collaborators and CMOs for process characterization studies, mAb generation• Author/review CMC sections in INDs, IMPDs and BLAs, regulatory compliance• Contribute to mAb and ADC SOWs and control strategy development for Process validation• FMEA/Risk Assessments to establish NORs/AORs/CATR (Critical Attribute Target Ranges and CQAs (Critical Quality Attributes), CPPs (Critical Process Parameters)• Statistical Analyses including JMP, excel• DOE design, execution and analysis• Industry collaborator on QbD (article co-author)- viral clearance SME• Purification lead/Process Team Lead/CMC Team member for multiple Ph1 mAb/ADC (antibody-drug conjugate) and bispecific programs• High-throughput (HT) initiative champion. Leader of a cross-functional team for linking all depts with HT efforts. Help to develop HT workflows from research through development and analytical sciences and formulations. Qualify new HT purification scale-down model to expedite process dev/understanding/characterization work while also reducing resources (Manuscript pending)• Prior Knowledge task force contributor– Viral clearance lead (SGEN SME)• Manage a team of 5 direct reports including salary/equity rewards• Strong collaborator. Foster professional development of my team.• Strong understanding of CLD timelines, Upstream processes and Analytical MethodsProcess Development and HTS for removal of hitch-hiker proteins including enzymes.Team member (Purification) for strategy development for SGEN Sr staff planning through 2025Purification representative for cross-functional team developing strategies for accelerating late stage activities (development, characterization, validation)

Built and Developed the HTPD platform in Downstream allowing commercial process troubleshooting and support activities to coincide with new process development and characterization with fewer people and less material saving the company $.Process development of antigens for activated cellular immunotherapies for fighting cancer.Core team representative for Protein Product Development and lead downstream scientist for activities pertaining to the antigen used in a new immunotherapy targeted to bladder cancer.Leading the second generation downstream development activities and goals for the antigen used in Provenge. Reduce cost of goods.Leading the high throughput screening development activities with the use of robotics for resin screening, downstream process development, clone screening and analytical characterization of proteins.Performed troubleshooting, optimization and characterization of commercial process for producing the antigen used in the Provenge process.Led the downstream process development of the antigen used for a new cancer indication (Renal Cell Carcinoma)Continuous support of Upstream for process characterization, antigen stability and clone selection.

Downstream development of protein purification processes including chromatography (various modalities), UFDF, viral filtration and inactivation, adsorbing membranes, protein refolding (post capture) and associated analytical support (HPLC-SEC, HIC, RP, DNA extraction/quantification, free sulfhydryls, etc). Generation of cGLP tox material, scale-up and transfer to the pilot scale and larger. Scale down qualification and viral validation studies.Technology development including multi-modal resins (AEX-HIC, CEX-HIC), HIC membranes, etc. High throughput screening with robotics (Tecan)

Downstream process development for protein biologics (Enbrel).Developed, modeled and scaled-up a post capture redox reactions for protein refolding. Successfully refolded misfolded and aggregated mAB at ~90% efficiency. Scaled up to pilot scale (600L) and commercial scale (1000L).