Experience

Kiniksa Pharmaceuticals

• United States
• Biotechnology Research
• 100 - 200 Employee

• Director, Downstream Development and Manufacturing

  • Feb 2020 - Present

• Associate Director, Downstream Development and Manufacturing

  • Jun 2018 - Feb 2020

  • Lead construction of clinical manufacturing facility from design and build completion through to GMP vial thaw and first effort success of Phase 1 drug substance release within 6 months - Strict management of timelines, facility build and equipment spend, and agency expectations for clinical phase facility capabilities (HVAC, RODI, MOC, design, EM, testing and documentation) - Lead downstream tech transfer from external CDMO directly to at scale GMP production run in parallel to facility construction while staffing team to execute production - Hands on approach to lead team of engineers to creatively source process equipment to minimize spend, complete required equip. and facility IQ/OQ/PQ activities, and ensure first time success to enable on-time IND submission - Lead drafting of documentation for GMP production including facility and equipment SOPs, MBRs and other supporting documents including memos, investigations, deviations, and COTs aligning with Quality and Regulatory requirements • Reduced CMC spend and increased company value by reducing CDMO dependencies• Hired team of engaged, competent, and flexible engineers driven to achieve lofty company goals • Authored Module 2 and Module 3 sections for IND with positive agency feedback to initiate Ph1 trials• Lead downstream development efforts for 5 mAB assets - Ranging from Tox phase to pre-BLA activities - Guide CDMO efforts while leveraging internal capabilities for most efficient development pathway Show less



TESARO, Inc.

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Senior Manager, Downstream Development & Operations

  • May 2017 - Jun 2018

  Responsible for defining and executing CMC strategies for downstream purification process development and operations - Managed CDMO development team efforts and provided technical leadership and strategic input from downstream biologics drug substance development through to scale up and manufacturing activities - Built positive relationships through clear and frequent communication to CDMO, promoting an engaged and effective development team that consistently delivered results under aggressive CMC timelines - 3x process scale up of CHO mAb processes and tech transfer to new manufacturing facility with challenging facility fit considerations ranging from harvest centrifugation, feed stream sensitivity, and various filtration and chromatography fit considerations - Robust development of mAb and bispecific processes with creative, cost effective, and scalable purification solutions - Proficient application of late stage concepts including FMEA, DOE, statistical analyses, and parameter classifications for PPQ readiness and to meet current regulatory agency expectations Show less



Shire

• Japan
• Biotechnology Research
• 700 & Above Employee

• Senior Downstream Engineer II (MS&T, Global Product Support, Technical Services)

  • Apr 2016 - May 2017

  Technical lead for scale up of existing commercial process.External drug substance manufacturing SME.Experience with both plasma derived product processes and recombinant product processes. Successfully manage external manufacturing partners and acquired products and processes.Apply QbD principles to risk assess new and existing (acquired) products, characterize process steps, and establish meaningful and data driven PARs, NORs, acceptance criteria, and CPPs. DS process lead for complex manufacturing investigations to determine root cause, process improvements, and mitigations. Experience with multiple 2nd generation products.- CINRYZE® (C1 esterase inhibitor [human])- NATPARA® (parathyroid hormone) - RIXUBIS® (Coagulation Factor IX [Recombinant]) Show less

• Senior Downstream Development Engineer (Process Development)

  • Mar 2016 - Apr 2016

  Lead role delivering PPQ enabling characterization studies for2nd generation phase 3 program.Adherence to aggressive CMC timelines for complex project in partnership with overseasmanufacturing site.Implemented QbD initiatives to execute phase appropriate studies with subsequent processknowledge transfer.Skillful communication and management of overseas partners with the ability to balancecompany priorities while maintaining productive relationships with external stakeholders. Show less

• Senior Downstream Development Specialist (PD)

  • Jan 2013 - Feb 2016

  Downstream process development representative and SME on cross functional teams. Multiple pre-clinical, Phase 1, and Phase 3 clinical therapeutic proteins transferred both to internal plant and external manufacturing sites.Experience with CMO/CROs for process development and external tech transfer for scaled up manufacturing. Stage 1 validation and process design, QbD, process characterization, and regulatory submissions experience.Spearheaded innovative downstream processing solutions and new methods and technologies to achieve project goals. Solve complex problems while adhering to compliance requirements. Produce high quality experimental data with high throughput methods. Show less

• Process Downstream Development Specialist II (PD)

  • Jan 2010 - Jan 2013

  Early stage protein purification development, pre-clinical to Phase I. Downstream process development lead on cross functional development teams.Evaluated novel technologies to improve process development throughput. Internal tech transfer, scale up, toxicology study material production at pilot plant scale.Detailed knowledge of the science and technology for the major unit operations associated with manufacturing operations including fluid transfer, filtration, chromatography, and UF/DF processes. Document, trend, and analyze development data. Lead for introducing automated liquid handling, parallel micro-column chromatography techniques for HTS/HTPD. Show less

• Process Downstream Development Specialist I (PD)

  • Mar 2007 - Jan 2010

  Downstream purification process development, column chromatography, UFDF, viral filtration, general bioprocess purification. AKTA explorer, AKTA pilot. Process optimization, stability study design and execution.ELISA, enzymatic activity assays, SDS-PAGE, Western Blotting, UV spectroscopy, etc



AbbVie

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Purification Technician

  • Mar 2005 - Mar 2007

  Humira manufacturing plant; downstream purification through to aseptic drug substance fill operations. Humira manufacturing plant; downstream purification through to aseptic drug substance fill operations.



Advocates

• United States
• Non-profit Organizations
• 700 & Above Employee

• Mental Health Counselor

  • Sep 2003 - Mar 2005

  Provided support, counseling, medication administration, and crisis management for adult clients diagnosed with a range of mental illnesses. Provided support, counseling, medication administration, and crisis management for adult clients diagnosed with a range of mental illnesses.