Experience

Rezolute, Inc.

• United States
• Biotechnology Research
• 1 - 100 Employee

• Senior Director of Manufacturing Sciences and Technology (MSAT)

  • Jan 2021 - Present

  Managing Contract Development Manufacturing Organization (CDMO) for Upstream and Downstream Drug substance as well as supporting Drug product manufacturing Managing Contract Development Manufacturing Organization (CDMO) for Upstream and Downstream Drug substance as well as supporting Drug product manufacturing



Samsung Biologics

• South Korea
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Associate Director (MSAT)

  • Nov 2017 - Jan 2021

  • Lead scientist responsible for management of technology transfer and manufacturing for a multi-product (Biologics), multi-client CDMO. • Transfer manufacturing technology from client to Samsung Biologics plants (1000L, 5,000L and 15,000L Bioreactors).• Perform facility fit and gap assessments between sending and receiving sites to support engineering runs, clinical runs, PPQ runs and commercial campaigns.• Identify practical solutions for a variety of tech transfer issues relating to facility fit, raw materials and aggressive timelines. Collaborate with Business Development, Supply chain, Validation, Analytical, Project Management, Environmental Health & Safety (EHS) and Manufacturing Operations. • Provide scientific leadership in process development for process optimization, process characterization, process validation, scale down model qualification and virus clearance studies. • Identify relationships between process parameters and product quality attributes.• Routinely present project progress against timelines along with challenges and risk mitigations. Provide recommendations to address risks and timeline slippage.• Author and approve technology transfer documents such as Process Control Strategy (PCS), Gap Assessment, Quality Risk Assessment (QRA, FMEA), Bill of Materials (BOM), Routine and Non-routine sampling plans, and Studies and Protocols (Process Validation, Mixing Studies, Hold Studies, Freezing Studies, etc…)• Translate technical documents from French to English as part of tech transfer.• Ensure achievement of departmental KPI’s as set forth by upper management. • Administer training and development plans to staff. Establish performance goals. Provide feedback to team.• Represent MS&T as downstream Subject Matter Expert (SME) on cross functional teams (Process Improvements, Inspections, Due Diligence, kick off meeting, etc…). Show less

• Lead Scientist MSAT

  • Jul 2017 - Jan 2021

  Manufacturing Science and Technology

• Senior Manager / Lead Engineer / Lead Investigator

  • Oct 2014 - Jul 2017

  • Lead investigator for deviations and Non-conformances to support compliance for commercial production and batch release under cGMP environment.• Conduct, manage and support investigations by performing Root Cause Analysis (PEMME, 5 Whys, 5Ms, Fish bone, …) and Impact Assessment for major deviations involving Bioburden excursions and Virus clearance risks to support clinical and commercial production and lot release under cGMP environment and CMO business.• Overseeing and managing corrective and preventive actions (CAPA) and related Change Controls by interfacing with cross-functional business teams.• Conduct risk management approach to identify potential gaps and improvement opportunities and provide recommendations on approaches to prevent and detect gaps and mitigate risks.• Responsible for downstream deviations during FDA, EMA and other regulatory agencies as well as during mock inspections by clients as part of CMO business.• Participated in FDA PLI inspection as well as EMA PLI inspection for 4 products by presenting and defending downstream deviations to inspectors.. Revise, review and approve SOPs, MBRs, QRAs ( Quality Risk Assessments), Protocols, Technical Assessments, Forms and memos as part of change control, CAPAs and investigations for non-conformances. Show less



Boehringer Ingelheim

• Germany
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Scientist

  • Mar 2011 - Sep 2014

  Key Responsibilities and Achievements: · Developed and optimized downstream purification processes for proteins, monoclonal antibodies, Biosimilars, Fab and DARPin molecules produced by CHO cells using affinity, IEX and HIC column and membrane chromatography with AKTA systems (Akta explorer, Akta purifier, Akta FPLC, Akta Avant, Akta pilot and bioprocess skids), depth filtration, TFF, viral filtration and pegylation. · Coordinated downstream activities for a DARPin molecule project produced in CHO cells to produce GLP material for animal studies. · Developed and implemented Q and HIC membrane chromatography for fast and cost effective downstream processes for antibodies as part of single use and disposable technology innovation. · Planned, led and executed viral clearance studies at contract labs. · Coordinated and managed a $40 million contract client project for downstream process development and technology transfer to manufacturing at 12,000 L production scale to support phase 2 and phase 3 Trials. · Supported downstream group in Germany for process characterization of Fab molecule using FMEA, design of experiment (DoE) and statistical prediction models to prepare for process validation and commercial launch. · Authored, co-authored. reviewed and approved protocols, batch records, SOPs, CMC sections and technical reports for downstream operations. · Hired, mentored, trainnef and supervised interns and other scientists for regular laboratory duties and other technology & innovation projects. Show less



Educational Center

• Fremont, California

• Co-founder and Chairman of the PR and Outreach Committee

  • Apr 2009 - Jun 2011

  Headed the public relations (PR) and outreach committee of the educational center. Formulated and implemented marketing campaigns and business strategies targeting specific market segments. Directed the planning and execution of fundraisings and other events to collect funds for the organization. Invited speakers and assigned topics for fundraisings, open houses and parents’ nights. Wrote, reviewed, negotiated and managed contracts between the educational centre and other companies and organizations (lease, services, purchase, collaboration and mergers). Recruited, trained, coached, motivated and evaluated the performance of staff and volunteers. Show less



Amgen

• United States
• Biotechnology Research
• 700 & Above Employee

• Senior Associate Scientist

  • Mar 2006 - Mar 2011

  Key Responsibilities & Highlights: . Earned a title of subject matter expert (SME) in downstream process development and process characterization using JMP statistical software for design of experiment (DoE) and data analysis to support Quality by Design. . Established design space for Vectibix® as part of Quality by Design (QbD) concept, which was used as an example in QbD pilot briefing document and was well received by the FDA. . Performed several product impact assessment and root cause analysis investigations for process discrepancies (Non conformances) including initiation and implementation of CAPAs (corrective and preventive actions) for commercial production and lot release. . Developed and transferred reliable resin slurry measurement method by centrifugation for packing large scale column used in commercial production as an alternative for a time consuming gravity settling method. . Supported downstream technology transfer between sites of Vectibix® a fully human antibody colon cancer drug. Managed and performed viral clearance studies for Vectibix® and supported resin life cycle viral clearance for Embrel®. . Developed, characterized and successfully implemented buffer in-line dilution technology to save space and labour by making concentrated buffers for commercial production. . Contributed to the pilot plant scale model qualification for purification to support QbD. . Authored, co-authored and reviewed reports and protocols, CMC sections and presented project updates to the department or groups within and outside the department. Show less



Abgenix Inc

• United States
• Biotechnology

• Process Development Associate III

  • Oct 2003 - Mar 2006

  Developed and optimized downstream processes for therapeutic antibodies produced using Xenomouse technology on FPLC and AKTA machines using column chromatography (Affinity, HIC, IEX, and Size Exclusion). · Planned and performed small scale as well as running large scale pilot plant processes (scale-up) including troubleshooting when necessary. · Involved in process development and technology transfer from lab scale through pilot scale to a GMP manufacturing facility of IL13 antibody by writing the process description report ensuring regulatory compliance and supporting GMP production runs. · Developed and implemented membrane chromatography technology to substitute resin chromatography as part of disposable and single-use technology within TNF antibody purification process. · Prepared and wrote SOP’s and BPRs for downstream processes and viral clearance studies. Show less



Nuvelo ( hyseq)

• Sunnyvale, California

• Research Scientist

  • Jan 2000 - Mar 2003

  - Performed Genetic sequencing DNA using qPCR technique. - Performed cell transformation and cell culture and identification of clones using PCR after transferring them from bioassay plates to 192 wells plates using Robots. . Purified and characterized recombinant proteins derived from bacterial and mammalian cell culture systems, and polyclonal antibodies from animal serum using metal chelate affinity and immuno affinity chromatography. · Hands-on experience in running Amersham/Pharmacia purification equipment (AKTA) and performing ultrafiltration and diafiltration process steps. · Performed protein analysis techniques including total protein determination by BCA, Bradford dye binding and UV absorbance, SDS-PAGE, western blot analysis, ELISA and preparing proteins for amino terminal sequence analysis on PVDF membranes. · Prepared immobilized antigen columns for the isolation of polyclonal and monoclonal antibodies to concentrate and increase the purity of the antibody preparations. Show less



Medical Laboratory sefrou Fez

• Medical Laboratory Technologist

  • Jul 1996 - Feb 1999

  . Performed most of laboratory tests in Immunology, Serology, Biochemistry, Enzymology, Hematology, Histology and Microbiology. . Microscopic identification of almost all the blood cells including the bone marrow cells. . Hands-on experience in the biology and kinetic of coagulation factors. · Manual manipulations in handling UV/VIS spectrophotometer, Bekman coulter, coagulometer, incubators and microscopes. · Preparation of solutions, reagents, buffers and growth media for cultivation of microorganisms. Hematology testing Immunology and Serology testing Microbiology identification Histology testing. Show less