George Setiabudi

Work History

Director, Chemical Development

Eiger BioPharmaceuticals, Inc.

2022.04 - 2024.03

Lead external technical teams for API, DP manufacturing and logistics for Phase 2, Phase3 and Commercial activities
Timely management of risks to supply, projects, budgets pertaining to CMC and drug manufacturing
Leading and managing cross functional teams (direct & in-direct) at CMO/CDMOs and internal teams for 3 assets simultaneously (JSC, JPT, DS, DP teams and management)
Leading JIT supply for raw materials, starting materials, API, to DP, operations and logistics for multi-million dollar contracts
Leading and coordinating cross-functional teams to resolve technical CMC manufacturing issues (risk assessments, investigations, deviation resolutions, CAPA, other quality system)
Scale up Peptide process and feasibility assessments from 5Kg to 1000Kg
Partner with multi-disciplinary teams Product, QA, ADQC, SCM and Regulatory for CMC
Support regulatory filings for FDA, EU and PMDA (author CMC sections for development and manufacturing).
Facilitated cross-functional collaboration for improved decision-making processes within the organization
Managed daily operations while overseeing multiple locations to foster increased productivity

Associate Director, External Drug Substance Manufacturing

Allakos Inc.

2021.09 - 2022.03

People leader / manager for Technical Operations, Bioprocess and overall CMC functions
FastTrack / lead technology transfer activities, process development and build robust technical operations teams
Leading and managing cross functional teams (direct & in-direct) including developing, motivating and coaching team members in-person and remotely
Technical lead for CMC activities and deliverables for internal management
CMO/CDMO management, work on both tactical and strategic supply strategy
Proven track record in innovation project management and implementation.

Independent Consultant

Hayward, CA

2018.04 - 2021.08

Advise on industry best practices to develop GLP/GMP facility
Advise on process engineering requirements for cGMP manufacturing, modular, single-use or stainless steel bioprocessing equipment
Advise on QA requirements for manufacturing and operations readiness
Advise on Supply Chain and warehousing best practices for manufacturing readiness
Perform assessments, identifying impact, risks and monitor performance or progress (protocols, risk assessments (FMEA, What If), deviation, CAPA)
Leading and coordinating projects and initiatives in multiple disciplinary teams
Supporting development, execution and monitoring of strategy and work streams
People management and project management.
Cultivated positive relationships with vendors to deliver timely and cost-effective supply of services and materials.
Managed multiple projects concurrently, ensuring timely delivery and high-quality results.

Vice President of Manufacturing and Supply Chain

LakePharma

2016.08 - 2018.03

Lead RFP, SOW for GLP/GMP client projects for process development and manufacturing readiness
Lead and perform strategic partnerships for technology development, equipment, supply agreements and contracts
Lead technical design of modular single-use GMP Phase I facility for biomanufacturing of the future concept (CDMO facility) with a working budget of over $10M
Program management, start-up CMC capabilities and manage technical teams (Process development, Analytical development, Engineering and QA)
Business Development for potential clients
Support joint collaboration project with corporate partner for technology and innovation
Start-up QA group and compliance for client projects and CDMO support
Develop Quality Systems for CMC contracting (CDMO) business
Lead and mentor direct reports and junior staff for development and innovation initiatives
Directed the successful implementation of best practice systems across multiple facilities, streamlining data management processes for better decision-making capabilities and supply chain management
Excellent verbal communication skills, enthusiasm, self-confidence, life experience, attention to details and being able to work under pressure.

Principal Engineer (Process Science – Bioprocess Engineering)

Boehringer-Ingelheim Inc.

2014.05 - 2016.08

Lead internal product Process Validation (PV) and CMC commercial product launch support for PPQ of Biosimilar monoclonal antibodies (Mab)Support RFP for external client projects (CMO operations such as technology transfers for NPI)
Lead and perform innovation technology development projects to design and manufacture continuous downstream processing
Lead and project manage (PM) analytical equipment validation IOPQ for commercial launch readiness
Support Biosimilar BLA filings from CMC perspective
Evaluated vendor proposals for equipment procurement, selecting optimal options based on cost-effectiveness and performance criteria.
Support process characterization studies for PV protocol generation
Support joint collaboration project with corporate partner for technology and innovation
Support quality audits as process SME (ex: PAI, client audits)
Problem solver for various investigations within the plant
Implemented new strategies to reduce costs and improve efficiency of engineering team.
Perform vendor quality audits with Quality Compliance teams
Utilized advanced simulation tools to optimize designs for improved performance prior to physical prototyping stages.
Conducted technical evaluations of engineering designs and test results.
Manage summer internship program for Process Science department since 2012 to present
Manage up to 10 summer interns for development and innovation initiatives
Mentoring two PhD students for development and innovation initiatives
Mentored junior engineers in best practices for problem-solving, fostering professional growth and development within the team.
Forensic SME for extraneous matter (for BDS and DP).

Sr. Bioprocess Engineer (Process Science – Bioprocess Engineering)

Boehringer-Ingelheim Inc.

2013.02 - 2014.05

New Product Introduction (NPI)
Lead plant start-up activities (process equipment design, PID, PFD, URS, RA) for a single- use 500L scale clinical manufacturing plant
Perform technology development projects (hollow fiber and ATF perfusion process)
Low Cost Low Volume (LCLV) initiatives and support innovation technology platform initiatives
Design single-use disposable technologies and integrate into existing stainless-steel plant to increase plant flexibility and efficiency (upstream and downstream equipment)
Single use Equipment Commissioning and Qualification using Integrated Commissioning & Qualification (ICQ) for newly procured equipment for clinical production
Facilitate and lead summer internship program for Process Science department.

Sr. Engineer (Process Science – Protein Science)

Boehringer-Ingelheim Inc. (formerly Amgen Inc.)

2011.03 - 2013.02

Responsible for design and creation of User Requirement Specification for upstream equipment to increase plant flexibility and efficiency for 2K and 12K Liter processes for Clinical (Phase I to III) Contract Manufacturing Organization (CMO)
Support new product introduction (NPI) activities with QA, Manufacturing and project teams
Technology transfer and scale-up from 100L scale to 2K and 12K Liter scale
Stainless steel Equipment Commissioning and Qualification using Integrated Commissioning & Qualification (ICQ) for newly procured equipment for clinical production
Performed FMEA analysis for potential failure modes for multi-product processing, process, cleaning, sterilization and product impact
Generate Raw Material specification for cGMP procurement and QC release
Design disposable and portable custom bags to increase plant flexibility and process requirements
Perform “Make a Batch” activities to assess and address risk to technology transfers for clinical and commercial products
Budget development and management for capital expenditures.

Sr. Engineer (Process Engineering)

Amgen Inc. (Formerly Abgenix, Inc.)

2006.04 - 2011.03

Performed technology transfer and scale-up of monoclonal antibody process for commercial manufacturing
Contributed to the design, procurement, commissioning and optimization of commercial scale centrifuge/skid for the receiving site
Reviewed Software Design Specification (SDS) for Delta V control system
Contributed to commercial launch of monoclonal antibody Vectibix for BLA submission
Contributed to regulatory compliance inspections for commercial international expansion (FDA, EMA, Health Canada and Mexico)
Lead and support regulatory submissions to regulatory agencies for yield and process optimization projects for large scale commercial applications (FDA and Canada)
Performed Cost Analysis (ROI) for capital projects
Performed FMEA analysis for potential failure modes for multi-product processing, process, cleaning, sterilization and product impact
Process description co-author for centrifugation and harvest
Centrifugation and harvest filtration SME
Supported Quality by Design initiatives for harvest unit operation
Led a cross functional team for the harvest unit operation during a $200 million facility expansion project to increase facility efficiency
Equipment Commissioning and Qualification using Integrated Commissioning & Qualification (ICQ) for commercial scale centrifuge as part of a facility expansion project
Performed Automation Check Out (ACO) and Functional Performance Testing (FPT) for the centrifugation process and CIP
Lead contact to Manufacturing, Quality groups for commercial technical support for upstream and downstream regarding process related excursions
Lead contact for Extraneous Matter excursions in the process and supply chain
Reviewed forensic analysis data to determine root cause and assess product impact.

Manufacturing Specialist III

Abgenix Inc.

2006.01 - 2006.04

Supported commercial launch of monoclonal antibody Vectibix
Responsible for technical commercial support for the upstream process and equipment by working in conjunction with Manufacturing, Engineering, Automation and Process Development
Supported Pilot Plant staff for upstream (bioreactors to centrifugation and harvest) development of Toxicology materials as a CMO
Cell culture optimization for growth, centrifugation optimization and harvest filtration
Lead investigator for a global investigation team consisting of QA/QC heads, Manufacturing heads and contractors for RCA, Product Impact and CAPA
Project Management for engineering Change Controls to modify process equipment for process optimization and control.

Purification Associate

Chiron Corporation

2004.09 - 2006.01

Performed RP HPLC using R&S technologies controllers, Unicorn Controllers and various chromatography technologies such as size exclusion, ion exchange and HIC for various drug purification
Performed workflows on controlled documents for the manufacture of biopharmaceutical products such as Proleukin, Betaseron, Meningococcal Vaccine and various CMO projects
Performed investigations in process deviation events for RCA and CAPA
Team Lead in Lean Manufacturing and Kaizen events for manufacturing
Member of Compliance Improvement Team to assure company-wide compliance with regulatory agencies.

General Manufacturing Manager (Media/Fermentation)

Bayer Corporation

2002.02 - 2004.08

Directed and coordinated production operations for 4 to 10 associates per shift responsible for the manufacturing and processing of rFVIII KOGENATE-FS per cGMP in a commercial facility for mammalian cell culture operations
Interacted with multiple departments to ensure successful implementation of Lean Manufacturing using techniques such as Visual Management and Just In Time inventory control systems to reduce waste (Cost of Goods) and improve client/customer relationship in the supply chain for bulk drug substance manufacturing
Interacted cross-functionally with Engineering and Maintenance departments to plan for Water for Injection (WFI) distribution and organize WFI usage across the plant
Evaluated and determined staffing, training and development needs by setting tangible goals with clear expectations for each direct report through effective leadership
Contributed to the development of production schedules and communication to the support departments, such as Engineering, Maintenance and Planning
Troubleshoot problems as they arise and communicate with all the necessary staff and departments to ensure proper corrective action(s) are taken for product quality and safety
Wrote and reviewed documents such as standard operating procedures, master production records, material and product specifications, and various technical reports in relevant Quality Systems
Ensured proper completion of process deviations were investigated and addressed in Quality Systems (TrackWise) and assisted in QA with appropriate CAPA recommendations and implementation for Manufacturing
Supported facility start-up activities for commercial production and licensing
Collaborated with Process Sciences, QA and QC for process deviations for non-conforming investigations
Managed multiple regulatory agency inspections such as Food & Drug Administration (FDA) and German Control Authority (GCA) in the manufacturing facility
Performed internal and supplier audits for compliance
Trained staff on regulations from safety (OSHA), FDA and GCA requirements for compliance adherence and enforce corporate policies
Performed Performance Qualifications (PQ) for Finn-Aqua Steam Sterilizer and sterilizing grade filter time stability validation.

Biotechnician to Assistant Supervisor (Media/Fermentation)

Bayer Corporation

1997.03 - 2002.02

Operated production equipment such as 200L fermenters, portable and fixed tanks, autoclaves, Clean In Place, Clean Out of Place, and Steam In Place through distributed control system ABB MOD 300
Prepared buffer and media solutions for manufacturing
As Assistant Supervisor, responsibilities included shift handover, document reviews, training and mentoring while maintaining production activities with minimal supervision
Enforcing cGMP and safety practices as well as troubleshooting process and/or equipment
Executed cleaning validation of product contact equipment such as Ultra Filtration skid, filter housings and process hoses during facility start-up
Supported cGMP and safety audits.

Summary

Overview

Work History

Director, Chemical Development

Associate Director, External Drug Substance Manufacturing

Independent Consultant

Vice President of Manufacturing and Supply Chain

Principal Engineer (Process Science – Bioprocess Engineering)

Sr. Bioprocess Engineer (Process Science – Bioprocess Engineering)

Sr. Engineer (Process Science – Protein Science)

Sr. Engineer (Process Engineering)

Manufacturing Specialist III

Purification Associate

General Manufacturing Manager (Media/Fermentation)

Biotechnician to Assistant Supervisor (Media/Fermentation)

Education

Bachelor of Arts - Molecular Cell Biology With Emphasis in Immunology

A.S., Biotechnology – Biomedical Sciences - undefined

Skills

Publications

Timeline

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