Asiedua Asante
Euless
Summary
- Contribute to the Pharmaceutical industry by providing strategic technical expertise that will ensure product quality and patient supply
- BS in Chemical Engineering + MS in Biomedical Engineering with 17 years of Biotech experience
- 10+ years of Process engineering experience with Fermentation & Filtration system for Upstream process development and commercial scale operations.
- 10+ years with Drug Substance plants , manufacturing of monoclonal antibodies, cell culture-based vaccine
- SME - Subject Matter Expert with Biologics Manufacturing. Supported high volume plants as an internal consultant from corporate group for new capital and existing project support at plant level
- Involved in a large greenfield mfg. site project from start to finish of Pandemic vaccine at Novartis worth $1 Billion
- Hands-on experience with complete project cycle including, facility fit assessments, technical input for user requirements and functional specifications, startup, process validation, and regulatory filing support
- Technical Leadership experience, actively participated in and lead cross-functional teams. Managed interns and contractors to support make assess release and technology transfer activities. Served as Manufacturing Sciences and Technology (MSAT) department representative on advanced projects and/or programs.
- Able to thrive in a fast-paced Global company. Promoted to a Global role in the past 2 years. Respect for international cultures, people, languages and plant dynamics. Worked and visited plants in Japan, Singapore, South Korea, Germany, and Italy
- Excellent team player. Work well with management, engineering, project teams, quality, safety, and plant production personnel.
- Earned 27 + Employee Recognition Awards at Genentech, Roche, Novartis, GSK
- US Citizen. Single and flexible to travel to plants as needed
Overview
24
24
years of professional experience
Work History
Associate Director, Process Engineering
KITE PHARMACEUTICALS
02.2022 - Current
- Skills emphasized in this position include - communication across site functions and global senior leadership, alignment, consensus building, decision making, regulatory readiness, subject matter expert, risk management
- Timely and accurate communication across functions to ensure stakeholder alignment for project milestone decisions and stage gates.
- Lead cross-functional technology transfer team to deliver tech transfer goals by providing technical expertise, consensus building across site and global levels
- Strategy setting for technology transfer of vector manufacturing process from process development to commercial manufacturing facility
- Lead cross-functional investigation teams to troubleshoot critical quality attribute excursions that could impact the approval for health authority filings
Global Manufacturing Sciences and Technology Engineer
HOFFMAN-LA ROCHE LTD
Basel
01.2019 - 02.2022
- Company Overview: Basel, Switzerland
- Provide technical support for multiple products at different contract manufacturing organizations around the world, to ensure product supply
- Leverage company historical information and knowledge to provide lean validation packages during technology transfer and as needed during routine operations.
- Oversight on technology transfers between CMOs or from Roche to CMO.
- Authoring and reviewing technical sections for regulatory filings
- Proposed and lead lean sigma-based projects to increase efficiency to support human resource reduction.
- Process monitoring and data analysis to assess routine operations and/or troubleshoot unexpected critical quality attribute results and cell culture trends
- Basel, Switzerland
Senior Manufacturing Sciences and Technology Engineer at Plant level
HOFFMAN-LA ROCHE LTD
Basel
05.2016 - 12.2018
- Company Overview: Basel, Switzerland
- Upstream technical transfer lead for first process implementation into new Single-Use Facility in Basel Biotech. Responsible for media preparation and cell culture operations through Harvest stage. Functional responsibilities include management of cross-functional sub-team, information/communication with transferring site, and project management
- Site level representative for network initiative to reduce CAPA closure times and increase CAPA content quality. Lead a cross-functional team to implement site level CAPA review board.
- Lead for network unit operations team to support network alignment for media and buffer preparation best practices and investigations. Responsibilities include management of information databases, reviewing network impacting documentation, and collation of site-specific operational information into one searchable repository.
- Facilitate cross-functional teams to drive changes in manufacturing to meet current compliance standards.
- Provide upstream process support for process impact evaluation of discrepancies and change records.
- Serve as manufacturing technical representative on multiple global and site level technical and or unit operations teams, such as Microbial Control Action Team (global) and Material Review Board (site level)
- Support the design of small- and large-scale studies for manufacturing scale process validation, raw material supplier changes, and technology transfers for biologics.
- Basel, Switzerland
Engineer II, Manufacturing Technical Specialist III
GENENTECH, A MEMBER OF THE ROCHE GROUP
Oceanside
02.2012 - 04.2016
- Company Overview: Oceanside, CA
- Provide upstream process support for process impact evaluation of discrepancies, change records, and CAPAs
- Cross-site project lead to create strategic alignment for implementation of offline cell culture monitoring units across Genentech sites. Site project lead for $1.2 million dollar project to implement DeltaV integrated, offline cell culture monitoring devices for upstream operations
- Facilitate cross-functional team to identify, prioritize, and provide solutions to address automation related issues for cell culture/media operations, that can impact safety, compliance, and/or process
- Worked with external contractors to develop Statistics and CIP site training courses
- Served as manufacturing technical representative on multiple global and site and or unit operations team
- Led, designed, and executed bioreactor process improvement studies to increase monoclonal antibody productivity
- Managed intern to execute process validation hold time studies
- Designed and executed small scale studies to support manufacturing scale process validation for biologics.
- Coordinated execution of validation protocols at manufacturing scale
- Oceanside, CA
Process Development Engineer III, IV
NOVARTIS VACCINES & DIAGNOSTICS, Inc.
Holly Springs
10.2007 - 02.2012
- Company Overview: Holly Springs, NC
- Successfully lead cell culture technology transfer from Germany to North Carolina. Authored technical study protocols, quality risk analysis, FMEA, engineering run protocols/reports, and process validation documents. Cell Culture SME during internal audits
- Supported Quality Remediation for Flu Cell Culture process in Marburg, Germany by identifying gaps between process validation documents and quality standards
- Provided technical knowledge and recommendations to the production group to facilitate start-up of vaccine facility and troubleshooting during engineering and GMP runs
- Responsible for process mapping of production and laboratory operations at transferring site. Data gathering and analysis for process and technical assessment at transferring facility
- Lead and supported root cause analysis activities for production process related issues
- Reduced variation in the cell culture process by implementing target-based manufacturing strategy for process parameters
- Task Team Leader for technology transfer of adjuvant production process. Generated control charts and process capability analysis for adjuvant production process. Lead and facilitated FMEA and technical protocol designs. Managed contractors to complete technical study protocols, execution, and reports.
- Project Manager for BLA submission of Flu Cell Culture manufacturing process
- Lead IQP (Innovation Quality Productivity) project for designing excel spreadsheets to gather off-line manufacturing data. Project used to support application for Green Belt certification
- Lead Due Diligence project for third-party product acquisition to increase vaccines portfolio
- Holly Springs, NC
Technology Associate III
GLAXOSMITHKLINE (GSK)
King of Prussia
12.2005 - 09.2007
- Company Overview: King of Prussia, PA
- Provide technical knowledge and recommendations to the production group to facilitate quality product manufacture for hybridoma antibody production
- Responsible for writing process validation and technology transfer reports. Responsible for conducting investigative meetings and experiments to address manufacturing challenges
- Supported war room by providing documentation during PAI
- Data gathering for process and technical assessments. Created mathematical models to predict data trends for perfusion based continuous cell culture processing
- Executed lean sigma project for pH measurement consistency, using fishbone, gauge R&R, and GEMBA techniques
- King of Prussia, PA
Graduate Student
MOLECULAR MEDICINE & INFECTIOUS DISEASE
05.2004 - 12.2005
- Company Overview: Drexel University College of Medicine
- Responsible for the experimental design and development of a quantum dot-based diagnostic assay for HIV-dementia. Designed quantum dot conjugation to biomolecules as well as developed stringent hybridization conditions for identification of single nucleotide sequence variants. Duties included construction of stable cell lines, training summer students, preparing manuscripts, conference poster presentations. Attended and presented at international symposiums on HIV/AIDS
- Drexel University College of Medicine
Intern
PROCTER & GAMBLE (P&G)
Cincinnati
06.2001 - 08.2002
- Investigated production process problems for manufacture of deodorants and antiperspirants by conducting bench scale experimentation. Made recommendations for raw material specifications of major ingredients, as well as revised temperature operating windows at the plant. Worked with rheometer, dynamic mechanical analysis, and penetration tests to determine deodorant properties and crystallization temperatures.
Undergraduate Student
BIOTECHNOLOGY PROCESS ENGINEERING CENTER (BPEC)
02.2002 - 05.2002
- Company Overview: MIT
- Assessed antibody production of hybridoma mouse liver cells, while using a novel bioreactor system known as the CellFerm-Pro. Attempted to maximize antibody production by varying stir rates, glucose levels, and oxygen concentrations within 10 L scale bioreactor
- MIT
Education
MS - Biomedical Engineering
Drexel University
Philadelphia, PABS - Degree in Chemical Engineering
Massachusetts Institute of Technology (MIT)
Cambridge, MASkills
- Microsoft Office
- Statistica
- JMP
- Minitab
- LabView
Additional Information
Manufacturing representative for Genentech Oceanside OEC (2014), References available upon request
Flexibility
Flexible to travel to plants as needed
Training
- Lean Sigma
- Situational Leadership II for Managers
- Project Management
- Matrix Leadership
Awards And Activities
- Applause Employee Recognition Awards - 15 at Genentech, Roche
- Contribution Awards - 7 at Novartis
- Employee Recognition Awards 5 at GSK
- MIT Academic Awards (awards for GPA of 4.0 & above), MIT Alumni Scholarship
Personal Information
- Citizenship: US Citizen
- Marital Status: Single
Timeline
Associate Director, Process Engineering
KITE PHARMACEUTICALS
02.2022 - Current
Global Manufacturing Sciences and Technology Engineer
HOFFMAN-LA ROCHE LTD
01.2019 - 02.2022
Senior Manufacturing Sciences and Technology Engineer at Plant level
HOFFMAN-LA ROCHE LTD
05.2016 - 12.2018
Engineer II, Manufacturing Technical Specialist III
GENENTECH, A MEMBER OF THE ROCHE GROUP
02.2012 - 04.2016
Process Development Engineer III, IV
NOVARTIS VACCINES & DIAGNOSTICS, Inc.
10.2007 - 02.2012
Technology Associate III
GLAXOSMITHKLINE (GSK)
12.2005 - 09.2007
Graduate Student
MOLECULAR MEDICINE & INFECTIOUS DISEASE
05.2004 - 12.2005
Undergraduate Student
BIOTECHNOLOGY PROCESS ENGINEERING CENTER (BPEC)
02.2002 - 05.2002
Intern
PROCTER & GAMBLE (P&G)
06.2001 - 08.2002
MS - Biomedical Engineering
Drexel University
BS - Degree in Chemical Engineering
Massachusetts Institute of Technology (MIT)