Michael Goers
College Station,TX
Summary
Adaptable Process Engineer in Cell Culture, Upstream Process Development, and Manufacturing Science in Technology (MSAT) seeks an opportunity for growth and enrichment. Expertise in SP2/0, MDCK, HEK293, CHO, and many other different cell lines in adherent, suspension, and microcarrier cultures. History of problem resolution, supervising junior scientists, and process optimization with ten years in the Biotech and Pharmaceutical industries.
Overview
5
5
years of professional experience
Work History
MSAT Process Engineer
Lonza Biologics
10.2021 - 03.2024
- Authored and reviewed process documentation ( SOPs, electronic batch records, change controls, investigations and deviations in Trackwise)
- Authored and reviewed quality documents (Campaign summary presentations, lot release documentation)
- Weekly interaction with clients with presentations on current progress of processes
- Technical transfer of established processes into Lonza facilities
- Supported DOE studies to establish proven and acceptable ranges
- Established PI Vision and PI Process Books models for monitoring process data
- Failure Mode Effects Analysis (FMEA) and GAP analysis authorship
- Performed Statistica analyses of Critical Quality Attributes (CQIs)
- Generated Process Models with Microsoft Vizio
Process Development Scientist II
FUJIFILM Diosynth Biotechnologies
10.2020 - 10.2021
- Worked with multitudes of different equipment suites, from Eppendorf DASGIP systems, to GE/Cytiva bioreactor systems, and to Sartorius BDCU systems.
- Execution and troubleshooting of Nova Bioprofile Flex 2 metabolite analyzers.
- Innovation work with design of experiments (JMP) for feed optimization for increased triple transfection efficiency.
- Worked with manufacturing teams to ensure processes run smoothly and adhere to cGMP requirements.
- Communicated with regulatory agencies as an SME to ensure cGMP compliance.
- Worked with Adherent, Microcarrier and Suspension Cultures for a variety of customers.
- Managing of 1-3 Junior scientists in current processes and mentoring with Cell Culture processes and techniques.
- Process Specification creation and SOP generation.
- Met with clients to report data and handle expectations of each process.
Process Technologies and Innovations Scientist
Alvotech
01.2020 - 10.2020
- Optimized ATF perfusion processes for product yield and minimum Host Cell Protein/Host Cell DNA in product
- Technical Transfer to Pilot and GMP scale.
- Protocol and SOP drafting for Development and Pilot scales.
- Incorporated Capacitance Probe technology (Biomass) to dynamically control bleed and feeds in both perfusion and fed-batch processes.
- Investigated Raman Spectroscopy on in-process bioreactors to dynamically monitor metabolite concentrations
- Planned and directing experiments on Single Use Bioreactors (Eppendorf Bioblu) at 10L scale.
- Managing several scientists to accomplish tasks required for each week.
- Line management and delegation of tasks to more junior scientists.
Upstream Process Development Expert II
Alvotech
05.2019 - 01.2020
- Operated Eppendorf BioFlo320 control towers and associated Single Use BioBlu 10C reactors.
- Reworked entire fed-batch and perfusion processes to eliminate waste and improve product yield and quality, eliminating 3 whole days of work from processes.
- Drafted Technical Summary Reports (TSR) for technical transfer to manufacturing based on our data.
- Operated Finesse glass 10L bioreactors with DeltaV software.
- Troubleshooting of processes and ATF/Finesse equipment was performed
- Ishikawa and 5-why diagram generation for deviation resolution
- Mentored and supervised junior scientists
- Design of Experiment (DOE) incorporating Quality by Design (QBD) was performed with JMP Pro 14
Education
Master of Science - Industrial Biotechnology
University of Iceland
Reykjavik, Iceland06.2021
Bachelor of Science - Biomedical Sciences
Rochester Institute of Technology
Rochester, NY06.2011
Skills
- CAPA Resolution
- Upstream Cell Culture and Process Development
- Design of Experiment (DOE) incorporating Quality by Design (QBD) with JMP
- Statistical analysis with Statistica/JMP
- MS Office suite of applications (Word, Vizio, Excel, Publisher)
- Trackwise deviations and investigations
- Technical Transfer
- Cytiva, Sartorius, Eppendorf, and Finesse proficiency
- DeltaV Recipe modification and execution
- Mentorship and supervision of junior scientists
Timeline
MSAT Process Engineer
Lonza Biologics
10.2021 - 03.2024
Process Development Scientist II
FUJIFILM Diosynth Biotechnologies
10.2020 - 10.2021
Process Technologies and Innovations Scientist
Alvotech
01.2020 - 10.2020
Upstream Process Development Expert II
Alvotech
05.2019 - 01.2020
Master of Science - Industrial Biotechnology
University of Iceland
Bachelor of Science - Biomedical Sciences
Rochester Institute of Technology