SOFIA OJA
Havukkakivi 3, Kuopio, Finland
Summary
Pharma industry professional with experience in manufacturing, science and technology related to adenoviral vector manufacturing as well as translational research focused on cell-based advanced therapies. A highly skilled professional with several years’ experience in demanding activities related to manufacturing, process validation, scale-up, tech transfer and starting material management.
Overview
12
12
years of professional experience
Work History
Process Development Scientist
FinVector Oy MSAT
Kuopio
10.2020 - Current
- Works as an upstream expert in MSAT department
- Performed technology transfer and process validation activities such as gap analyses and risk assessments, creation of process control strategies using QbD approach, writing process validation plans and summaries (PPQ)
- Essential role in manufacturing process scale-up projects as an upstream subject matter expert (SME)
- Managed cell and viral seed stocks: cell and seed stock strategies, inventory, manufacturing forecast
- Supported manufacturing operations by participating in investigations and deviation impact assessments
- Written and reviewed major and critical change control plans, project plans, summaries and risk assessments
- Established and authored several SOPs.
- Participated in reviewing biologic's license application module 3.
- Critical role in evaluation and selection of an outsourced supplier for a critical starting material: to date, has participated in three supplier quality audits as a SME
- Essential role in establishing cell cultivation and upstream processing facilities for a new GMP manufacturing facility and performing technology transfer to the new facility
- Participated in process equipment selection, purchase and qualification as a SME
- Participated in E&L assessments as an upstream SME
- Trained other SMEs and manufacturing personnel
- Facilitated gap analyses and risk assessments for other departments
Filling Operator and SME
FinVector Oy DP Manufacturing
Kuopio
02.2018 - 08.2023
- Worked as an operator and SME in aseptic filling
- Written several SOPs and batch filling records (BFRs)
- Written several filling operation-related deviations
- Experienced filling operator: participated in numerous fillings (B grade GMP facility)
- Participated in numerous media fills for different viral vector products
- Experienced in filling 2R, 4Re and 30R vials
- Improved media fill protocol in collaboration with external consultants
- Major impact in improving filling practices, documentation and training and qualification of new operators.
Manufacturing Specialist
FinVector Oy DS Manufacturing
Kuopio
03.2020 - 10.2020
- Qualified manufacturing operator (suspension and adherent bioreactors, cell cultivation and filtration)
- Performed manufacturing SME tasks: writing and reviewing deviations, change controls, SOPs and master batch records
- Performed manufacturing batch reviews
- Gained extensive process knowledge
- Performed facility monitoring reviews
- Trained and tutored new manufacturing SMEs and operators
- Participated in equipment qualifications as a manufacturing SME
Upstream Specialist
FinVector Oy DS Manufacturing
Kuopio
08.2017 - 03.2020
- Written and reviewed SOPs and BMRs, deviations and change controls
- Written project plans ans summary reports
- While working as an operator in upstream process gained full qualification to upstream manufacturing process (GMP grade C, adherent and suspension bioreactors, filtration)
- Trained new operators and technicians.
Project Researcher
Finnish Red Cross Blood Service, Advanced Cell Therapy Centre
Helsinki
03.2012 - 08.2017
- Worked as a project researcher with the PhD project
- Significant contribution to establishment of the MSC manufacturing process in the Advanced Cell Therapy Centre
- Developed animal serum-free cultivation method for Mesenchymal Stromal Cells (MSC)
- Established differentiation methods for osteogenic and adipogenic differentiation
- Established and optimized several laboratory methods for research: ELISA, telomere lenth measeurement assay (terminal restriction fragment analysis), imaging-based screening technique to detect cellular aging
- The research was connected to clinical-grade manufacturing and quality control of MSC product
- Experienced author of scientific publications and project progress reports
- Trainer for younger PhD students
- Experience in leading complex project with a team of SMEs, technicians and students
- Manufacturing of Clinical-grade Mesenchymal Stromal Cells (MSC) and impact of the manufacturing process and handling procedures to the critical quality attributes
- Recognized ability for successful project management
- Scientific achievement: development of imaging-based method for recognizing senescent cells from MSC cultures, showing the correlation with rapid cell size increase and expression of classical senescence markers. The method could be utilized for online quality control during manufacturing.
Education
Ph.D. - Integrative Life Sciences, Biotechnology
University of Helsinki
Helsinki11-2020
Master of Science - Biochemistry
Univeristy of Helsinki
Helsinki09-2012
Skills
- Strong scientific background
- Deep process knowledge and understanding from adenovirus vector manufacturing (cell culture, bioreactors)
- Strong expertise in GMP
- Project Management
- Working in agile environment
- Communication and teamwork
- Goal oriented, problem solver
- Communication and writing skills
- Lean Champion
Websites
Curriculumvitae
Process Development Scientist, FinVector Oy MSAT, 10/2020, present, 3 years 10 months, Works as an upstream expert in MSAT. Main tasks include tech transfer and process validation activities (gap analyses and risk assessments, utilization of QbD approach, writing and reviewing process control strategies, performing process validations (PPQ)), cell and viral seed stock management, providing support for manufacturing, such as investigations and impact assessments, writing major and critical change controls.
Key experience:
Essential role in establishing cell cultivation and upstream processing facilities for a new GMP manufacturing facility and performing Tech transfer to the new facility
Essential role in manufacturing process scale-up projects as an upstream SME
Critical role in evaluation and selection of an outsourced supplier for a critical starting material. To date, has participated in three supplier quality audits as a SME
Experienced project lead
Participation in E&L assessments as an upstream SME
The tasks require extensive knowledge of the process and regulatory aspects, ability to work under tight timelines with changing priorities. Lead role in many projects required good teamwork and understanding of leading people towards successful completion of the projects., Manufacturing specialist, FinVector Oy, Upstream Manufacturing, 03/2020, 10/2020, 7 months, Key responsibilities:
Performing manufacturing SME tasks such as writing and reviewing deviations, change controls, SOPs and batch records
Performing batch reviews. The tasks required extensive knowledge of the processes, various supportive functions such as EM monitoring and material management and operation as one of the manufacturing operators
Working as an upstream operator in manufacturing
Training of new SMEs and operators
Manufacturing SME responsibility of new equipment qualification, Upstream specialist, FinVector Oy, Upstream Manufacturing, 08/2017, 03/2020, 2 years 5 months, Key responsibilities:
Writing and reviewing of SOPs and BMRs, deviations and change controls
Working as an operator in Manufacturing: during Upstream specialist working period gained full qualification to upstream manufacturing process (GMP grade C, adherent and suspension bioreactors, filtration)
Training of new operators, Filling operator and SME, FinVector Oy, Drug Product Manufacturing, 02/2018, 08/2023, 5 years, 6 months, Key tasks:
Working as an aseptic filling operator and SME has been a side task during the years. My tasks included writing SOPs and batch filling records as well as writing deviations.
Experienced filling operator: participated in numerous fillings (B grade GMP facility)
Participated in numerous media fills for different products; 2R, 4Re and 30R vials
Improved media fill protocol in collaboration with external consultants
Major impact in improving filling practices, documentation and training and qualification of new operators, Project researcher, Finnish Red Cross Blood Service, Advanced Cell Therapy Centre, 03/2012, 08/2017, 5 years, 5 months, As a project researcher my tasks were tightly connected to my PhD topic: Manufacturing of Clinical-grade Mesenchymal Stromal Cells (MSC) and impact of the manufacturing process and handling procedures to the critical quality attributes.
The project included tight connection to GMP manufacturing process of MSC cell therapy product
Both basic and applied research and utilization of various laboratory techniques
Project management in a complex project with a team on 10 members (technicians, SMEs)
Writing of scientific publications
Reporting of progress, Doctor of Philosophy (Ph.D.), University of Helsinki, Doctoral Program for Integrative Life Sciences, 03/2012, 06/2020, Culture Systems and Quality Parameters for Clinical-grade Mesenchymal stromal cells, http://urn.fi/URN:ISBN:978-952-5457-53-7, 6 peer-reviewed scientific publications in high impact journals, Master of Science (MSc.), University of Helsinki, Faculty of Environmental and Biological Sciences, 08/2011, 09/2012, Biochemistry, Evaluation of cell aging from Mesenchymal Stromal Cells using a Restriction Fragment Telomere Length Measurement Analysis, Bachelor of Science (BSc.), University of Helsinki, Faculty of Environmental and Biological Sciences, 09/1999, 08/2011, Biochemistry, Chemistry (advanced studies), Physics, Life Sciences (Genetics, Physiology, Microbiology, Molecular biology), Finnish, Native, Swedish, Limited Working Proficiency, English, Full Professional Proficiency, Deep understanding and knowledge of cell biology and bioprocessing: educational background in cell biology, biochemistry and biotechnology as well as extensive experience in upstream processing of adenoviral vector manufacturing – cell culture, bioreactors and filtration., Project management: Several successfully lead complex projects in a gene therapy CDMO – projects completed on given timelines. Significant role in building new manufacturing facility and related tech transfer. Interested in learning new project management tools., Resilience to operate in agile environment with fast changing priorities., Excellent communication and writing skills. Proficient communication in English., Humanity as a project lead – I value good communication within the team and understand the value of different personalities. I believe that goodness brings more goodness and success – psychological safety creates confidence and leads better results together., Interest and knowledge in Lean and quality management; advanced studies in Industrial pharmacy during PhD studies and work-related trainings.
Recognitionsandachievements
- Company’s Most Valuable People, Continuous Excellence, 05/23/2023
- FDA BLA approval for a gene therapy Drug Product, 12/2022
- Extension for upscaled process, 04/2023
Personal Information
Title: Ph.D., Process development scientist
Timeline
Process Development Scientist
FinVector Oy MSAT
10.2020 - Current
Manufacturing Specialist
FinVector Oy DS Manufacturing
03.2020 - 10.2020
Filling Operator and SME
FinVector Oy DP Manufacturing
02.2018 - 08.2023
Upstream Specialist
FinVector Oy DS Manufacturing
08.2017 - 03.2020
Project Researcher
Finnish Red Cross Blood Service, Advanced Cell Therapy Centre
03.2012 - 08.2017
Ph.D. - Integrative Life Sciences, Biotechnology
University of Helsinki
Master of Science - Biochemistry
Univeristy of Helsinki
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