NATALIA KEMMIT
Fargo,US
Summary
With a robust background at Aldevron, I excel in production planning and process improvement, showcasing strong analytical skills and a knack for technical training. My leadership in GMP manufacturing coordination and supervision has significantly enhanced workflow efficiency and production quality, making me a pivotal asset in biomanufacturing environments.
Overview
18
18
years of professional experience
1
1
Certification
Work History
GMP Manufacturing Coordinator
Aldevron
Fargo, ND
11.2021 - 01.2025
- Devised production event plans to optimize manufacturing preparedness.
- Collaborated with pre-production planning to enhance facility and resource utilization.
- Maintained Bill of Material accuracy within the Aldevron ERP system.
- Monitored progress against deliverables and timelines, resolving technical issues promptly.
- Monitored inventory levels, placed orders for necessary supplies and tracked shipments.
- Read product processing sheets, or specification sheets, to verify adherence to specifications.
- Performed root cause analysis on production issues to identify solutions for improvement.
- Coordinated with other departments to ensure the timely delivery of materials.
GMP Manufacturing Supervisor
Aldevron
Fargo, North Dakota
04.2021 - 11.2021
- Managed scheduling for staff, ensuring adequate coverage during peak times and projects.
- Coordinated with other department supervisors to ensure smooth workflow and project alignment.
- Directed and supervised a team of 10 employees in daily operations.
- Led weekly team meetings to discuss progress, address issues, and plan future actions.
GMP Technical Lead
Aldevron
Fargo, ND
07.2020 - 04.2021
- Ensured effective purification of mRNA and DNA in downstream processes.
- Oversaw project planning within GMP manufacturing zones, ensuring adherence to compliance guidelines.
- Supported manufacturing operations and management as delegated by leadership.
GMP Biomanufacturing Operator
Aldevron
Fargo, ND
07.2018 - 06.2020
- Critically reviewed technical details and worked with internal teams to resolve issues
- Ensured appropriate progress against deliverables and timelines
- Instructed and trained personnel on manufacturing procedures, led training events for trainees on production processes
- Supported initiation and completion of deviations, non-conforming material reports, and corrective action tasks, led corrective action investigations as well as supporting tasks required for implementation of the corrective action plan
- Assisted with responses to client comments on production records
- Guided team through technical obstacles with expertise of system details
- Downstream purification of GMP DNA and mRNA
- Executed and documented of activities via batch record, maintaining GMP/GDP standards
- Segregation, line clearance, and cleaning of GMP/GMP-Source production areas
- Updated forms for GMP manufacturing and prepared manufacturing summary reports
- Followed all safety protocols and procedures
- Reported any problems or malfunctions with machines or tools immediately upon discovery
- Ensured timely completion of all production tasks
- Collaborated with operators as part of team, keeping projects on task
- Trained new operators on equipment operations
- Operated and monitored production machines, driving product quality standards
- Monitored production equipment performance, identified issues and took corrective action when necessary
- Maintained accurate records of all production activities
- Identified opportunities for continuous improvement initiatives within the department
- Reported damaged and defective products to supervisor
Biomanufacturing Operator III
Aldevron
Fargo, ND
10.2016 - 06.2018
- Downstream purification of GMP-source DNA
- Prepared manufacturing summary reports and component lists
- Updated forms for GMP-Source manufacturing
- Followed all safety protocols and procedures
- Ensured timely completion of all production tasks
- Collaborated with operators as part of team, keeping projects on task
Biomanufacturing Scientist
Aldevron
Fargo, ND
04.2012 - 09.2016
- Downstream purification of research grade DNA
- Trained new employees
- Worked on mRNA platform development project
- Prepared manufacturing reports and assisted with writing SOPs for mRNA project
- Maintained accurate records of all experimental procedures, reagents used, and results obtained
- Conducted research and development activities for products, methods, and processes
- Planned experiments, recording and analyzing findings
Certified Nursing Assistant
Villa Maria
Fargo, ND
09.2008 - 08.2011
- Assisted patients with personal hygiene tasks, such as bathing and dressing, while maintaining respect for patient privacy and dignity
- Delivered direct care to patients, assisting with bathing, feeding, and grooming tasks
- Completed daily documentation and charts regarding patient care and input reports into practice databases
Supplemental Instruction Chemistry Leader
Minnesota State University Moorhead
Fargo, MN
01.2008 - 12.2008
- Coordinated and provided leadership for supplemental sessions.
- Developed learning materials such as practice exams, study guides, and handouts for use during Supplemental Instruction sessions.
- Assisted faculty members in developing effective Supplemental Instruction programs for their classes.
- Tutored students requiring extra help and gave additional practice work to help improve concept understanding.
Math Tutor
Minnesota State University Moorhead
Moorhead, MN
01.2007 - 12.2008
- Organized group study sessions with small groups of students who needed extra help with math assignments or tests.
- Assisted students with understanding mathematical concepts such as algebra, geometry, and calculus.
- Reviewed textbooks, notes, homework assignments, quizzes, and tests with students.
Education
Bachelor of Science (B.S.) - Biochemistry
Minnesota State University Moorhead
Moorhead, MN, US05.2011
Skills
- Production planning
- Scheduling coordination
- D365 software
- Production scheduling
- Supply management
- Technical documentation
- Production methods
- Process improvement
- Technical training
- Materials estimation
- Workflow planning
- Taking inventory
- Documentation preparation
- Analytical skills
- Biology and chemistry
- Nucleic acid extraction
- Chromatography techniques
- Cell culture techniques
- Protein purification
Certification
Google Project Management Certificate, Coursera, 2021
References
- Jon Terning, Production Planning Manager, Aldevron, (320) 221-2388, jon.terning@aldevron.com
- Morgan McLean, Manufacturing Coordinator Supervisor, Aldevron, (701) 212-6632, morgan.mclean@aldevron.com
- Meagan Gelinske, Independent Consultant, MDG Consulting, LLC, (701) 680-8012, meagandeegelinske@msn.com
Volunteer Experience
Dog and Cat Volunteer, Homeward Animal Shelter, 09/01/16, 09/01/18, Fargo, ND, Volunteered at local shelter to help with feeding, grooming, and walking animals
Languages
Russian, Native
Languages
Russian
Professional
References
References available upon request.
Timeline
GMP Manufacturing Coordinator
Aldevron
11.2021 - 01.2025
GMP Manufacturing Supervisor
Aldevron
04.2021 - 11.2021
GMP Technical Lead
Aldevron
07.2020 - 04.2021
GMP Biomanufacturing Operator
Aldevron
07.2018 - 06.2020
Biomanufacturing Operator III
Aldevron
10.2016 - 06.2018
Biomanufacturing Scientist
Aldevron
04.2012 - 09.2016
Certified Nursing Assistant
Villa Maria
09.2008 - 08.2011
Supplemental Instruction Chemistry Leader
Minnesota State University Moorhead
01.2008 - 12.2008
Math Tutor
Minnesota State University Moorhead
01.2007 - 12.2008
Bachelor of Science (B.S.) - Biochemistry
Minnesota State University Moorhead
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