Kevin Schindelwig Franca
Digital Manufacturing Systems Senior Associate at Moderna- Claim this Profile
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English Native or bilingual proficiency
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Portuguese Native or bilingual proficiency
Topline Score
Bio
Credentials
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Interpersonal Communication (2020)
LinkedInSep, 2023- Nov, 2024 -
Transitioning from Waterfall to Agile Project Management
LinkedInSep, 2023- Nov, 2024 -
High-Stakes Communication
LinkedInAug, 2023- Nov, 2024 -
Moderna AI Academy – Awareness
ModernaSep, 2022- Nov, 2024 -
Lean Six Sigma Green Belt (ICGB)
GBMP & The Northeast Lean ConferenceJul, 2022- Nov, 2024 -
Lean Six Sigma Yellow Belt (ICYB)
Corporate Education GroupJun, 2021- Nov, 2024 -
Technical Writing, Documenting Investigations, and Writing Standard Operating Procedures: Instructor Led Training
PathWiseJan, 2023- Nov, 2024
Experience
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Moderna
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United States
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Biotechnology Research
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700 & Above Employee
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Digital Manufacturing Systems Senior Associate
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Aug 2022 - Present
As a digital manufacturing systems senior associate I am tasked with digitizing our GxP documents, protocols, and procedures. Also responsible for producing digital process mapping of manufacturing and support functions as to identify gaps and area's for improvement. Also tasked with developing user dashboards to improve the manufacturing user experience and reduce time waste and delays in communications and escalation. Will also be sandbox testing available software systems to be used for… Show more As a digital manufacturing systems senior associate I am tasked with digitizing our GxP documents, protocols, and procedures. Also responsible for producing digital process mapping of manufacturing and support functions as to identify gaps and area's for improvement. Also tasked with developing user dashboards to improve the manufacturing user experience and reduce time waste and delays in communications and escalation. Will also be sandbox testing available software systems to be used for commercial operations and design a software packet that will support the development of the Moderna product pipeline from clinical manufacturing space to global commercial production.
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Co-Chair of Moderna's LGBTQ+ ERG: The Moderna Rainbow Alliance (MRNA)
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Jul 2021 - Present
Through my role on our ERG committee I help lead the ERG in promoting DE&I initiatives in support of our corporate LGBTQAI+ community. Our goal is to educate our peers and colleagues on LGBTQ and Gender identities, the political and social issues they face, and how we can all work to encourage and promote a healthy work place that is inviting and supportive of all individuals and their identities. We do this by planning internal events for our members and other employees where they can learn… Show more Through my role on our ERG committee I help lead the ERG in promoting DE&I initiatives in support of our corporate LGBTQAI+ community. Our goal is to educate our peers and colleagues on LGBTQ and Gender identities, the political and social issues they face, and how we can all work to encourage and promote a healthy work place that is inviting and supportive of all individuals and their identities. We do this by planning internal events for our members and other employees where they can learn, give back, socialize, network, and grow & develop personally and professionally. We also work together to give back to our communities through volunteerism, corporate sponsorships, and donations.
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Senior Manufacturing Associate I
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Jan 2022 - Aug 2022
Responsible for supporting large-scale production of mRNA therapeutics focusing primarily on the commercial production of the Covid-19 vaccine Spikevax® a prophylactic vaccine modality. Operating pilot bioprocessing equipment to perform mRNA processing platforms. Processing performed in strict adherence with cGMPs and aseptic processing FDA guidelines in controlled Grade B and C manufacturing areas. Other responsibilities include equipment maintenance utilizing internal systems such as OSI PI… Show more Responsible for supporting large-scale production of mRNA therapeutics focusing primarily on the commercial production of the Covid-19 vaccine Spikevax® a prophylactic vaccine modality. Operating pilot bioprocessing equipment to perform mRNA processing platforms. Processing performed in strict adherence with cGMPs and aseptic processing FDA guidelines in controlled Grade B and C manufacturing areas. Other responsibilities include equipment maintenance utilizing internal systems such as OSI PI and EMS, maintaining material inventory utilizing SAP, and completing GMP batch records IAW with established SOPs utilizing platforms such as Syncade and Veeva.
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Manufacturing Associate II at Moderna Inc.
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Jun 2020 - Jan 2022
Was responsible for supporting large-scale production of mRNA-1273, SpikeVax(R) production. Operating pilot-scale bioprocessing equipment and mixing equipment of our manufacturing platforms. Processing performed in strict adherence with cGMPs and aseptic processing FDA guidelines in controlled Grade B and C manufacturing areas. Other responsibilities include equipment maintenance utilizing internal systems such as OSI PI and EMS, maintaining material inventory utilizing SAP, and completing… Show more Was responsible for supporting large-scale production of mRNA-1273, SpikeVax(R) production. Operating pilot-scale bioprocessing equipment and mixing equipment of our manufacturing platforms. Processing performed in strict adherence with cGMPs and aseptic processing FDA guidelines in controlled Grade B and C manufacturing areas. Other responsibilities include equipment maintenance utilizing internal systems such as OSI PI and EMS, maintaining material inventory utilizing SAP, and completing GMP batch records IAW with established SOPs utilizing platforms such as Syncade and Veeva.
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Vericel® Corporation
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United States
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Biotechnology Research
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200 - 300 Employee
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Manufacturing Training Lead
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Mar 2018 - Jun 2020
Designated this role due to strong understanding of MACI manufacturing procedures and ability to train others and transfer applicable skills. Responsible for driving and directing ongoing manufacturing training to meet departmental production needs and overseeing all activities are within compliance with cGMP & FDA standards. Consulting on process development projects and coordinating transfer to manufacturing. Created methods for tracking manufacturing performance and training to… Show more Designated this role due to strong understanding of MACI manufacturing procedures and ability to train others and transfer applicable skills. Responsible for driving and directing ongoing manufacturing training to meet departmental production needs and overseeing all activities are within compliance with cGMP & FDA standards. Consulting on process development projects and coordinating transfer to manufacturing. Created methods for tracking manufacturing performance and training to identify gaps and areas for improvement with the goal of streamlining training for optimal learning. Served as an SME on MACI production at cross-functional interdepartmental meetings concerning process improvement and development. Worked directly with R&D on process development projects and new cell process and equipment validations. Work with external resources on early project development including introduction of electronic batch record system development, and production capacity growth modeling systems Oversaw transition from paper batch records to electronic batch records and developed & delivered departmental training on new electronic system Worked closely with Training Department to ensure departmental compliance with site specific cGMP, SOPs and FDA regulations. Coordinated with department schedulers to schedule meetings, and trainings based on individual needs and departmental needs. Ensured technicians remained current on trainings and annual aseptic re-qualifications. Developed and revised On the Job Training (OJT) materials, approved documents and SOPs. Mentored qualified trainers to ensure streamlined consistent department wide training. Oversaw New Hire On-boarding and initial training during contract period and evaluated performance and provided input on employee professional development. Assisted in deviation investigations and delivered trainings, and instructor led courses as CAPAs in response to deviations.
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Manufacturing Training Associate
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Sep 2017 - Mar 2018
Position Summary: The Manufacturing Training Associate is responsible for delivering cGMP, technical and organizational development training. This includes training in the areas of general and advanced knowledge of current regulations, functional job knowledge and skill development, compliance and management development in a cGMP environment. Responsible for the execution of process steps to manufacture commercial cell therapy products meeting internal and regulatory… Show more Position Summary: The Manufacturing Training Associate is responsible for delivering cGMP, technical and organizational development training. This includes training in the areas of general and advanced knowledge of current regulations, functional job knowledge and skill development, compliance and management development in a cGMP environment. Responsible for the execution of process steps to manufacture commercial cell therapy products meeting internal and regulatory requirements. Core Responsibilities: • Deliver and administer On-The-Job (OJT) training across multiple product lines in accordance with safety guidelines, cGMPs and SOPs. • Work with the Manufacturing team to evaluate personnel training needs and participate in the development and delivery of training materials. • Schedule personnel for the appropriate qualifications such as Gowning, Aseptic Technique, Personnel Qualifications (PQs). • Deliver New Hire training and identify needs / solutions for on-going training. • Collect and provide data for monthly department training metrics. • Participate on training projects with cross functional team members. • Assist with delivery/training setup for Subject Matter Experts (SMEs) delivering training (WebEx, presentations, etc.). • Manage requests and ongoing updates for learning plan requests. • Manage course evaluations and other training effectiveness tools (instructor feedback, in class evaluations, exams, etc.). • Participate in determining objectives of significant projects or assignments. • Able to understand the manufacturing processes in order to assists in reviewing and revising documents. • Assists in deviation investigations, CAPAs, risk assessments and change controls.
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Qualified Trainer
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Oct 2016 - Sep 2017
Train technicians on MACI processes using OJT Checklists Assist in developing and revising OJTs and process SOPs Assist in deviation investigations and delivering trainings, and instructor led courses in response to deviations Work with department scheduler to schedule meetings, and trainings based on individual needs and departmental needs Work closely with Training Department to ensure departmental compliance with staying current on trainings and annual… Show more Train technicians on MACI processes using OJT Checklists Assist in developing and revising OJTs and process SOPs Assist in deviation investigations and delivering trainings, and instructor led courses in response to deviations Work with department scheduler to schedule meetings, and trainings based on individual needs and departmental needs Work closely with Training Department to ensure departmental compliance with staying current on trainings and annual requalification’s Serve as a SME on MACI product at cross-functional meetings concerning process improvement and development
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Senior Manufacturing Technician
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Jul 2015 - Sep 2017
Position Overview: - Responsible for the execution of process steps to manufacture commercial cell therapy products, i.e. Carticel(autologous chondrocytes), and MACI (Matrix-induced Autologous Chondrocytes for Implantation) meeting internal and regulatory requirements. Core Responsibilities: • Perform manufacturing procedures inside class 10,000 clean room in accordance to established SOPs, cGMPs, and safety regulations. • Perform aseptic manipulations of… Show more Position Overview: - Responsible for the execution of process steps to manufacture commercial cell therapy products, i.e. Carticel(autologous chondrocytes), and MACI (Matrix-induced Autologous Chondrocytes for Implantation) meeting internal and regulatory requirements. Core Responsibilities: • Perform manufacturing procedures inside class 10,000 clean room in accordance to established SOPs, cGMPs, and safety regulations. • Perform aseptic manipulations of cell culture, final product assemblies. • Document production operations in corresponding batch records and log sheets according to cGMPs and established SOPs. • Input data from production records to existing databases. • General housekeeping of manufacturing controlled area. • Perform clean room equipment sanitization. • Record equipment metrology readings to ensure the equipment is operating within specifications. • Interact with other manufacturing groups such as QA, MTS, QC, etc. • Review completed production records for accuracy. • Organizational and planning skills and the ability to cooperate with others in a team environment will be critical to success.
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Roger Williams University
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United States
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Higher Education
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700 & Above Employee
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Peer Tutor
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Sep 2012 - May 2015
Tutor fellow undergraduates in the fields of biological life sciences, genetics, general chemistry and organic chemistry. Assisting with homework, assignments, and exam preparation.
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Resident Assistant
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Aug 2012 - May 2015
Act as a resource to undergraduates living in RWU campus housing; serving as a direct line of communication between the Department of Residence Life and Housing and the residents. Develop a dynamic community among residents in which they feel included and safe, promoting a more enriched on-campus experience by developing relationships and connections between residents. Prepare programs and plan events that allow residents to explore self-discovery and growth and which provide… Show more Act as a resource to undergraduates living in RWU campus housing; serving as a direct line of communication between the Department of Residence Life and Housing and the residents. Develop a dynamic community among residents in which they feel included and safe, promoting a more enriched on-campus experience by developing relationships and connections between residents. Prepare programs and plan events that allow residents to explore self-discovery and growth and which provide education on social issues and dynamics in addition to the academic education they receive in the classroom. Ensure resident's safety and promote healthy lifestyles by monitoring residents activities and intervening during times of emergency and immediate danger.
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Research Assistant
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Nov 2011 - May 2015
Maintain laboratory, maintain cell cultures of unicellular parasite Entamoeba, prepare media/solutions for cell cultures. Prepare growth assays of Entamoeba histolytica exposed to pyrazoline compounds, screening for inhibitory potential and anti-amoebic activity. Analyze fluorescent microscopy experiments to determine the pathogenesis of cryptic Entamoeba species. Classify Entamoeba varieties based on morphology and motility. Maintain a detailed hand-written record… Show more Maintain laboratory, maintain cell cultures of unicellular parasite Entamoeba, prepare media/solutions for cell cultures. Prepare growth assays of Entamoeba histolytica exposed to pyrazoline compounds, screening for inhibitory potential and anti-amoebic activity. Analyze fluorescent microscopy experiments to determine the pathogenesis of cryptic Entamoeba species. Classify Entamoeba varieties based on morphology and motility. Maintain a detailed hand-written record of all experiments and analytical tests. Effectively communicate results from research through oral presentations, poster presentations and through documentation with written reports, manuscripts and a final thesis. Read current literature pertaining to research projects and lead and participate in weekly group discussions about the literature and how it can be used to develop and improve our research projects.
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Research Assistant
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Sep 2014 - Jan 2015
Design and perform organic synthesis reactions in an effort to convert 2-pyrazoline compounds to pyrazole derivatives in order to probe the reactive center responsible for their anti-amoebic activity. Screen oxidation methods both thermal and microwave reactions to convert 1,3,5 trisubstituted 2-pyrazolines to corresponding 2-pyrazoles. Monitor oxidation reactions utilizing Thin Layer Chromatography (TLC) Isolate and purify products from synthetic reactions by flash column… Show more Design and perform organic synthesis reactions in an effort to convert 2-pyrazoline compounds to pyrazole derivatives in order to probe the reactive center responsible for their anti-amoebic activity. Screen oxidation methods both thermal and microwave reactions to convert 1,3,5 trisubstituted 2-pyrazolines to corresponding 2-pyrazoles. Monitor oxidation reactions utilizing Thin Layer Chromatography (TLC) Isolate and purify products from synthetic reactions by flash column chromatography and crystallization. Verify compound structure by 1H NMR, 1C NMR and COSY NMR. Maintain a detailed hand-written record of all experiments and analytical tests. Read and familiarize oneself with current literature pertaining to oxidation methods and write a final report on the research and experimental results.
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Education
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2021 - 2025
Northeastern University
Master's degree, Biotechnology -
2011 - 2015
Roger Williams University
Bachelor's of Science, Biology/Biological Sciences, General -
2011 - 2015
Roger Williams University
Bachelor's Degree, Biology/Biological Sciences, General -
2011 - 2015
Roger Williams University
Bachelor's Degree, Chemistry -
2011 - 2015
Roger Williams University
Minor, Mathematics -
2021 -
Northeastern University
Master's degree, Biotechnology
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