Marc Kowalczyk, Bmeng, Mba Email and Phone Number
Marc Kowalczyk, Bmeng, Mba work email
- Valid
- Valid
Marc Kowalczyk, Bmeng, Mba personal email
Currently holding a CTO position at Celeos - innovative medical device company in the oncology field.We combine a non-destructive in-vivo laser biopsy, molecular analysis by mass spectrometry, and an explainable real-time AI framework for detailed tissue characterization and precise definition of surgical margins. We create precision beyond doubt: A future free from surgical guesswork.I structure the R&D activity and I'm responsible for overseeing the technical and strategical direction, managing different technical and operational aspects, driving the industrialization process while ensuring compliance while ensuring the transition from R&D to the commercialization phase.I am an experienced professional in the healthcare, life sciences, and technology sectors. I have 20 years of experience in the successful lead of innovative product development in cardiovascular and spine stabilization for the world's biggest MedTech and biotech companies. Covering all aspects of product development including process development, scale-up/down, new technology evaluation, technology transfers, integrations and outsourcing, process validations and equipment qualifications, clinical batch manufacturing, quality and regulatory systems including IMPD, IND, CMC, and participation in the strategic planning, fundraising, scientific and technology surveillance for steady industrial growth and IP protection.
Celeos Sas
View-
Chief Technology OfficerCeleos Sas Jul 2023 - PresentAs Celeos' Chief Technology Officer (CTO), I lead our R&D&I efforts aligning them with our strategic goals. My responsibilities include team leadership, innovation management, project oversight, performance tracking, industrialization, contract negotiation, and setting up industrial partnerships to drive our innovation. -
Senior Consultant (Pm – Industrialization, Ai, Medical Devices, Biotech Automation, Regulatory)Mkpharma Consulting Sep 2022 - PresentGlobal Project Management in Medical Device development, Regulatory Advice and Submissions: 510k (FDA) and CE marking (ISO13485, MDD to MDR change), CMC support, process transfers to CDMOs, process scaling, GMP validations.
-
R&D And Industrialization Director | CtoCellprothera Sas Mar 2017 - Sep 2022As Director of Development and Industrialization at CellProthera biotech company, I lead a strong R&D team in the research, development of new ATMP drugs through an allogeneic approach for post-MI heart regeneration and knee cartilage regeneration. Additionally, I manage an industrialization team that develops an industrial stem cell expansion platform with innovative patented solutions for Regenerative Medicine and Cell therapy. My tasks also involve participating in setting the Company's Strategy & Business Development, Project Management and IP Management.
-
R&D Needle Segment Manager / Project LeaderB. Braun Medical Jun 2012 - Mar 2017Bethlehem, Pa, UsAs a Project Leader, I industrialized vena cava filters, venous access devices, and Huber needles as well as other products. It involved designing, CE/FDA/ANSM filing (510k, Gamp 5, ISO 13485), DMF, router, biocompatibility, and freedom-to-operate assessments, clinical trials, and other activities.As Needle Segment Manager I have designed and industrialized venous access device needles. The challenge was to successfully establish a mode of transfers of european solutions onto Malaysian production ground through cultural differences, frequent travels, and a complex hierarchical company backbone. Participated in strategic plant development, process layout and improvements, process and product verification and validations as well as investments and budgeting. -
Industrialization / Manufacturing EngineerStryker Sep 2008 - Jun 2012Kalamazoo, Mi, UsDuring 4 fruitful years at Stryker, with a multidisciplinary team, through a transverse projects matrix, I conducted many successful product industrialization and technology transfers from the R&D "drawing boards" to upscaled robust manufacturing of spine stabilization implants.Participated in the well-accomplished creation of a technology transfers unit to fill a newly-created manufacturing complex in China. -
Consulting EngineerAltran 2008 - 2008Neuilly-Sur-Seine, Fr -
Consulting EngineerP&G 2008 - 2008Cincinnati, Ohio, UsApplied heuristic and out-of-the-box approach for efficient and pinpoint solutions to quality issues on P&G world's fastest continuous cinematic production lines. I managed the CAPA analysis, brainstorming solutions and implementation of preventive actions. -
Transport EngineerStef-Tfe 2006 - 2008Paris, FrTor TFE Traceability & online truck and warehouse flux management was a key factor to support their steady growth and give them a tool to become the market leader. Jointly with IT dept defined and implemented on site a tailer made software that got TFE from paper to computer way of managing their product flux. -
Consulting R&D EngineerMedtronic 2002 - 2002Minneapolis, Mn, UsIn charge of developing a urological catheter for tetraplegic patients. A timely and well executed, four students, Life science, Professional 6mo Project with market analysis, quality by design, IP search, QFD and product positioning.
Marc Kowalczyk, Bmeng, Mba Skills
Marc Kowalczyk, Bmeng, Mba Education Details
-
The London School Of Economics And Political Science (Lse)General -
Quantic School Of Business And TechnologyExecutive Mba -
Lodz University Of TechnologyMechatronics - Biomedical Engineerning -
Université D'ArtoisMechatronics -
Engineering College Of CopenhagenProject Management
Frequently Asked Questions about Marc Kowalczyk, Bmeng, Mba
What company does Marc Kowalczyk, Bmeng, Mba work for?
Marc Kowalczyk, Bmeng, Mba works for Celeos Sas
What is Marc Kowalczyk, Bmeng, Mba's role at the current company?
Marc Kowalczyk, Bmeng, Mba's current role is CTO | Medtech / Pharma / Biotech | GMP / CMC | Team Lead | Strategic Innovation | Tech Transfers.
What is Marc Kowalczyk, Bmeng, Mba's email address?
Marc Kowalczyk, Bmeng, Mba's email address is ma****@****ahoo.fr
What schools did Marc Kowalczyk, Bmeng, Mba attend?
Marc Kowalczyk, Bmeng, Mba attended The London School Of Economics And Political Science (Lse), Quantic School Of Business And Technology, Lodz University Of Technology, Université D'artois, Engineering College Of Copenhagen.
What skills is Marc Kowalczyk, Bmeng, Mba known for?
Marc Kowalczyk, Bmeng, Mba has skills like Manufacturing, Iso 13485, Medical Devices, Design Control, R&d, Fda, Capa, Quality System, Manufacturing Engineering, Fmea, Design Of Experiments, V&v.
Free Chrome Extension
Find emails, phones & company data instantly
Aero Online
Your AI prospecting assistant
Select data to include:
0 records × $0.02 per record
Download 750 million emails and 100 million phone numbers
Access emails and phone numbers of over 750 million business users. Instantly download verified profiles using 20+ filters, including location, job title, company, function, and industry.
Start your free trial