Marc Kowalczyk, Bmeng, Mba

Marc Kowalczyk, Bmeng, Mba Email and Phone Number

CTO | Medtech / Pharma / Biotech | GMP / CMC | Team Lead | Strategic Innovation | Tech Transfers @ Celeos SAS
Marc Kowalczyk, Bmeng, Mba's Location
Mulhouse, Grand Est, France, France
Marc Kowalczyk, Bmeng, Mba's Contact Details

Marc Kowalczyk, Bmeng, Mba work email

Marc Kowalczyk, Bmeng, Mba personal email

n/a
About Marc Kowalczyk, Bmeng, Mba

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.

Marc Kowalczyk, Bmeng, Mba's Current Company Details
Celeos SAS

Celeos Sas

View
CTO | Medtech / Pharma / Biotech | GMP / CMC | Team Lead | Strategic Innovation | Tech Transfers
Marc Kowalczyk, Bmeng, Mba Work Experience Details
  • Celeos Sas
    Chief Technology Officer
    Celeos Sas Jul 2023 - Present
    As 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.
  • Mkpharma Consulting
    Senior Consultant (Pm – Industrialization, Ai, Medical Devices, Biotech Automation, Regulatory)
    Mkpharma Consulting Sep 2022 - Present
    Global 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.
  • Cellprothera Sas
    R&D And Industrialization Director | Cto
    Cellprothera Sas Mar 2017 - Sep 2022
    As 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.
  • B. Braun Medical
    R&D Needle Segment Manager / Project Leader
    B. Braun Medical Jun 2012 - Mar 2017
    Bethlehem, Pa, Us
    As 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.
  • Stryker
    Industrialization / Manufacturing Engineer
    Stryker Sep 2008 - Jun 2012
    Kalamazoo, Mi, Us
    During 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.
  • Altran
    Consulting Engineer
    Altran 2008 - 2008
    Neuilly-Sur-Seine, Fr
  • P&G
    Consulting Engineer
    P&G 2008 - 2008
    Cincinnati, Ohio, Us
    Applied 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.
  • Stef-Tfe
    Transport Engineer
    Stef-Tfe 2006 - 2008
    Paris, Fr
    Tor 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.
  • Medtronic
    Consulting R&D Engineer
    Medtronic 2002 - 2002
    Minneapolis, Mn, Us
    In 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

Manufacturing Iso 13485 Medical Devices Design Control R&d Fda Capa Quality System Manufacturing Engineering Fmea Design Of Experiments V&v Minitab Amdec Manufacture U.s. Food And Drug Administration Corrective And Preventive Action Product Development Research And Development Failure Mode And Effects Analysis

Marc Kowalczyk, Bmeng, Mba Education Details

  • The London School Of Economics And Political Science (Lse)
    The London School Of Economics And Political Science (Lse)
    General
  • Quantic School Of Business And Technology
    Quantic School Of Business And Technology
    Executive Mba
  • Lodz University Of Technology
    Lodz University Of Technology
    Mechatronics - Biomedical Engineerning
  • Université D'Artois
    Université D'Artois
    Mechatronics
  • Engineering College Of Copenhagen
    Engineering College Of Copenhagen
    Project 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

Find verified emails from LinkedIn profiles
Get direct phone numbers & mobile contacts
Access company data & employee information
Works directly on LinkedIn - no copy/paste needed
Get Chrome Extension - Free

Aero Online

Your AI prospecting assistant

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.