Marc Kowalczyk, Bmeng, Mba Email & Phone Number

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.

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.

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.

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.

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.

Neuilly-Sur-Seine, Fr

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.

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.

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.

Mba Essentials, Business Administration And Management, General

Executive Mba

Engineering Degree, Mechatronics - Biomedical Engineerning

Masters, Mechatronics

Project Management