The Company Founders

Anna Szymanska

An accomplished pharmaceutical executive with over 20 years of leadership in Quality Control, Quality Assurance, and Compliance across small molecules, biologics, and cell and gene therapy sectors. Currently serving as a CDMO Site Head of Quality, excels in implementing phase-appropriate quality strategies and building high-performing teams to ensure compliance and operational efficiency. Extensive experience includes collaborating with regulatory bodies such as the FDA and EMA, as well as managing quality initiatives in dynamic environments. A dedicated microbiologist, passionate about enhancing patient safety and product quality through innovative quality management systems.

Key Specializations:

Quality Management Systems (QMS): Skilled in developing and implementing robust QMS to ensure consistent compliance and operational excellence.

Regulatory Compliance: Extensive experience working with FDA, EMA, and other regulatory agencies to facilitate successful inspections and submissions.

Vendor Management and Qualification: Proficient in establishing effective vendor qualification programs, including auditing and risk analysis to ensure high-quality materials and services.

Analytical Method Validation: Strong background in developing and validating analytical methods for biologics and small molecules, ensuring accuracy and reliability in testing processes. 

GMP Facility and QC Laboratory Design: Expertise in designing and qualifying GMP-compliant facilities and laboratories to meet regulatory standards.

Slawomir Szymanski, Ph.D.

A seasoned biopharmaceutical executive with over two decades of progressive experience, specializing in operational excellence, GMP compliance, and strategic leadership within the cell and gene therapy sectors. Demonstrated expertise in continuous process improvement, program management, and small molecule pharmaceutical development to GMP standards. Skilled in fostering collaborative partnerships with CDMOs, contractors, and vendors, with a proven track record of managing complex projects and driving operational efficiencies.

Key Specializations:

Continuous Process Improvement: Six Sigma Black Belt Certified in Lean Manufacturing, driving efficiency and quality improvements across operational processes.

GMP Cell and Gene Therapy Operations: Extensive experience in designing, constructing, and managing GMP facilities dedicated to cell and gene therapy production, ensuring compliance with FDA, EMA, and other regulatory standards.

Program Management: Proficient in planning, budgeting, and leading multidisciplinary teams to achieve organizational goals, with a focus on quality-driven outcomes and timeline adherence.

Small Molecule Pharmaceutical Development: From research and development through to commercialization under GMP regulations, including oversight of manufacturing and regulatory filings.

Collaborative Engagement: Strong interpersonal skills facilitating effective collaboration with CDMOs, contractors, vendors, and clients, ensuring seamless project execution and client satisfaction.

Proven ability to build and maintain strong relationships with clients and contractors, fostering long-term partnerships built on trust and mutual success.

Oumar Diouf, MBA

A highly motivated Senior Biotechnology Professional with extensive experience in manufacturing, operations, and process development within the biotechnology and pharmaceutical sectors. Demonstrates a proven ability to transition technologies from pre-clinical to clinical manufacturing, lead technical transfers to Contract Manufacturing Organizations (CMOs), and optimize process flows for regulatory compliance and cost-effective production. Leadership roles have encompassed strategic planning, laboratory expertise, and quality management, contributing to the successful development and commercialization of innovative therapies.

Key Specializations:

Operational Leadership: Oversees facility and equipment management, manufacturing processes (internal and CMO), and supply chain logistics.

Strategic Planning for Drug Development: Develops and executes strategic plans for drug development from preclinical stages to clinical trial manufacturing.

Laboratory Expertise: Extensive experience in developing cGMP compliant T-cell therapies and cell culture techniques.

Clinical and Regulatory Affairs: Actively participates in planning and preparing regulatory submissions and clinical study protocols.

Quality Management: Engages with Quality Systems for validation, monitoring, and quality control processes.