What we offer
Kantisto offers a range of services, including interim management, tailored to the pharmaceutical industry. With extensive leadership expertise in analytical development, quality control, and both late-stage and early-stage development support, we provide interim management solutions that ensure smooth operations, strategic growth, and effective team development in your organization.
Whether you need leadership for a specific project, team development, or process optimization, we offer the expertise to meet your organization's needs.
Management Experience
Head of Analytical Development and Quality Control
As Head of Analytical Development and Quality Control, Ewoud van Tricht led teams focused on bioanalytical development, process development support, product characterization, and QC release for cell therapy candidates.
Key Responsibilities:
- Established and led high-performing teams for bioanalytical development, product characterization, and QC release within the cell therapy sector.
- Integrated new technologies within Analytical Development (AD) and QC teams, ensuring effective qualification and validation of new methodologies under Quality by Design (QbD) principles.
- Managed a team of ≥16 analysts and scientists, overseeing workload distribution, technical guidance, and mentorship.
- Acted as a key member of the site leadership team, collaborating with representatives from Manufacturing, QA, HR, Supply Chain, and Facilities.
- Ensured compliance with cGMP regulations, maintaining SOPs and Sanofi standards.
- Reviewed IND/IMPD filings for cellular therapy candidates for clinical use.
Team Lead / manager Analytical Development
Ewoud van Tricht provided scientific leadership in method development for release, stability, and characterization of vaccine products across all development stages. He managed a team of over 10 people, focusing on personal development, resource management, and team leadership.
Key Responsibilities:
- Managed method development for vaccine release, stability, and characterization, ensuring compliance with industry standards.
- Led and developed a team of ≥10 people, including regular performance appraisals and career development conversations.
- Organized two major leadership events for senior leaders within analytical development.
Head of Early Analytical Development
Cari Sänger led the Early Analytical Development department, overseeing a team of 16 employees across BSc, MSc, and PhD levels. She was fully responsible for both the managerial and scientific aspects of the department.
Key Achievements and Outputs:
- Provided analytical support for the pre-clinical and early clinical development of active pharmaceutical ingredients (APIs) and pharmaceutical products under GLP, GMP, and Good Science quality frameworks.
- Led method development, validation, application, and transfer processes.
- Produced CMC documentation, including specifications and source documents for IMPD-Q and IND submissions.
Strategic Contributions:
- Built and nurtured a collaborative and open atmosphere within the Early Analytical Development department, encouraging team members to contribute their expertise.
- Spearheaded the early dissolution strategy and led training initiatives across the sector to educate on the role of dissolution in biopharmaceutical drug development.
- Responsible for shaping the Science strategy within the Analytical Technology Platform.