Paul Ballering Email & Phone Number

Heumen, Ge, Nl

Bilthoven, Utrecht, Nederland

Nijmegen Area, Netherlands

- leading the Quality Assurance department (encompassing functional areas Quality Systems & Compliance, Quality Product Group, QP Batch Release and GCP QA) within defined headcount- ensuring QMS compliance for manufacturing, testing, release, storage and transport/distribution of biological drug substances (monoclonal antibodies and antibody drug conjugates) at Byondis Nijmegen site (clinical and commercial)- ensuring quality oversight to outsourced activities (sterile drug product manufacture, ADC linker drug manufacture, analytical testing, storage and clinical packaging and labelling) (clinical and commercial)

Nijmegen Area, Netherlands

- operational and GMP compliant management of QC laboratory processes for in-process controls, release and stability testing and critical reagent management of commercial and clinical biological drug substances and drug products (monoclonal antibodies and antibody drug conjugates) from the Synthon network- creating an efficient organization with professional staff, striving for continuous improvement, using lean six sigma principles and fully aligned with the changing needs of the business

Oss, The Netherlands

- Managing a team responsible for Quality oversight on all batch related activities within the Down Stream Processing Plant (shop floor oversight including batch record review and deviation/CAPA/change management)- Ensuring compliant and timely disposition of products manufactured within the plant- Representing DSP related quality items during health authority inspections (USFDA PAI, KFDA, ANVISA, CFDA, IGJ)

Oss

- operational management of QC laboratory processes for in-process controls, release and stability testing of commercial and clinical biological drug substances and drug products (gonadotrophin and monoclonal antibody products) from the MSD Biologics network- operational management of Biologic Critical Reagents (BCR) needed during release and stability testing of products from the MSD Biologics network- creating an efficient organization with professional staff, striving for continuous improvement, using lean six sigma principles and fully aligned with the changing needs of the business- working in close collaboration with manufacturing (locally and globally), analytical development, quality, technical operations and CMC- responsible for qualification and maintenance of all GMP laboratory equipment- responsible for QC Profit and Loss account and CAPEX budget- first point of contact on QC related items during governmental (USFDA PAI, IGZ) inspections and customer audits

Oss

As part of the Quality Operations Biotech Oss organization responsible for the release (disposition) of clinically and commercially manufactured Biotech Active Pharmaceutical Ingredients (Drug Substances).

Overall Project Management for Active Pharmaceutical Ingredients in Late Stage Development (Phase III clinical up to and including market introduction) for both captive and CMO projects.

Responsible for preparative purification of peptides on manufacturing scale in regular production, development and validation stages.

Quality Management Course On Pharma And Biotech

Basc, Organic Chemistry