Project Director, Development product portfolio responsible for CMC and product supply. Rare Disease, CVD & Emerging Therapy Areas

CMC Project Director in rare diseases and advanced therapies

Heading up the CMC project management team and area for the development and manufacturing of monoclonal antibodies (mAb) for cancer treatment. Leadership, Operational Excellence lead, Regulatory communication. In/Out sourcing. Project Management, Customer management, Negotiations.

Leading pharmaceutical drug and api development projects of new chemical entities (peptide based).Taking ideas through preclinical development to CMC and clinical studies and finally marketed products.Building CMC parts to become a fully integrated biotech company. Analytical development responsibility and Tech transfer. Contract Research and Manufacturing Organization (CDMO/CRO/CMO) management.Preparation of regulatory documentation for EU and US / Intellectual Propery / Patents.

Principal Scientist and Senior Research Scientist for the development of anti-fungal and anti-bacterial peptides.Analytical Development for API and DP. Tech transfer, Analytical regulatory filings, support and strategies, patents and publications (IP), Sales and Marketing support. Development of novel antibiotics (Discovery). Leading global Near Infrared Spectroscopy (NIRS) & Process analytical Technology (PAT) strategy and implementation. Quality-by-Design facilitator and 6 sigma master black belt (process optimization and improvements). Linking critical material attributes of raw materials to process performance (CQA). Product and process research and development.

Project coordinator in management group reporting directly to VP. Working as expert in analytical development on API and different drug products. Implementing QbD principles. Statistical expert. Continuous improvements of project management. Six Sigma Specialist. Responsible for Six Sigma group at Lundbeck.

Research scientist working as project leader within process and product development at Novozymes Biopharma A/S. Including development of relevant analytical methodologies, product characterization, transfer of products, processes and methods, Investigation of product application areas, B2B communications, Sales and Marketing support.