Casper Lykke Hansen Email & Phone Number

Copenhagen, Dk

Hovedstaden, Danmark

Support ongoing activities at CMOs with special focus on late-stage manufacturing (pre-PPQ and PPQ) and commercial manufacturing• Risk assessment and Process Validation• Upscale of validated processes• CPV• Supporting, writing, and reviewing of regulatory documents. • Experience with application to both FDA and EMA• Technology Transfer• Preparation and review of control strategies• Support of root cause investigations at CMOs in connection with deviations and OOXs

Malmö, Sverige

• Process development and optimization with focus on scalability, safety and robustness of peptide APIs on solid phase.• Synthetic route scouting and selection.• Preparation, coordination and execution of development projects in the laboratory as well as pilot scale and execution of clinical Proof of Concept (PoC) synthesis of peptides on solid-phase.• Improve process understanding and impurity tracking by analytic tools such as HPLC and LC-HRMS• Development of peptide chemistry.• Technology transfer of processes from development to the production and between sites.• Production support and troubleshooting• Risk assessment and process validation.• Working according to cGMP.• Authored, reviewed and validation of documents to GMP processes.• Collaboration with key stakeholders, such as Analytical Development, Quality Assurance, Quality Control, Regulatory Affairs and Supply Chain.• Analysis of peptide and impurities using HPLC and LC-HRMS.

Kgs. Lyngby

I independently worked as synthetic chemist on an small molecules base antibiotic project in collaboration with Copenhagen University and LEO Pharma.A SAR study of new NBTI where a library of >100 compounds were synthesis and biological evaluated was performed.Keywords: Medicinal Chemistry, Drug Development, Drug discovery, MRSA antibiotics, Organic Chemistry, Organic Synthesis, Project Management.

Kgs. Lyngby

• Teaching assistant in experimental organic chemistry.• Responsibility for a lab with eight to ten students.

• Teaching assistant in statistics.• Responsibility for a class up to 30 students.

Brøndby

• Working in the in the quality assurance department.• Maintenance and trouble-shooting for analysis equipment such as flash-point measuring apparatuses.• Authored SOPs• Laboratory experience within a GMP regulated laboratory.• Worked with migration of the electronic documentation system to Microsoft Dynamics NAV and SharePoint• Responsible for obtain all necessary information on chemicals from external suppliers.

Taastrup

• Working in customer service.• Responsible for checkout counters and customer service.• Responsible for planning and coordination of checkout counters, kiosk and customer service Employees.

Doctor Of Philosophy (Ph.D.), Organic Synthesis And Medicinal Chemistry, Ph.D.

I conducted my Ph.D. studies under the supervision of Professor Thomas E. Nielsen and Professor David Tanner at DTU Chemistry. I generally.

Doctor Of Philosophy - Phd, Chemistry

Activities and Societies: Visting ScholarVisiting Scholar in the Professor David R. Spring's group. Development of synthetic strategies.

Advanced And Applied Chemistry, Synthesis And Medicinal Chemistry, M.Sc.Eng.

An education aimed at contributing to drug design and development, and which ensures competences within the below areas: • Synthetic.

Applied Chemistry, Organic Chemistry, B.Sc.Eng.

Selected courses from the bachelor’s program: • Introduction to Chemical and Biochemical Engineering • Modern Laboratory Techniques.

Htx, Kemisk Proces Teknologi