Assist establishment of Drug Product process development infrastructure and services for parenteral drug products for clinical and commercial use
Install, qualify, and maintain equipment for process development, non-GMP manufacturing and related analytics in close alignment with current best practices and regulations
Plan and perform process development and characterization studies for liquid and lyophilized parenteral drug products of biologics (e.g. monoclonal antibodies, novel formats, ADCs, peptides) and small molecules
Document data following applicable lab procedures and current documentation practices
Act as project lead for assigned projects, being the customer's SPOC for DPS activities
Enable innovation and technical strategy projects, generate IP and contribute to scientific publications
Execute analytical tests to support formulation and process development (e.g. HPLC and CE purity methods, content by UV, identity, color, clarity and opalescence, pH, osmolality, visible particles, subvisible particles)
Manufacture non-GMP drug product samples for supportive stability studies and preclinical use (e.g. GLP tox studies) applying aseptic working techniques
Support manufacture of clinical drug supplies at GMP sites
Requirements
Science or engineering degree (PhD, MSc) in a relevant discipline, e.g. Pharmaceutical Sciences, Chemical or Biochemical Engineering, or a training on the job as lab technician, or equivalent
Work experience as a research/technical assistant in the pharmaceutical or chemical industry, preferably in process development
Understanding of Drug Product process development, and technical knowledge of handling basic analytical equipment e.g. UV-VIS, pH, osmolality
Experience with parenteral dosage forms, protein formulation and analytics and aseptic working techniques is a plus
Very good knowledge of reporting, interpretation and documentation of scientific results
Strong communication skills and ability to work independently within a team
Excellent knowledge of written and spoken English
About Lonza
Ready to shape the future of life sciences?
Additional Information
The actual location of this job is in Basel Stücki, Switzerland.
For our successful Drug Product Services (DPS) focused branch located in Basel and Stein, Switzerland, we have exciting opportunities. Become part of a group that enables its customers to meet some of the greatest challenges in patient treatment and join us by applying for the Associate Principal Scientist Process Development DP position.
What you will get:
An agile career and a dynamic work culture
An inclusive and ethical workplace
Compensation programs that recognize high performance