The Chemical & Analytically Development (CHAD) serves the interests through timely supply of synthetic active pharmaceutical ingredients for clinical and development needs, with responsible process and analytical R&D leading to successful regulatory approval, launch and commercialisation.
CHAD associates develop and utilise appropriate methodologies to manufacture and analyse bulk pharma chemicals in a safe, efficient, cost-effective, environmentally responsible, and GMP-compliant fashion and through application of expertise in chemistry, engineering, and Technical Life Cycle Management.
Description and Key Responsibilities :
This role has a specific focus on GMP analytical lab-based activities in the Integrated Analytical Operations team to support the local pilot plant with IPC analytical requests.
Responsible for the setup and execution of IPC methods for the monitoring of reactions in the local pilot plant. You will also support release / retest of raw materials to be used in the manufacturing.
Operate different analytical lab instruments (LC, GC, titrators, RAMAN, UV) and will be responsible for setup and maintenance of the assigned laboratory infrastructure and equipment.
Document the data generated under GMP and according to ICH standards.
Responsible for reviewing data generated from plant operators
Support training of lab and plant associates by organising ad-hoc technical training and by on-the-job training.
Work closely with analytical and process development chemists, as well as scientists and operators from a diverse range of disciplines within Chemical and Analytical Development.
Other requirements include a good technical-scientific background, good understanding of GMP, strong communication skills and the ability to work independently in a team environment.
Technician with continuing education (EU) or BS / MS or equivalent.
Minimum of 2 years hands-on relevant experience
Experience with HPLC, UHPLC and GC chromatographic systems as well as wet chemistry and a sound understanding of organic chemistry and chromatography, along with the interest in growing technically.
Strong interpersonal skills and ability to interact with colleagues from different areas, including plant associates.
Good technical skills are required, especially in the operation and maintenance of instrumentation and software.
Good understanding of GMP as well as experience in pharmaceutical development activities.
Command of English and German (spoken and written)