Technician Drug Supply — Novartis

Full description

Salary Range

CHF56,840.00 - CHF105.560.00

Job Description Summary Location: Basel, Switzerland #onsite

Role objective

We are looking for a chemical and pharmaceutical technologist (CPT) to support the Chemical & Analytical Development (CHAD) department within Global Technical R&D (TRD). In this role, you will manufacture intermediate and drug substances (DS) for clinical care in early and late stages of development. Production is carried out in accordance with approved manufacturing regulations, SOPs, GMP and HSE requirements, and using established contamination control and cleanroom working methods. The product range includes various modalities such as synthetic oligonucleotides, peptides, classical organic agents and DS bioconjugates. Depending on the process, you work in classified production areas up to zone A, e.g. open or particularly contamination-critical process steps for low-bioburden DS/bioconjugates. We offer you a dynamic, agile environment with varied projects, high personal responsibility and development opportunities.

Job description Your responsibilities include the GMP-compliant, safe and efficient execution of manufacturing processes and the active support of a robust production operation:

• Preparation, armament and procedural provision of equipment, materials, consumables and production documents.
• Independent operation of complex process plants, systems and process-specific special plants according to PMPs, SOPs and batch strategy.
• Perform manufacturing steps for intermediates and DS, including low-bioburden and bioconjugate processes, in compliance with defined GMP, GSU, HSE and cleanroom requirements.
• Work in classified production areas up to zone A, including correct gowning, aseptically oriented work, material transfer, disinfection, line clearance and avoidance of microbial and particulate contamination.
• Ensure disciplined operation in open product handling, in particular in contamination-critical process steps such as dispensation, filtration, filling/aliquotation or other bioconjugate-relevant activities.
• Implementation and documentation of in-process controls, process observations and other production-related controls according to specifications.
• Full, timely and GMP-compliant documentation of all relevant information in the batch protocol and associated systems.
• Dismantling, cleaning, disinfection, reassembly and release preparation of process plants, equipment and work areas after production.
• Implementation of waste management activities in accordance with internal and external requirements, including exhaust air, waste water, liquid and solid waste concepts.
• Active contribution to order, cleanliness, 5S, sustainable maintenance and safe operation of production areas.
• Early detection, reporting and support in the processing of plant, process, documentation or compliance deviations.
• Introducing suggestions for improvement and solutions to optimize processes, safety, quality, cleaning processes and plant availability.
• Collaboration with process chemists, team coordination, QA, engineering, HSE, planning, warehouse and other internal stakeholders for timely and quality-compliant project implementation.
• Support and technical guidance of less experienced employees in plant operation, GMP documentation, clean room behavior, process implementation and cleaning.
• Assumption of defined special tasks according to responsibility lists, e.g. in the areas of process controls, training, shift support, plant responsibility or continuous improvement.

What you bring

• Completed training in a technical, chemical, pharmaceutical or related field (e.g. laboratory); Ideally as a chemical and