Major Accountabilities

1. Laboratory & Technical Operations

• Perform laboratory and pilot-scale work in compliance with applicable GxP regulations, SOPs, HSE, ISEC, and Novartis guidelines.
• Maintain accurate, complete and up-to-date laboratory documentation, including proper archiving of records.
• Contribute to the creation, maintenance and continuous improvement of laboratory instructions, SOPs and templates.
• Support qualification, calibration and routine maintenance of laboratory and pilot equipment, including related documentation.
• Contribute to the evaluation and implementation of new laboratory and pilot-scale equipment.
• Evaluate, optimize and implement state-of-the-art laboratory methods and technologies; contribute to method development and reproduction of published methods.
• Represent own area of responsibility during health authority inspections.
• Assess the patent landscape with respect to project-specific questions.

2. Project Stewardship (for assigned projects)

• Design, execute and document scientific experiments (e.g. formulation, analytical testing) supporting process transfer, process improvement and process validation activities.

3. Validation & Compliance (for assigned projects)

• Prepare and review GxP-relevant documentation, including change requests.
• Support the maintenance of Quality Risk Assessments (QRAs).
• Contribute to defining and maintaining control strategies based on Critical Quality Attributes (CQAs) and, where applicable, Critical Process Parameters (CPPs) and Critical Material Attributes (CMAs) to support Ongoing Process Verification (OPV).
• Document and report results in line with regulatory and internal quality standards.

4. Launch & Technology Transfer (for assigned projects)

• Participate in technology transfer activities from laboratory to pilot and industrial scale.
• Plan and execute experiments supporting production trials and method transfers; document outcomes in technical reports.
• Actively support the transfer of analytical and manufacturing procedures to pilot plant or production.
• Provide scientific and organizational support for assigned project tasks.
• Participate in process characterization activities on behalf of Technical Development, where applicable.

5. Manufacturing Excellence & Continuous Improvement

• Identify improvement opportunities for existing processes and propose scientifically sound business cases.
• Design, execute and interpret experiments in alignment with development manuals to meet project timelines and quality targets.
• Ensure delivery of defined cost and efficiency benefits.
• Support root cause investigations for deviations, OOS and OOT by designing and executing experiments and interpreting data results.

6. Training & Knowledge Management

• Develop, maintain and expand technical know-how within the area of responsibility.
• Own and maintain the training curriculum for the role and any direct reports (if applicable).
• Provide technical training to manufacturing personnel using laboratory and pilot facilities.
• Participate in relevant internal and external manufacturing and MS&T networks.

Key Performance Indicators (KPIs)

• Full adherence to GxP, HSE and compliance standards with no critical audit observations.
• Timely delivery of project milestones and technical deliverables.
• Compliance with development manuals and quality documentation standards.
• Quality, clarity and timeliness of technical and scientific reports.
• Successful and timely execution of technology transfers.
• Effective cross-functional collaboration with stakeholders (Engineering, Production, Quality, etc.).

Impact on the Organization

• Direct contribution to MS&T objectives and overall Production Unit (PU) performance.
• Supports robust, compliant and efficient manufacturing processes across product lifecycle stages.

Ideal Background

Education & Qualification

• Bachelor’s or Master’s degree in Chemistry, Pharmaceutical Sciences, Biologics or a related natural science discipline.

Relevant Experience

• Preferably ~3 years of experience in a pharmaceutical environment (laboratory, production or development).
• Solid scientific or technical knowledge in at least one relevant domain (e.g. analytical, galenical, synthetic, biotechnological).
• Knowledge of safe handling of chemicals, equipment and potentially hazardous materials.
• Familiarity with laboratory and technical tools.
• Good communication and basic presentation skills.

Languages

• Fluent written and spoken English.
• Proficiency in the local site language.