CBC Process Expert

Healthcare Businesswomen’s Association; Basel; Vor Ort; CHF 74.000 - 138.000; Vollzeit

Benefits dieser Stelle

Hybrid working options

Competitive benefits package

Parental leave 14 weeks

Zusammenfassung

Novartis in Basel is seeking a highly capable specialist to lead cell bank lifecycle management and to act as the primary technical and regulatory contact for shared manufacturing activities. The role focuses on GMP-compliant operations, quality documentation, and cross-functional collaboration to ensure timely execution and continuous improvement.

The candidate will drive training, investigation activities, and risk-based improvements while ensuring compliance with global regulations and site

Qualifikationen

• Excellent interpersonal & communication skills.
• Fluent in English and German.
• BSc. in Engineering, Pharmaceutical Technology, Chemistry, Pharmacy or equivalent scientific degree.
• Minimum 3 years' GMP manufacturing process support experience.

Aufgaben

• Lead lifecycle management of cell banks including inventory, manufacturing, qualification and compliance.
• Act as primary technical and regulatory contact for cell bank activities.
• Provide real-time shop floor support, troubleshoot issues and implement corrective actions.
• Ensure GMP-compliant manufacturing execution and maintain production documentation.
• Drive training, qualification and capability development of production teams.
• Lead deviation, CAPA, and root-cause investigations; ensure continuous improvement.
• Maintain regulatory compliance through quality systems, change controls and audits.
• Monitor product/process performance and drive improvements.

Kenntnisse

Interpersonal skills

English & German

Analytical thinking

Communication skills

Ausbildung

BSc in Engineering/Pharma

Jobbeschreibung

Salary Range

CHF74,200.00 - CHF137,800.00

Job Description Summary

Provide front line expert support for all process-specific issues to production in Basel BDSS Cell Bank Center, to ensure execution of processes on-time, continuously improving in quality and productivity, performed in compliance to cGMPs, SOPs and applicable guidelines and functional standards (e.g. HSE, NOSSCE).

Act as a Subject Matter Expert and support Large Molecule Platform and other customers (eg. External Supply Operations, Quality, Novartis Technical Operations Supply Chain, etc) on Cell Banks management procedures.

Job Description

• Major accountabilities:
• Lead the lifecycle management of cell banks, ensuring availability, inventory control, manufacturing, qualification, registration, and compliance with global regulatory requirements and product registrations.
• Act as the primary technical and regulatory contact for cell bank and manufacturing activities, coordinating with global functions, development teams, manufacturing sites, and external stakeholders.
• Serve as Subject Matter Expert (SME) for assigned products and processes, providing real-time shop floor support, troubleshooting technical issues, and ensuring rapid implementation of corrective actions.
• Ensure timely and GMP-compliant execution of manufacturing operations, including batch monitoring, batch record review, process validation, changeovers, and maintenance of production documentation.
• Drive training, qualification, and capability development of production teams by designing, delivering, and supporting technical training and qualification programs.
• Lead deviation, complaint, OOS/OOE, CAPA, and root cause investigation activities, ensuring effective resolution and continuous process robustness.
• Maintain inspection readiness and regulatory compliance by overseeing quality systems, change controls, validation and qualification activities, GMP documentation, and interactions with health authorities and auditors.
• Monitor and improve product and process performance through trend analysis, CPV, APQR/OPV contributions, KPI reporting, risk assessments, and implementation of process improvements.
• Manage cross-functional projects, technology transfers, process changes, equipment investments, and technical documentation, ensuring delivery on time, within budget, and in compliance with cGMP and HSE requirements.
• Champion Quality, HSE, and Operational Excellence culture by promoting continuous improvement, 5S practices, compliance oversight, supplier and contractor governance, and overall quality and safety performance across the manufacturing organization.

Essential requirements

• BSc. in Engineering, Pharmaceutical Technology, Chemistry, Pharmacy or equivalent scientific degree.
• Minimum 3-year experience in process support role on the shop floor of GMP manufacturing.
• Excellent knowledge of Upstream processes using mammalian cells. Very good understanding of cell bank processes (manufacturing, testing, and storage).
• Excellent interpersonal & communication skills.
• Fluent in English and German.

Rewards

At Novartis, we're committed to reimagining medicine together - and rewarding the people who make it happen.

The rewards of being part of our team go far beyond base pay and incentives. We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs. In addition, we provide flexible and hybrid working options, where possible, and a minimum of 14 weeks paid parental leave.

Expected Annual Base Salary Range for role: CHF 74.200 - 137.800

The salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically.

In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters. Further details will be provided during the application process.

Pay equity is a fundamental principle of our employment policy and reflects our commitment to create a diverse, equitable and inclusive environment that treats all employees with dignity and respect, as outlined in our Code of Ethics.

Read our brochure to learn more about our global total rewards offering: https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf

Note: Benefits and compensation may vary by country and are subject to local legal requirements, including provisions of collective bargaining agreements where applicable. A full overview of your compensation package, including any relevant collective bargaining agreement details applicable to your role based on your employment location and Novartis employer entity, will be communicated separately to you during the application process.

Accessibility and accommodation

Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to [e-mail] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Commitment to Diversity and Inclusion / EEO paragraph

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Skills Desired

Data Analytics