REQ-10058702
8月 11, 2025
Switzerland

摘要

BDSS QC Bioanalytics is responsible for bioanalytical testing of Biopharmaceuticals for late-phase development projects and commercial products. Applied analytical techniques are mainly cell-based potency assays for bioactivity determination and ELISA /qPCR for the determination of process-related impurities (e.g. host-cell proteins (HCP), residual Protein A, residual DNA).

About the Role

We are looking for a motivated Senior QC Specialist (Lab Head) to supervise the performance of  bioanalytical experiments (i.e. cell-based bioassays, ELISA and qPCR) for quality control (release, stability, and in-process control (IPC) testing) of biotech drug substances (DS) and drug products (DP) in collaboration with members of the own and cross-functional teams in a cGMP environment.  Analytical method validation and transfers will be part of the position.

Major Accountabilities of the role as Senior QC Specialist (Lab Head) include:

• Supervision of routine QC testing activities, including line unit approval of analytical records and raw data, investigations of deviations, OOE/OOS, and analytical changes

• Full compliance with regulatory and cGMP guidelines within the field of responsibility

• Support of technical project teams as analytical expert

• Performance of method validations (full ICH validation) and transfers, author of validation- and transfer protocols / -reports

• Trending and evaluation of analytical data

• Method lifecycle management for commercial products including method updates, post-approval changes, or troubleshooting

• Management and coordination of internal and external customer interfaces (e.g. testing/resource requirements, setup of service level agreements)

• Support in health authority inspections as subject matter expert (e.g. routine GMP inspections, pre-approval inspections)

• System owner of laboratory equipment and computerized systems including initial qualification and periodic maintenance/functional testing

Requirements:

• PhD or equivalent education in Biology, Biochemistry, Chemistry, or related discipline
• Several years of experience in analytics / quality control in a leadership role. Experience with Biopharmaceuticals desirable

• Thorough knowledge of cGMP requirements

• Results oriented, team player and able to work with all levels of the organization

• Strong leadership and problem solving skills. Able to identify issues and develop business-friendly solutions in line with the overall compliance

• Good knowledge of instrument qualification, quality metrics

• Experience in audits or inspections from health authorities

• Very good communication and presentation skills

• Fluent English required (oral & written); good skills in German and/or French as local site language (oral) desired

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

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Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Operations
Innovative Medicines
Switzerland
Basel (City)
Quality
Full time
Regular
No

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

REQ-10058702

Senior QC Specialist

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Quality Operations Switzerland