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Summary
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).
Summary
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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Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Full-time
Job function
* Job function
Quality Assurance
* Industries
Pharmaceutical Manufacturing
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