Job Description 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).Job DescriptionWe 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
