Senior QC Specialist

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).

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

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?