- Support and lead oversight of analytical method lifecycle during clinical and commercial stages from initial delivery through routine use, replacement and obsolescence
- Defines analytical support requirements (URS, etc) method validation strategy, method performance monitoring process, implementation strategy
- Oversees and executes method performance monitoring program (performance dashboards, trending etc), oversee and support method investigation, troubleshooting, remediation as required
- Perform method verification during compendia revision, ensure analytical methods are compliant to relevant compendia
- Support investigation of laboratory exceptions and support manufacturing investigations in timely manner
- Timely monitoring/trending of data and operational key performance indicators
- Providing accurate and timely updates of activities/deliverables to Global QC and Tech Ops management with focus on compliance, cycle times, cost management and productivity
- Building/sustaining collaborative relationships within Global QC, internal partners (SC, QA, PD, etc) and external partners (CTLs, etc)
- Identify and/or remediate technical, compliance or regulatory gaps
- Authoring/reviewing submissions as required
- Responsible for all projects assigned to the team. Acts as an advisor to subordinates supervisors or staff members to meet schedules or resolve technical or operational problems. Organization support and project team participation; include managing people
- Univesity degree in relevant scientific discipline with a minimum of 10 years relevant industry experience
- Requires knowledge and proficiency in the design, execution, and validation of analytical techniques used in the laboratory such as HPLC, SDS-PAGE, Capillary Electrophoresis, Potency and Bioassays
- Ability to troubleshoot method performance and propose corrections is essential
Technical expert in multiple analytical, molecular or safety testing technologies, establishing recognition outside the company; Knowledge of theories, concepts, principles and techniques of relevant scientific areas; Proficiency in industry practices, techniques, and standards
Excellent communication, interpersonal and organizational skills; ability to prioritize work and multitask; conducts work in compliance with cGMPs, safety and regulatory requirements
As a leading global biotechnology company we have one mission every day: to lastingly improve the lives of people living with rare diseases. Crucial to our mission are our employees - our biggest asset - who enjoy a range of benefits and career opportunities, such as trainee and training programs, job rotations, apprenticeships, work-life balance (certified family friendly), company kindergarten, wellness center, cafeteria, etc. Here you can learn more about Shire in Austria.
We offer outstanding opportunities to motivated people regardless of your gender, age, skin color, ethnicity, sexual orientation or physical handicaps. Diversity is part of our success!
The minimum salary according to collective agreement for this position is € 4.094,41 gross per month (full-time); increased payment is intended; in addition we offer an attractive monetary incentive program. We are looking forward to your application.