Director of Regulated Bioanalysis

TATAA Biocenter is Europe’s leading provider of molecular analyses services with real-time quantitative PCR, digital PCR, and Next Generation Sequencing (NGS), proteomics and single cell multiomics. We offer training in molecular methods worldwide, accredited (ISO 17025) analysis services to industry globally and technical support to academic and government laboratories primarily in Europe. We have one of the most comprehensive offerings of products for nucleic acid analyses in Scandinavia and the Czech and Slovak Republics. Our clients include pharmaceutical, diagnostic and medtech companies, and academic researchers.

ARBETSUPPGIFTER
Tasks and Responsibilities
The Director of Regulated Bioanalysis has the overall responsibility for establishing a team able to work under
He/she will also be responsible of the scientific conduct of GLP studies performed at TATAAs test facility and for confirming the compliance of these studies with OECD Principles of GLP and TATAAs quality management system (QMS).
Reporting to the head of commissioned, services, the successful candidate will:
• Work in close collaboration with QA to achieve full GLP compliance at TATAA.
• Establish a GLP team and train colleagues to GLP.
• Be responsible for qPCR and ddPCR assay development, validation and sample analysis supporting ATMP development,
• Author the Study Plans (and any amendments) ensuring that these meet the requirements of GLP.
• Be the point of contact with the Sponsor for the scientific and regulatory aspects of the studies.
• Ensure that adequate number of qualified staff is available for study conduct, the equipment is validated including computerized systems, and test items are available.
• Overview study conduct and data and ensure that all procedures are followed.
• Respond to and act on any observations made by QA during facility- or study-based inspections.
• Author the Study Report and ensure that this is a complete, true, and accurate. representation of the study and its results, thereby endorsing responsibility for the validity of the data.
• Maintain the Master Schedule for GLP studies.
• Participate in and actively suggest continual improvements of TATAA GLP-compliant QMS.
• Act as a Project Manager in other projects as directed by TATAAs management team and Head of Commissioned Services.
• Mentor and teach GLP-team members



KVALIFIKATIONER
Qualifications
• At least 5-year experience as GLP Study Director supporting regulated bioanalysis
• Highly knowledgeable with the drug development process and with GLP implementation
• Experience in SOP writing and life cycle management, as well as establishing templates for study plans, reports
• Proficiency in qPCR and ddPCR will be a plus
• Master of Science or higher in Chemistry, Molecular Biology or equivalent
• Fluent in English, spoken and written
• Excellent communicator and team player
• Ability to multitask and to work well under time pressure
• Outstanding organization skills and great attention to details


ÖVRIGT
Place of work: TATAA Biocenter, Sofierogatan 3A, Göteborg, Sweden.
We will apply an ongoing recruitment process, which means that the position can be filled before the application deadline.