GLP bioanalytical study director

TATAA is a fast-growing company with two decades of history and is recently backed by a life sciences investment firm. The company is comprised of a team of scientists providing laboratory services, products and education / training services across a broad range of nucleic acid analysis technologies including PCR, NGS and proteomics. The company serves a variety of pharma, biotech and academic customers. This position offers an exciting opportunity to get involved early on in setting up TATAA for its next phase of growth.

WORK TASKS
GLP Study Directory having the overall responsibility for the scientific conduct of GLP studies performed at TATAAs test facility and confirm the compliance of these studies with OECD Principles of GLP and TATAAs quality management system (QMS).

The successful candidate will:
• Author the Study Plan (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 Operations.
• Mentor and teach GLP-team members

QUALIFICATIONS
• At least 5-year experience as GLP Study Director supporting regulated bioanalysis
• Highly knowledgeable with the drug development process
• 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
• Outstanding organization skills and great attention to details

OTHER
The position is based in Gothenburg, Sweden.