TATAA Biocenter 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.


Mikael Kubista, an early adopter of quantitative PCR, founded TATAA Biocenter in 2001 as a center of excellence in qPCR and gene expression analysis. It quickly became the world’s largest qPCR training provider, and later, Europe’s largest qPCR services provider. It was the first laboratory in Europe to obtain flexible ISO 17025 certification and was presented the Frost & Sullivan Award for Customer Value Leadership as Best-in-Class Services for Analyzing Genetic Material in 2013.


In recent years, TATAA researchers contributed to significant scientific achievements, such as pioneering subcellular protein profiling (2018), contributing to multicenter evaluations of microRNA extraction from blood samples and circulating cell-free DNA extraction (2019), developing GrandPerformance Sars-CoV-2 Detection kit (CE-IVD) (2020), unravelling false positive covid testing (2020) and contributing to the first single cell multi-omics profiling study (2020).


In November 2021, TATAA Biocenter was listed as one of Sweden's fastest growing tech companies by accounting organization Deloitte. “It is an impressive effort by our employees growing TATAA Biocenter from a teaching platform to one of Europe's leading companies serving the Pharmaceutical and Biotech industries. It bodes well for the efforts on cell and gene therapy and international expansion TATAA Biocenter initiated this year,” says Mikael Kubista, CEO.


TATAA recently announced the opening of a Good Laboratory Practice (GLP) compliant facility in Gothenburg, Sweden. The new facility, opened in December 2021, will specialize in quality control (QC) analytics to better support the needs of gene and cell therapeutics.


The company is situated in the center of Gothenburg and has today 46 employees.


For more information about the company, please visit https://tataa.com/

 

GLP Bioanalytical Study Director


Company: TATAA Biocenter
Position: GLP Bioanalytical Study Director
Reports to: President, Head of Commissioned Services
Location: Gothenburg, Sweden


The position as GLP Bioanalytical Study Director

GLP Study Directory has 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).

You will be the responsible person to develop study plans, ensure that resources are available, both staff and equipment, that the study plans are followed, and all generated data are fully documented and recorded. You will author Study Reports, with responsibility for the validity of the data. As a project leader, you will be the main contact person for assigned customers, provide regular updates, and maintain close communication.

The role also involves close interactions with internal stakeholders in R&D, business development, QA, other project leaders as well as external contacts with customers.

The suitable candidate will have experience from a role as GLP Study Director or similar, as well as understanding of the drug development process. Experience from qPCR and ddPCR techniques is an advantage.

You have a strong drive with the ability to take initiatives. Given the size of the company, you must have a "can do" attitude and not be afraid to roll up your sleeves. You are independent, but also like the coordinating and project leading role for a team, working toward a common goal. Strong project management and communication skills are essential to be successful in this role.


You will be a member of a dedicated team in the Commissioned Services Department, today consisting of 15 persons, and report directly to the President, Head of Commissioned Services.



Main purpose of the job

• 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

• Closely monitor and oversee 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

• Build and maintain strong relationships with internal stakeholders, consultants, vendors, and partners



Experience and qualifications

We expect the ideal candidate to have:

• Master of Science or higher in Chemistry, Molecular Biology or equivalent

• 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

• Good understanding of GLP and regulatory requirements

• Fluent in English, spoken and written

• Experienced user of MS Office package



Required skills and personal characteristics

• Deciding and initiating action – makes prompt, clear decisions and initiates and generates activity. Takes leadership.

• Excellent communication skills, both written and oral

• Project Management skills: organizational, sets clearly defined objectives, monitors performance against deadlines and milestones. Manages time effectively.

• Focuses on customer needs and satisfaction, sets high standards for quality and quantity

• Works productively in a high-pressure environment, keeps emotions under control during difficult situations. Enthusiastic with a strong drive and a flexible mindset enjoying multiple tasks



Other

The position as GLP Bioanalytical Study Director will be based in Gothenburg.


Opportunities with the role

This is an opportunity to be part of an exciting journey.

With expertise based on over two decades of experience in the nucleic acid analysis field, and supported by a state-of-the-art equipment and processes, TATAA is taking the next step in developing the company. One important milestone is the recently opened Good Laboratory Practice (GLP) compliant facility.

Being part of a small organization offers high visibility, broad responsibilities, and an opportunity to make a real impact. You will be working with a dedicated team, in an informal and personal atmosphere where everybody helps one another to reach even greater achievements together.


Contact

For inquires and more information about the position, please contact:

Catharina Herbertsson or Eva Runnerström, Senior Recruitment consultants at PeakSearch.

E: catharina.herbertsson@peaksearch.se
M: +46 706 152 772
E: eva.runnerstrom@peaksearch.se
M: +46 701 725 379


Application

Apply for the position at http://www.peaksearch.se