CareDx, Inc. is a leading precision medicine solutions company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers. CareDx offers products, testing services, and digital healthcare solutions along the pre- and post-transplant patient journey, and is the leading provider of genomics-based information for transplant patients.
**This position is based on-site in Stockholm, Sweden**
Are you passionate about operational excellence in a laboratory setting? We are looking for an Operational Lab Manager to lead and manage activities related to our Operational Manufacturing Lab in Stockholm, serving CareDx Lab Products with global presence in 100 countries. This is a key role ensuring high-quality production and compliance in a dynamic environment.
What You’ll Do
- Manage and plan manufacturing activities on site, ensuring efficiency and professionalism. This includes raw material qualification, manufacturing, in process- and post-production QC controls and result analysis as well as generation and review of associated documentation.
- Operate software to produce and release batch-specific components for end-user needs.
- Ensure equipment is up and running in a compliant way.
- Prepare and manage internal operational documentation and batch-specific product documentation for end-users.
- Handle deviations and CAPAs and drive continuous improvement projects.
- Participate in change management processes and lead improvement initiatives.
- Collaborate with internal teams to ensure compliance with all regulatory and company requirements.
- Provide regular status reports to management.
- Manage and develop personnel, fostering a high-performance culture.
What We’re Looking For
- Master’s degree in molecular Genetics, Molecular Biology, Medical Science or equivalent.
- Minimum 2 years of demonstrated successful management experience
- Demonstrated experience of working in a regulated environment
- Strong problem-solving skills
- Excellent communication skills in English and Swedish, both oral and written
- Personal qualities and experience are highly valued
Why Join Us?
- Be part of an innovative team driving excellence in lab operations
- Opportunity to lead impactful projects and shape processes
- Work with products with the mission to enable transplant patients to live longer and fuller lives
Additional Details:
Every individual at CareDx has a direct impact on our collective mission to improve the lives of organ transplant patients worldwide. We believe in taking great care of our people, so they take even greater care of our patients.
In addition, we have a Living Donor Employee Recovery Policy that allows up to 30 days of paid leave annually to a full-time employee who makes the selfless act of donating an organ or bone marrow.
With products that are making a difference in the lives of transplant patients today and a promising pipeline for the future, it’s an exciting time to be part of the CareDx team. Join us in partnering with transplant patients to transform our future together.
CareDx, Inc. is an Equal Opportunity Employer.
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Top Skills
What We Do
CareDx: Transforming Transplant Patient Care Through Novel Surveillance Management Solutions
CareDx, Inc. is dedicated to improving the lives of organ transplant patients through non-invasive diagnostics. By combining the latest advances in genomics and bioinformatics technology, with a commitment to generating high quality clinical evidence through trials and registries, CareDx is at the forefront of organ transplant surveillance and pre-transplant HLA typing solutions.
NASDAQ:CDNA
About AlloSure®
AlloSure is the first and only non-invasive blood test that directly measures allograft injury and identifies the probability of active rejection to better manage kidney transplant patients. AlloSure is a clinical-grade, proprietary Next-Generation Sequencing (NGS) based test to detect donor-derived cell-free DNA (dd-cfDNA) in order to identify organ injury in kidney transplant recipients. AlloSure is analytically validated as a sensitive, specific, and precise measurement of dd-cfDNA. AlloSure detects active rejection (acute active ABMR, chronic active ABMR, or TCMR) with high accuracy, outperforms serum creatinine in kidney transplant recipients, and is highly sensitive in distinguishing ABMR from no ABMR. AlloSure is performed in the CareDx CLIA-certified laboratory.
http://www.allosure.com/
About AlloMap®
AlloMap Molecular Expression Testing is a non-invasive blood test used to aid in the identification of heart transplant recipients with stable allograft function who have a low probability of moderate/severe acute cellular rejection at the time of testing in conjunction with standard clinical assessment. AlloMap testing measures the expression levels of 20 genes from a blood sample. The combined expression of these genes is represented as an AlloMap test score. AlloMap is performed in the CareDx CLIA-certified laboratory and has been commercially available in the United States since 2005. AlloMap was cleared by the U.S. Food and Drug Administration in 2008 and was CE marked for the European Union in 2011. Use of AlloMap is also included in the International Society for Heart and Lung Transplantation (ISHLT) Practice Guidelines, published in August 2010, the worldwide standard for the care of heart transplant patients.
http://www.allomap.com/
