The Role:
Moderna is seeking a talented, experienced and motivated Senior Scientist/group leader to join the Clinical Immuno-Assay group to serve as a scientific expert and point of contact for the biomarker assay development, qualification/ validation to support programs across multiple therapeutic areas.
The Senior Scientist will lead a team of Research Associate Scientists to develop, qualify and validate ligand binding based biomarker assays, and subsequently direct the clinical samples analysis in a regulated laboratory at Moderna.
The candidate will have broad knowledge of best practices in bioanalytical assay procedures, and prior experience in running assay validation and conducting data acquisition on clinical specimen. In addition, the candidate will be responsible for the training of junior team members when and where needed to perform analytical work and maintain clinical testing continuity. The ability to effectively communicate across multi-disciplinary teams and external partners is key to the role. The candidate will stay aware of the newest technology and critical reagents in his/ her field of expertise. The candidate should be outstanding scientist, collaborative team members, excellent communicator to support Moderna’s portfolio needs.
The individual will work closely with research associates to develop analytical methods and characterization tools in support of our clinical phase studies. The position will report to the Director of Immuno-Assay.
Here's What You’ll Do:
Be responsible for the overall quality and integrity of assigned bioanalytical projects in support of clinical trials at Moderna
Lead assay development, qualification/validation and sample analysis on a variety of platforms (ELISA, MSD, Ella, Hamilton…)
Deliver high quality data within defined timelines and aligned to current industry expectations
Lead data analysis with technical staff
Author and review bioanalytical reports
Identify and resolve quality issues and report issues to upper management
Serve as a Subject Matter Expert (SME) in a multifunctional project team
Represent the bioanalytical function on project teams and present results, data interpretation, timelines etc. at project meetings
Collaborate with internal and external stakeholders to evaluate new bioanalytical technologies and solutions to support challenging project requests
Occasionally the job may require overtime work or weekend shift as needed
Coach and train junior staff
Assess direct reports’ strengths and development needs and assign projects accordingly
Perform periodic performance review and communicate effectively with direct reports.
Always ensure staff compliance with safety and regulatory guidelines. Maintain training records
Attending technical conferences and exhibits as required
Here’s What You’ll Bring to the Table:
Ph.D. with2+ years or MSc with 4-6 years’ experience in bioanalysis or related field preferably in a regulated environment for biomarker analysis
Flexibility with changing priorities and urgent project requests
Strong level of understanding and expertise in design and executing ligand binding based bioanalytical methods
Expertise in best practices recommended by FDA, CLSI to conduct development, qualification and validation of assays (e.g. M10 Bioanalytical Method Validation)
Higher level of independence and strong leadership skills
Excellent written, presentation and interpersonal communication skills; ability to influence and collaborate in a team environment
Strong computational skills, preferably experienced with Word, Excel, Power Point, GraphPad Prism
Knowledge of system software for data analysis: Gen 5, EP evaluator, and basic laboratory statistics
Experience with LIMS system (e.g. Labvantage
Understanding of current GCLP or CAP/CLIA/ISO standards
Experience with Multiplex immunoassay is preferred
Experience with bioanalytical assays for vaccine development and infectious disease is preferred
Experience with cell-based neutralization assay is preferred
Experience with cell culture, ex vivo assays and cell isolation from tissues is preferred
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, theinfrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.
By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!
Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com . (EEO/AAP Employer)
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