Principal Scientist Bioanalytical and Molecular Assay
Principal Scientist Bioanalytical and Molecular Assay
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Salary Not Disclosed
1 Vacancy
Job Description
The Role:
Moderna is seeking an experienced Principal Scientist to join our Bioanalytical and Molecular Assays team. This role involves supporting regulated nonclinical studies and clinical trials specifically focusing on the bioanalytical assessment of cell therapies and the characterization of humoral and cellular immunogenicity of mRNALNP therapeutics.
Heres What Youll Do:
Design and execute phaseappropriate clinical bioanalytical strategies including quantitation and characterization of engineered cell therapies and immunogenicity evaluations (ADA APA nAb ELISpot) of mRNALNP therapeutics. This includes method development validation and sample testing under GLP/GcLP regulations.
Lead a team to ensure timely assay development regulatorycompliant qualification or validation of assays and troubleshooting of any internal or external CRO partner issues.
Develop cellbased nAb assays cell therapy PD assays (Flow Cytometry) immune cell activation assays (ELISpot) APA and/or PD assays using technologies such as ELISA MSD Gyros multiplex LBAs and Luminexbased protein assays.
Support and facilitate method development to support Modernas portfolio including analytical equipment procurement/qualifications and preparation and maintenance of SOPs.
Hands on knowledge of various Laboratory Information Management Systems such as Thermo Watson LabVantage ELN etc. Knowledge of AI application in regulated bioanalysis is preferred.
Deep knowledge of government guidelines internal guidance on clinical trial conduct including Good Laboratory Practice (GLP) Good Clinical Practice (GCP) internal SOPs and regulations and White Papers as appropriate for clinical bioanalysis to ensure practices are consistent with regulatory expectations.
Heres What Youll Bring to the Table:
Ph.D. in Cell Biology Immunooncology Immunology Cancer Biology or related fields with a minimum of 9 years of biotech/pharmaceutical industry experience. A B.S./M.S. with extensive bioanalytical experience will also be considered.
Preferred experience with RNA biologics and cell therapy. Expert knowledge of cellbased assays including flow cytometry and ELISpot or similar methodologies for preclinical and clinical assays is required.
Ability to effectively communicate scientific concepts program objectives and data analysis within a matrix environment.
Strong understanding of GLP requirements and current industry trends and regulatory expectations associated with bioanalytical science. Deep knowledge of regulatory guidances such as BMV M10 and similar.
At Moderna we believe that when you feel your best you can do your best work. Thats why our US benefits and global wellbeing resources are designed to support youat work at home and everywhere in between.
- Bestinclass healthcare coverage plus a suite of voluntary benefit programs to support your unique needs
- A holistic approach to wellbeing with access to fitness mindfulness and mental health support
- Lifestyle Spending Accounts to personalize your wellbeing journey
- Family planning and adoption benefits
- Generous paid time off including vacation volunteer days sabbatical global recharge days and a discretionary yearend shutdown
- Savings and investment opportunities
- Locationspecific perks and extras
About Moderna
Since our founding in 2010 we have aspired to build the leading mRNA technology platform the infrastructure to reimagine how medicines are created and delivered and a worldclass 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.
As we build our company we have always believed an inperson culture is critical to our success. Moderna champions the significant benefits of inoffice collaboration by embracing a 70/30 work model. This 70 inoffice structure helps to foster a culture rich in innovation teamwork and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn contribute and make a meaningful impact.
If you want to make a difference and join a team that is changing the future of medicine we invite you to visit modernatx/careers to learn more about our current opportunities.
Moderna is a smokefree alcoholfree and drugfree 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 committed to equal employment opportunity and nondiscrimination for all employees and qualified applicants without regard to a persons 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 EVerify Employer in the United States. We consider qualified applicants regardless of criminal histories consistent with legal requirements.
Were focused on attracting retaining developing and advancing our employees. By cultivating a workplace that values diverse experiences backgrounds and ideas we create an environment where every employee can 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 contact the Accommodations team at . (EEO Employer)
#LINB1Required Experience:
Staff IC
Employment Type
Full-Time
