Sr Scientist Bioanalytical and Molecular Assay Team
Sr Scientist Bioanalytical and Molecular Assay Team
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1 Vacancy
Job Description
The Role:
Moderna is seeking an experienced Sr. Scientist to join our Bioanalytical and Molecular Assays Team. This role involves supporting biotransformation and regulated nonclinical studies and clinical trials. A successful candidate will provide hands on experiment scientific and operational oversight of ADME pharmacokinetic (PK) lipids protein and routine biomarker bioanalyses for Moderna mRNA based therapeutic pipeline.
Heres What Youll Do:
Support establishing LCMSGLP/GCLP regulated capability and facilitate method development validation and sample analysis to support clinical and preclinical programs. Responsible for inhouse GLP/GCLP infrastructure hands on troubleshooting systems and procedures to ensure adequate rigorous laboratory practices & regulatory requirements for bioanalytical activities assuring phase appropriate approach.
Performing biotransformation experiments which include but not limited to metabolites ID mass balance protein binding and ADME investigation for Moderna mRNA based therapeutic pipeline.
Responsible for the design and of phaseappropriate clinical and preclinical analytical strategies including LCMS based assays immunoassay quantitation of lipids and therapeutic proteins lipid characterization metabolite identification and PK/PD assay method development.
Evaluate and review raw data and study analytical reports and assay validation reports as appropriate to ensure laboratories are performing analysis in compliance with current regulatory industry and Moderna standards and that data are of the required quality (regulatory and scientific).
Assist in writing SOPs regulatory submissions and in responding to regulatory queries when needed. Hands on experience in using various LIMS such as Thermo Watson Lab Vantage ELNs 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 Chemistry Biochemistry Cell Biology Immunooncology Immunology Cancer Biology or related fields with a minimum of 5 years of biotech/pharmaceutical industry experience. A B.S./M.S. with extensive bioanalytical experience will also be considered.
Strong biotransformation experience. Familiar with HRMS and metabolite ID. Knowledge in ADME of therapeutic is a plus
Experience with RNA LNP and cell therapy preferred
Track record with analytical development with deepexpertisewith bioanalyticalLCMSplatform to support PK/TKefficacy in clinical and preclinical toxicology studies
Experience with analytical method development across various platforms (e.g. ELISAMS chromatography etc. includingquantitation of lipids and therapeutic proteins in biological matrices metabolite identification and impurity profiling.
Experience managing third party assay laboratories collaborations and relevant bioanalytical vendors preferred. Strong knowledge of regulatory guidance such as BMV M10 and similar.
Demonstrated deeply understanding of global regulatory requirements including GLP GCP and the clinical trial process.
This role is expected to be in office 70 of the time with flexibility to work from home up to 30.
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:
Senior IC
Employment Type
Full-Time
