Director, Bioanalytical and Molecular Assays at ModernaTX, Inc.

Posted in Other 13 days ago.

Location: Norwood, Massachusetts





Job Description:

The Role:



Moderna is seeking an experienced Bioanalytical and Molecular experts to join the Pre Clinical and Clinical Bioanalytical team to oversee GLP/GCLP based bioanalysis. A successful incumbent will provide Scientific and operational oversight of pharmacokinetic (PK) bioanalyses conducted at internal regulated assay laboratories for Moderna pipeline.



Here's What You'll Do:



  • Leads the Bioanalytical team for the clinical and preclinical safety and defines science-driven, phase appropriate, and risk-based analytical development strategies to support the development candidate during advancing clinical development stages.


  • Oversee LC-MS GLP/GCLP regulated capability and facilitate method development and validation to support lipid quantitation, protein characterization, Metabolite Ids for clinical and preclinical programs. Responsible for in-house GLP/GCLP infrastructure, systems and procedures to ensure adequate rigorous laboratory practices & regulatory requirements for analytical activities assuring phase appropriate approach.


  • Responsible for the design and execution of phase-appropriate clinical and preclinical analytical strategies including immunoassay, quantitation of lipid and therapeutic proteins, lipid characterization, metabolite identification and PK/PD assay method development.


  • Responsibilities include analytical equipment procurement/qualifications, preparation and maintenance of SOP's, determination, and control of critical reagents for example.


  • 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).


  • Select, qualify, manage, and audit external CROs located globally.


  • Assist in writing regulatory submissions and in responding to regulatory queries when needed.


  • Stay abreast of literature, 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. Knowledge of LIMS systems such as Thermo Watson, Lab Vantage and others.


  • Limited travel for vendor audits and training





Here's What You'll Bring to the Table:





  • Ph.D. in chemistry, biology, biochemistry or related field and 12+ years of experience


  • Experience with RNA, LNP and cell therapy preferred


  • Track record with analytical development with deep expertise with bioanalytical LC-MS platform to support PK/TK, efficacy and toxicology studies in preclinical models


  • Experience with analytical method development, across various platforms, (e.g., NGS, PCR, ELISA, MS, chromatography, etc.) including quantitation of therapeutic proteins in biological matrices, metabolite identification and impurity profiling.


  • Experience managing third party assay laboratories, collaborations, and relevant bioanalytical vendors preferred.


  • Demonstrated understanding of global regulatory requirements including GLP, GCP and the clinical trial process.





Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:



  • Highly competitive and inclusive medical, dental and vision coverage options

  • Flexible Spending Accounts for medical expenses and dependent care expenses

  • Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities

  • Family care benefits, including subsidized back-up care options and on-demand tutoring

  • Free premium access to fitness, nutrition, and mindfulness classes

  • Exclusive preferred pricing on Peloton fitness equipment

  • Adoption and family-planning benefits

  • Dedicated care coordination support for our LGBTQ+ community

  • Generous paid time off, including:
    • Vacation, sick time and holidays
    • Volunteer time to participate within your community
    • Discretionary year-end shutdown
    • Paid sabbatical after 5 years; every 3 years thereafter

  • Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents

  • 401k match and Financial Planning tools

  • Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options

  • Complimentary concierge service including home services research, travel booking, and entertainment requests

  • Free parking or subsidized commuter passes

  • Location-specific 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 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.


As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office 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.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 contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)


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