Moderna Therapeutics Inc.
Director, Bioanalytical and Molecular Assays
Moderna Therapeutics Inc., Norwood, Massachusetts, us, 02062
The Role:Moderna is seeking an experienced Bioanalytical and Molecular expert to join the Pre Clinical and Clinical Bioanalytical team
to oversee GLP/GCLP based bioanalyses . 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, and 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 SOPs, determination, and control of critical reagents.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.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.About ModernaSince 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.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.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.
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to oversee GLP/GCLP based bioanalyses . 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, and 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 SOPs, determination, and control of critical reagents.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.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.About ModernaSince 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.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.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.
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