The client is seeking an experienced Senior Scientist to join their Bioanalytical Sciences team. In this hands-on, lab-based role, you will lead the design, development, and execution of regulatory-aligned bioanalytical assays supporting IND-enabling studies for our mRNA-LNP therapeutics. You will be a subject matter expert in nucleic acid and protein bioanalysis, working to generate critical data that informs decision-making across preclinical and clinical development. You will be instrumental in building client’s IND readiness and advancing our genetic medicine platform. You will report into the VP, Head of DMPK and Clinical Pharmacology, with the expectation to be onsite 5 days a week. This is an individual contributor role.You will:Design and execute phase-appropriate bioanalytical strategies for mRNA-based delivery systemsDevelop, optimize, and qualify RT-qPCR-based assays for quantifying LNP-delivered mRNA in biological matricesDevelop and oversee ligand-binding immunoassays (ELISA, MSD, Luminex or similar platforms) for the detection of translated proteins and anti-drug or anti-protein antibodies, including screening, confirmatory, and neutralizing antibody assays in accordance with regulatory guidanceCollaborate with stakeholders in DMPK, Toxicology, Clinical, and Regulatory to ensure assay readiness, study support, data integrity, and reporting across GLP and non-GLP studiesBecome a bioanalytical SME for external CROs to ensure method transfer, scientific rigor, compliance, and execution of assay development, sample analysis, and method validation/qualificationReview, interpret, and present bioanalytical data to teams; contribute to the authorship of study reports, assay qualification/validation summaries, and regulatory documentation (e.g., IND Module 4/5)Ensure all analytical work is conducted in alignment with regulatory expectations and fit-for-purpose principlesStay current on emerging technologies and industry standards in nucleic acid and protein bioanalysis.Qualifications: Ph.D. in Biochemistry, Molecular Biology, Pharmaceutical Sciences, or a related field with a minimum of 5 years of industry experience; an M.S. with 8+ years of relevant industry experience will also be consideredPrior contribution to IND submissions or regulatory responses related to bioanalysisExperience with nucleic acid bioanalysis using RT-qPCR for quantifying mRNA or oligonucleotides in preclinical or clinical settingsExperience developing and qualifying ligand-binding assays (ELISA, MSD, Luminex) for protein quantification and ADA characterizationExperience managing outsourced bioanalytical work, including CRO oversight, protocol review, and data quality controlFamiliarity with regulatory guidance (e.g., ICH M10) and FDA/EMA expectations for bioanalytical support of IND submissionsExperience with data interpretationCommitment to our Core Values: Respect, Integrity, Excellence, and Impact
...required training programs.Preferred QualificationsBilingual in SpanishPrior Call Center experiencePrevious experience working from home a plusMicrosoft (MS) Windows-based applications and MS Office proficiencyEducationVerifiable High School diploma, GED, or...
KIPP is seeking a Part Time School Nurse for its Middle School in Paterson, NJ. In this role, you will provide essential health services to ensure the well-being of students and collaborate closely with staff to support student health.Qualified candidates must have a...
...On Call Banquet Server Four Seasons Hotel Westlake Village is seeking an On Call Banquet Server to join our exceptional team. In this role, you will provide outstanding service during events, ensuring guest satisfaction by delivering personalized and attentive hospitality...
...message the job poster from AgReserves, Inc. AgReserves, Inc is seeking an ethical and detail-oriented Corporate Counsel to provide legal and compliance support for AgReserves, Inc. and its domestic and international affiliated entities, including a wide variety of...
...Global Guardian protects and delivers employees and families from political, environmental, and bad actor threats worldwide. We are... ...opportunities within the organization.Position Summary and ObjectiveThe Executive Protection Agent will provide a client with physical...