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Scientist Bioanalytical Small Molecule information

What does a scientist bioanalytical small molecule do?

A Scientist Bioanalytical Small Molecule is responsible for developing and performing analytical methods to detect, quantify, and characterize small molecule drugs and their metabolites in biological samples. They play a critical role in drug discovery and development by ensuring the accuracy, reliability, and reproducibility of bioanalytical data. Their work supports pharmacokinetic and toxicology studies, helping to determine the safety and efficacy of new pharmaceuticals. These scientists often use techniques such as LC-MS/MS, HPLC, and other analytical instrumentation in their daily work.

What are the key skills and qualifications needed to thrive as a scientist bioanalytical small molecule?

To thrive as a Scientist in Bioanalytical Small Molecule research, you need a solid background in chemistry, pharmacology, or related fields, often supported by an advanced degree (MS or PhD) and experience with bioanalytical methods. Proficiency in techniques such as LC-MS/MS, HPLC, and using laboratory information management systems (LIMS) is typically required, along with knowledge of regulatory guidelines like GLP/GCP. Strong problem-solving, attention to detail, and communication skills help differentiate top performers in designing experiments and presenting data. These competencies are crucial to ensure accurate data generation, regulatory compliance, and effective collaboration in drug development projects.

What are some common challenges faced by a scientist bioanalytical small molecule, and how can they be addressed?

Scientists working in bioanalytical small molecule research often encounter challenges such as developing robust assays for diverse and complex compounds, maintaining data integrity under strict regulatory guidelines, and troubleshooting instrumentation issues. Addressing these challenges requires strong problem-solving skills, close attention to detail, and effective collaboration with analytical, QA/QC, and regulatory teams. Proactively staying updated on new analytical techniques and participating in cross-functional discussions can help overcome technical hurdles and ensure high-quality results.

What are popular job titles related to Scientist Bioanalytical Small Molecule jobs?

For Scientist Bioanalytical Small Molecule jobs, the most frequently searched job titles are:

Infographic showing various Scientist Bioanalytical Small Molecule job openings in the United States as of September 2026, with employment types broken down into 85% Full Time, 13% Part Time, and 2% Contract. Highlights an 92% Physical, 1% Hybrid, and 7% Remote job distribution.

Senior Scientist, Bioanalytical Sciences

Cambridge, MA

CEDENT
IT Services • 11 - 50 employees
Learn more about CEDENTexternal

$100K - $136K/yr

Full-time

Re-posted 11 days ago

Job description

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 systems
  • Develop, optimize, and qualify RT-qPCR-based assays for quantifying LNP-delivered mRNA in biological matrices
  • Develop 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 guidance
  • Collaborate with stakeholders in DMPK, Toxicology, Clinical, and Regulatory to ensure assay readiness, study support, data integrity, and reporting across GLP and non-GLP studies
  • Become a bioanalytical SME for external CROs to ensure method transfer, scientific rigor, compliance, and execution of assay development, sample analysis, and method validation/qualification
  • Review, 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 principles
  • Stay 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 considered
  • Prior contribution to IND submissions or regulatory responses related to bioanalysis
  • Experience with nucleic acid bioanalysis using RT-qPCR for quantifying mRNA or oligonucleotides in preclinical or clinical settings
  • Experience developing and qualifying ligand-binding assays (ELISA, MSD, Luminex) for protein quantification and ADA characterization
  • Experience managing outsourced bioanalytical work, including CRO oversight, protocol review, and data quality control
  • Familiarity with regulatory guidance (e.g., ICH M10) and FDA/EMA expectations for bioanalytical support of IND submissions
  • Experience with data interpretation
  • Commitment to our Core Values: Respect, Integrity, Excellence, and Impact
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About Cedent

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CEDENT strives to attract and retain the best people and provide an environment where they can all develop professionally and build a rewarding career. As a result, we create an inclusive environment that is rich in diversity, acknowledges each individual's uniqueness and promotes respect, personal achievement and stewardship. Our clients are global and so is CEDENT. We build and maintain a global workforce that includes people from different backgrounds, with a vast range of skills and experience all united by a common culture and commitment to help our clients achieve high performance. Cultivating a diverse workforce and inclusive work environment makes business sense. Our peoples varied skills are the talent engine that powers CEDENT, enabling it in turn to deliver the innovative solutions that help our clients outperform competitors.

Industry

It services

Company size

11 - 50 Employees

Headquarters location

Plano, TX, US

Year founded

2008

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