Senior Scientist, Bioanalytical Sciences (Cambridge, MA)
- 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.
- 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
Recommended Jobs
Market Financial Center Manager - North Shore Market
At Bank of America, we are guided by a common purpose to help make financial lives better through the power of every connection. We do this by driving Responsible Growth and delivering for our …
Group 08-82 | SRP Intern | Laser Technology & Applications | Summer 2026
When NASA made history in 2013 with the longest laser communication link ever demonstrated (from a Moon-orbiting satellite to Earth), our group was behind the satellite's laser transmitter and the…
Team Optometrist - 32 hour work week with full salary!
Job Description Job Description City Eye Optometry seeks a talented optometrist to join its ever growing team! Company Description City Eye Optometry is a trusted provider of quality eye…
Caregiver for Elderly - Non-medical - Over 45 encouraged to apply
Job Description Job Description Are you an active senior looking for meaningful part-time work? Have you taken care of a family member or have a volunteer's heart? Seniors Helping Seniors® matc…
QA Operations Specialist
Job Title : Quality Assurance Operation Specialist FLSA Classification : Professional, Exempt Work Location : Fall River, MA Work Hours: General: 8:30AM - 5…
Private Client Advisor II
At Bank of America, we are guided by a common purpose to help make financial lives better through the power of every connection. We do this by driving Responsible Growth and delivering for our …
Office Administrator
Job Description Job Description Must have 5 years of experience working as a office Administrator * experience with accounts receivable * experience with accounts payable * experience wi…
DevOps Engineer
At Wizards of the Coast, we connect people around the world through play and imagination. From our genre-defining games like Magic: The Gathering® and Dungeons & Dragons® to our growing multiverse, w…
Caregiver
Caregivers needed to provide care in Southbridge ,,Sturbridge ,Webster ,Dudley Brimfield,Brookfield and surrounding areas. Must be willing to work at least one weekend day .Night shifts also availab…
RN - Post Anesthetic Care
We are seeking a dedicated RN for the PACU (Post Anesthetic Care Unit) in Worcester, MA, offering $2,345/week. Responsibilities include Monitoring patients' recovery from anesthesia and surgery …