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
Quality Control Analyst
Job Description R&D Partners is seeking to hire a Quality Control Analyst II in Norton, MA . Your main responsibilities as a Quality Control Analyst II: Perform routine/non-routine an…
TECH - MAMMOGRAPHY - Full Time
Responsibilities Come and join the RMC Family! We have been in the community since 1935. Our mission is to provide comprehensive multi-specialty medical services in the greater Riverside reg…
Senior full stack software engineer
We are seeking an experienced Senior Full Stack Software Engineer to join our team responsible for supporting and enhancing critical production applications and platforms. This role is essential to m…
HHA / PCA / Homemaker -Help The Elderly Near You
Do you want a job where you make a real difference every day? Guardian Angel Senior Services is hiring Caregivers / PCAs / HHAs to help seniors remain safe, independent, and comfortable in thei…
Low Voltage Systems Specialist
Low Voltage Systems Specialist Location: Holliston, MA Country: United States Salary: $80K-$120K Start Date: Description: Our client, a leading electrical contractor with nearly 50…
Behavior Technician (Part-Time)
Title: Behavior Technician (Naturalistic, Play-Based ABA) Cortica is looking for dedicated, compassionate Behavior Technicians to join our growing team and help us design and deliver life-ch…
Executive Assistant, TEAM UP Center
Position: Executive Assistant, TEAM UP Center Location: Boston, MA Schedule: 40 hours per week, Hybrid (on-site 2-8 days per month) POSITION SUMMARY: The TEAM UP Center equips prima…
Senior Customer Marketing Manager
Senior Customer Marketing Manager Location Remote in Boston, MA : Every day, Global Payments makes it possible for millions of people to move money between buyers and sellers using our payments solut…