Scientist, Bioanalytical & Molecular Assays, Centralized Bioanalytical Outsourcing

Role Summary

The Scientist will support protein quantification and proteomics analysis using Mass spectrometry for PK and PD studies, ensuring timely and efficient management of critical reagents used in the development, validation, and execution of bioanalytical and molecular assays to support clinical assays. The successful candidate will work closely with cross-functional teams for protein analysis, qualify critical reagents, and establish robust systems for monitoring, tracking, and storage. This is an in-person laboratory-based position located in Norwood, MA.

Responsibilities

• Support LC-MS based protein quantification/proteomics assay development, validation and sample analysis under regulatory compliance.
• A solid background in modern analytical techniques used in the analysis of mRNA-based therapeutic products is essential.
• Maintain a robust system for the monitoring, tracking, and storage of critical reagents to ensure their availability and quality. Support reagent characterization to generate CoA documentation.
• Knowledge of peptide/proteins, aptamer-antibody based conjugation systems for DNA, RNA, and Protein/antibodies.
• Maintain a database of Reference standards/reagents, including their specifications, source, usage, and expiration dates.
• Conduct regular audits of critical reagent inventory and work with cross-functional teams to manage the procurement and disposition of the reagents.
• Vendor management to ensure the availability and quality of critical reagents.
• Develop and implement policies, procedures, and training programs to ensure compliance with regulatory requirements and industry best practices.
• Collaborate with cross-functional teams to develop reagent-specific risk assessments and mitigation strategies.
• Monitor industry trends and advancements in critical reagent management and implement the best practices to improve efficiency and effectiveness.

Qualifications

• Required: Ph.D. in a scientific field, such as chemistry, biochemistry, or biology with 3+ years of experience in Bioanalytical Sciences/regulated bioanalysis. M.S. with at least 7 years of bioanalytical experience will also be considered.
• Required: Strong knowledge of critical reagents management as well as current industry best practices and regulatory requirements.
• Required: Deep understanding of Proteomics/Protein mass spectrometry for PK and biomarker analysis
• Required: Demonstrated ability to work collaboratively with cross-functional teams to achieve shared goals.
• Required: Excellent organizational, analytical, and problem-solving skills.
• Required: Proven ability to manage multiple projects simultaneously and prioritize tasks in a fast-paced environment.
• Preferred: Experience with the Biophysical Characterization of Biologics (LCMS, SDS-PAGE, cIEF, SPR, BLI, SEC-HPLC, SEC-MALS, UV-VIS)
• Preferred: Experience working in a GLP environment (ELN/LIMS/automation)
• Preferred: Experience with HRMS and software for protein analysis/characterization

Skills

• LC-MS based protein quantification and proteomics
• Reagent management and CoA documentation
• Database management for reagents (reference standards, specifications, usage, expiration)
• Vendor management
• Regulatory compliance and training program development
• Risk assessment and cross-functional collaboration
• Industry trend monitoring and best-practice implementation

Education

• Ph.D. in chemistry, biochemistry, or biology with 3+ years of bioanalytical experience; M.S. with at least 7 years of bioanalytical experience will also be considered