Bioanalytical Scientist

Position Overview

ScienceCast is seeking an experienced Bioanalytical Scientist to join our team in Fall River, MA. The successful candidate will be responsible for developing, optimizing, and validating immunoassays, including ELISA and MSD techniques, under both non-GLP and GLP conditions to support Celldex's pipeline projects.

Key Responsibilities

• Develop, refine, and validate diverse immunoassays compliant with GLP and non-GLP standards.
• Collaborate seamlessly with laboratory scientists, management, and Quality Assurance teams to ensure timely production of nonclinical and clinical data.
• Perform data review, assist in data transfer preparations, and contribute to report generation.
• Coordinate with Quality Assurance to plan and execute lab, data, and report audit activities.
• Author, update, and critically assess method-specific SOPs to maintain regulatory compliance.
• Engage in data analysis and perform general laboratory research tasks.

Candidate Qualifications

• Possess a BS, BA, MS, or PhD degree in life sciences.
• Bring 2 to 8 years of industry experience within biotechnology, ideally in assay development within regulated environments.
• Demonstrate expertise in immunoassay development, with hands-on experience in designing, optimizing, and validating PK, ADA, and IHC assays utilizing animal or human samples.
• Understand and apply regulatory guidelines, preferably GLP, to experimental design and planning.
• Have prior experience working under GLP and performing assay validations.
• Skilled in drafting and reviewing analytical SOPs, study protocols, and comprehensive reports.
• Exhibit excellent communication and organizational capabilities, able to work autonomously and collaboratively within a team setting.

Additional Information

Applicants are encouraged to submit a ScienceCast portfolio demonstrating their research work alongside their application.