About the Job:
We are seeking highly motivated and innovative Bioassay Research Specialists/Scientists who are passionate about biologic drug development to join us in our fast-growing R&D Lab. The applicant for Scientist should demonstrate competency in designing and developing assays and leading independent projects. The Research Specialist will work both independently and with Research Scientists to provide timely, high-quality support of multiple therapeutic projects.
ROLES, RESPONSIBILITIES & EXPECTATIONS
· Develop and validate cell-based and ligand binding assays in compliance with FDA/EMA and GLP guidelines
· Test biologicals for potency in validated assays.
· Perform new method validations or refine current methods in response to changing requirements of drug development, and under the direction of Team leader.
· Gather data and perform statistical analysis.
· Interpret and communicate findings.
· Document work, results, analyses, and findings in laboratory notebooks or study folders as appropriate.
· Draft or review SOPs and reports
· Provide technical and scientific expertise to enable proper operation and maintenance of equipment as required.
· Follow company SOPs and assist in their revision as required.
· Perform other tasks as assigned by supervisor.
REQUIREMENTS AND QUALIFICATIONS
· Scientist: PhD in biomedical science, life science or equivalent
Research Specialist: BSc or MSc in biomedical science, life science or equivalent with at least one year of laboratory-based experience in the biotechnology and/or pharmaceutical industry.
· Proficiency in mammalian cell culture and aseptic techniques is a must.
· Experience in cell-based assays, SDS-PAGE, Western Blot, flow cytometry, immunostaining and microscopy techniques is highly desirable.
· Familiar with ligand binding assays such as ELISA and BLI
· Experience in drafting of SOPs, protocols and reports
· Proficiency with office management software (MS office, Teams), and statistical tools (Prism, SPSS, or PLA).
· Knowledge in method validation, GLP and ISO17025 is a plus
· Ability to deliver quality data on time to meet project timelines.
· Outstanding organizational, interpersonal, and oral communication skills are critical.
· Superior attention to detail, problem solving and troubleshooting skills are desirable.
