Bioassay Specialist

Roles & Responsibilities

About the Job:

We are seeking highly motivated and innovative Bioassay Research Specialists who are passionate about biologic drug development to join us in our fast-growing R&D Lab. The Research Specialist will work both independently and with Research Scientists to provide timely, high-quality support of multiple therapeutic projects.

ROLES, RESPONSIBILITIES & EXPECTATIONS

• Design, develop and validate cell-based and non-cell-based bioassays and bioanalytical ligand binding assays for various biologics in compliance with different regulatory guidelines (FDA, EMA etc) and also in accordance with OECD-GLP principles.
• Conduct characterization studies for biosimilars and novel biologics
• Conduct ligand binding assays for clinical trial samples
• Prepare study plan, study data for the run and analyze data upon experiment completion and submit results for review
• Adhere to the laboratory work-flow and practices as per the QMS
• Draft SOPs, study protocols and study reports
• Perform literature review for various drug pipelines and assays as required
• Meet project milestones & deliverables with set quality
• Data compilation of multiple assays and assist Team Lead/Scientist/Project management team in dossier writing.
• · Ensure scientific integrity of studies conducted and reports submitted

REQUIREMENTS AND QUALIFICATIONS

• BSc or MSc in biomedical science, life science or equivalent
• Prior research and development experience are required
• Proficient in mammalian cell culture and aseptic techniques is a must
• Experience in ligand binding assays mainly ELISA, cell-based assays and reporter assays is highly desirable
• Good knowledge of cell based (potency) or ligand binding assays required in drug development process
• Proficient with office software (MS office, Teams), and familiar with statistical tools (Graphpad Prism, XLSTAT or PLA)
• Knowledge of bioassays, clinical bioanalytical method validations, GLP and ISO17025 is a plus
• Good written and verbal communication skills
• Superior problem solving and troubleshooting skills, attention to details
• Good interpersonal skills

Tell employers what skills you have

XLSTAT
Drug Development
Cell
Troubleshooting
Pipelines
ELISA
Problem Solving
Cell Culture
Research and Development
MS Office
Characterization
Attention to Details
Office Software
Laboratory
GLP

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