Bioassay Development Scientist

Job Description: Bioassay Development Scientist

Position Overview
We are seeking a skilled and motivated Bioassay Development Scientist to design, develop, and validate biological assays for biosimilars. The role involves working on proliferation assays, biomolecular interaction studies, and assay optimization to support upstream and downstream process development. The ideal candidate will oversee bioassay operations, ensure compliance with GLP and regulatory standards, and contribute to analytical development projects.

Key Responsibilities
Bioassay Development & Validation

• Design and develop biological assays for assigned biosimilars under the guidance of the Head of R&D.
• Develop and validate all kinds of cell based, ELISA, SPR assays for in-house as well as CDMO samples using various positive controls.
• Developing transient and stable clones using lipofection or electroporation methods for cell based assays development.
• Develop and optimize assays related to process impurities like HCP, HCD, PA leachates and endotoxin estimation assays.
• Conduct biomolecular interaction analysis using Octet or SPR System.
• Develop and optimize bioassays to support upstream and downstream process development.
• Utilize statistical tools such as PLA and GraphPad Prism for biological data analysis.

Operational & Team Leadership

• Oversee bioassay team operations, including experimental execution, data analysis, and report preparation.
• Participate in departmental meetings to discuss project execution and ensure timely completion.
• Train and mentor junior team members on bioassay techniques and best practices.

Documentation & Compliance

• Prepare, review, and maintain Standard Operating Procedures (SOPs) related to bioassays.
• Ensure compliance with bioassay safety, Good Laboratory Practices (GLP), and regulatory standards.
• Implement best practices for sanitation, hygiene, PPE usage, and pest control within lab facilities.
• Maintain accurate and complete documentation of all research and development activities.
• Review and approve specifications, Standard Testing Procedures (STPs), and General Test Procedures (GTPs).

Equipment & Quality Management

• Maintain and approve equipment/instrument master lists, preventive maintenance (PMP), and calibration schedules.
• Ensure timely review and approval of validation protocols, stability studies, and method development reports.
• Execute projects related to analytical development, identifying potential issues and implementing preventive measures.

Qualifications:

• Education
• Master's or Ph.D. degree in Biochemistry, Biotechnology, or related field.
• Experience:
• 10+ years in bioassay development, qualification, validation and tech transfer.
• Post-doctoral fellows having minimum 2 years of experience in bioassay development.

Preferred Experience:

• Experience in managing outsourced projects or working in a contract development and manufacturing environment.
• Familiarity with regulatory agencies expectations (FDA, EMA) for purification processes.