Research Associate - Bio-immunoassay labs

Job Description

Role Objective: 

The primary objective is to do initial literature review and lab-scale experimentation to the successful technology transfer of qualified assays to the production plant.

KEY RESPONSIBILITIES

• Strategic Input: Conduct ongoing referencing and literature reviews to provide high-level strategic guidance at all project stages.

• Method Evaluation: Assess proposed methodologies by reviewing regulatory guidelines (FDA/EMA), pharmacopeia standards, and peer-reviewed research.

• Resource Identification: Determine and procure critical biological components, including initial cell lines and antibody requirements, based on the selected method.

• Assay Development: Execute hands-on lab experiments for the development and optimization of bio-assays and immuno-assays.

• Method Qualification: Conduct rigorous testing to ensure method reproducibility and reliability prior to scale-up.

• Technical Writing: Prepare and review comprehensive documentation, including:

  • Method Development Reports (MDR)

  • Method Qualification/Validation Protocols and Reports

  • Standard Analytical Procedures (SAP)

  • Method Transfer Protocols

• Knowledge Transfer: Demonstrate lab processes to plant operators within lab premises to ensure seamless adoption.

• Operational Support: Observe the initial implementation in the plant environment and act as the primary point of contact for resolving post-transfer technical queries.

STAKEHOLDER INTERACTION

Type of Interaction: Internal

Interaction with:  R&D Scientists, Plant Operators, Quality Assurance (QA)

Nature of Interaction:  Collaborative; providing technical training, troubleshooting transfer issues, and ensuring regulatory alignment..

Type of Interaction: Internal & External 

Interaction with: Vendors, Contract Research Organizations (CROs), Regulatory Agencies

Nature of Interaction:  Consultative; sourcing reagents (cell lines/antibodies) and staying updated on evolving global pharmacopeia standards..

JOB REQUIREMENTS

Professional Experience and Relevant Skills

• Experience: 7–12 years hands-on experience in Bio-assay or Immuno-assay development within a regulated pharmaceutical or biotech environment.

• Technical Skills:

• Proven experience in Bio-assay or Immuno-assay development within a regulated pharmaceutical or biotech environment.

• Deep familiarity with Pharmacopeia guidelines and global regulatory standards.

• Strong technical writing skills with experience in drafting SAPs and Validation protocols.

• Hands-on expertise in cell culture and antibody characterization.

• Excellent communication skills for training plant personnel and managing cross-functional technical queries.

Academic Qualifications & Certifications

• Educational Qualification: Master’s degree (M.Sc/ M.Tech) or Ph.D. in Biotechnology, Biochemistry, Molecular Biology, or a related life sciences field.

More Info

Education