Senior Scientist- BAL-II

Syngene International; Bengaluru; On-site; INR 1,200,000 - 2,400,000; Full time

Job summary

Syngene International is seeking a bioanalytical scientist to perform ligand binding assays related to pharmacokinetics and immunogenicity. The role involves developing, validating, and analyzing LBA methods with ELISA and MSD, while ensuring compliance with OECD, GXP and FDA/EMA guidelines.

The candidate should have a Master’s in Biological Sciences with 5–8 years of experience in PK and immunogenicity assays, and strong English communication skills for cross‑functional collaboration.

Qualifications

• Master’s degree in Biological Sciences (Biochemistry preferred).
• 5–8 years in PK and Immunogenicity assays.
• Hands‑on LBA development and validation experience.
• Experience with ELISA and MSD assays.
• Knowledge of OECD, GXP, 21 CFR 11, EMA and FDA guidelines.
• Excellent English communication.

Responsibilities

• Ensure bioanalytical lab activities comply with SOPs and regulatory guidance.
• Interact with study director, QC and QA during data review and archival.
• Contribute to project planning, data documentation, and interpretation of results.
• Complete assigned tasks in a timely manner.
• Participate in SOPs, protocols, methods and reports discussions.
• Prepare reagents, buffers, and maintain assay log books.
• Interpret results and address assay issues.
• Present data for discussions.
• Follow EHS requirements at all times.
• Attend EHS training.

Skills

LBA development

Immunoassay

ELISA/MSD

Pharmacokinetics

Regulatory knowledge

Data interpretation

English communication

Independence

Education

Master's in Biological Sciences

Job description

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Job Purpose: The position holder is responsible for performing bioanalysis which includes performing ligand binding assays related to Pharmacokinetics and Immunogenicity.

Key Responsibilities:

• Ensure activities conducted in the bioanalytical lab are in compliance with established SOPs, procedures, systems, regulatory guidance without deviating from established procedures.
• Regular interaction and participation with Study director, Quality Control (QC) and Quality Assurance (QA) during raw data and reports review, closure of observations and archival.
• Will be involved in strategic planning for project execution, documentation of data, data analysis and interpretation of the results
• Ensure to complete the assigned tasks in timely manner.
• Actively involved in discussion of SOPs, protocols, method and reports
• Prepare reagents, buffers and maintain log book for assigned assays
• Interpret results – anticipate and understand the issues related to the assay.
• Participate in, and present data for discussions.
• Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety.
• Attend training on environment, health and safety (EHS) measures imparted company

Educational Qualification:

• Master’s degree in Biological Sciences (Preferably Biochemistry background) or a related field.

Technical/functional Skills:

• Background in immunoassay and bioanalytical Pharmacokinetics and Immunogenicity Assays with a good understanding as per regulatory guidance/ industry practices/internal Standard Operating Protocols is highly preferable.
• Should have hands‑on experience in Ligand Binding Assay (LBA) development, validation and Sample analysis. Knowledge of ELISA and MSD assays are highly desirable.
• Knowledge and experience with regulatory requirements e.g. Organization for Economic Co-operation and Development (OECD), GXP, 21 CFR Part 11, European Medicines Agency (EMA) and Food and Drug Administration (FDA) guidelines.

Experience:

• 5-8 years of total experience in Pharmacokinetics and Immunogenicity Assays

Behavioral Skills:

• Should be independent
• Excellent communication skills - written and oral in English
• Should have good interpersonal skills
• Flexibility and ability to work under strong time pressure