Scientist

Syngene; Bengaluru; On-site; INR 600,000 - 1,200,000; Full time

Job summary

Syngene in Bangalore seeks a Scientist to perform bioanalysis focused on pharmacokinetics and immunogenicity, including ligand binding assay work and data interpretation. The role requires a master’s degree in biological sciences and hands-on assay experience.

You will work under regulatory guidance, ensure SOP compliance, collaborate with QA/QC, and contribute to project planning and data reporting while maintaining EHS standards and safety practices.

Qualifications

• Master’s degree in Biological Sciences (Preferably Biochemistry background) or a related field.
• Hands-on experience in Ligand Binding Assay (LBA) development, validation and Sample analysis.
• Knowledge of ELISA and MSD assays desirable.
• Knowledge of regulatory requirements (OECD, GXP, 21 CFR Part 11, EMA, FDA).

Responsibilities

• Ensure bioanalytical lab activities comply with SOPs and regulatory guidance.
• Interact with Study Director, QC and QA during data review and archival.
• Participate in project execution planning, data documentation and interpretation.
• Complete assigned tasks promptly and contribute to SOP/protocol discussions.
• Prepare reagents, buffers and maintain logs for assays; interpret results.
• Present data for discussions and follow EHS requirements at all times.
• Attend EHS training imparted by the company.

Skills

Immunoassay

Bioanalysis

Pharmacokinetics

Immunogenicity

Ligand Binding Assay

Education

Master's degree in Biological Sciences

Tools

ELISA

MSD assays

Job description

Job Title: Scientist

Job Location: Bangalore

About Syngene

Syngene (www.syngeneintl.com) is an innovation-led contract research, development and manufacturing organization offering integrated scientificservices from early discovery to commercial supply.

Safety Expectations

• Overall adherence to safe practices and procedures of oneself and the teams aligned
• Contributing to development of procedures, practices and systems that ensures safe operations and compliance to companys integrity & quality standards
• Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times.
• Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace.
• Ensure all assigned mandatory trainings related to data integrity,health, and safety measures are completed on time by all members of the team including self
• Compliance to Syngene s quality standards at all times
• Hold self and their teams accountable for the achievement of safety goals
• Govern and Review safety metrics from time to time

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

0-3 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

Equal Opportunity Employer

It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individual