Study Director - Immunogenicity Research Laboratory

Syngene International; Bengaluru; On-site; INR 4,200,000 - 5,600,000; Full time

Job summary

Syngene International in Bangalore is seeking a Study Director for Pharmacokinetics and Immunogenicity Assays to lead bioanalytical work within the Translational and Clinical Research division.

The role focuses on ligand binding assay development, validation and sample analysis, ensuring SOP/regulatory compliance, data interpretation, and timely presentation of results to study directors and QA teams. Advanced communication and manuscript-writing skills are desirable.

Qualifications

• 6–9 years of experience in immunoassay laboratories.
• CRO experience preferred.

Responsibilities

• Ensure activities in bioanalytical lab comply with SOPs and regulatory guidance.
• Interact with Study Director, QC and QA during data review and archival.
• Strategic planning for project execution, data documentation, analysis, interpretation and presentation of results.
• Complete assigned tasks in a timely manner.
• Prepare SOPs, protocols, methods and reports.
• Prepare reagents, buffers and maintain log books for assays.
• Interpret results and address assay-related issues.
• Present data for discussions with project teams.
• Follow EHS requirements and undergo EHS training.

Skills

Immunoassay and bioanalysis

LBA development & validation

ELISA & MSD assays

Regulatory awareness (OECD, GXP, 21 CR

Education

Master’s degree in Biological Sciences (Biochemistry preferred)

Tools

LIMS

GraphPad

Adobe

Job description

Study Director - Immunogenicity Research Laboratory

Location: Bangalore, KA, IN, 560100

Division: Discovery Services

Job Title:

Study Director - Pharmacokinetics and Immunogenicity Assays

Job Location:

Bangalore

Department:

Translational and Clinical Research

About Syngene

Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene’ s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve R& productivity, speed up time to market and lower the cost of innovation.

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, interpretation and presentation of the results
• Ensure to complete the assigned tasks in timely manner.
• Actively involved in preparation 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:

• Should have a strong background in immunoassay and bioanalytical Pharmacokinetics and Immunogenicity Assays with a good understanding as per regulatory guidance/ industry practices/internal Standard Operating Protocols.
• 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.
• Manuscript writing ability is preferable
• Proficiency in software like Laboratory Information Management System (LIMS), GraphPad, Adobe etc.

Experience:

• 6-9 years of experience in immunoassay laboratory. (CRO experience is preferable).

Behavioral Skills:

• Ability to work independently as well as with team members
• A strong proactive and independent thinker
• Excellent communication skills - written and oral in English
• Should have good interpersonal skills
• Large degree of 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 accommodation for qualified individuals with disabilities.