Lead Scientist - Analytical

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

Job summary

Syngene is seeking a Lead Scientist - Analytical to lead advanced LC-MS based studies, extractables and leachables screening, and data interpretation in a GMP environment at its Bangalore facility.

You will develop procedures, validate methods, and ensure regulatory compliance with CGMP, ICH, USP. Strong instrument troubleshooting and training capabilities are expected.

Qualifications

• Foundational experience in analytical chemistry.
• Experience in Extractables/Leachables screening using LCMS/MS, GCMS and LC-HRMS.
• Knowledge of CGMP, ICH, USP and other regulatory requirements.

Responsibilities

• Lead responsibilities in LC-HRMS based extractables/leachables studies.
• Prepare test procedures, development reports, and validation protocols.
• Qualify, calibrate, and troubleshoot analytical instruments.
• Investigate deviations, OOT, OOC, and OOS.
• Ensure compliance with 21 CFR Part 11 where applicable.
• Prepare and review SOPs, IOPs, and EOPs; provide training when required.
• Comply with GMP, data integrity and EHSS practices.

Skills

Analytical mindset

Data interpretation

Regulatory compliance awareness

Laboratory safety awareness

Education

M. Pharm/ M. Tech/ M.Sc. (Analytical Chemistry/Chemistry)

Tools

LCMS/MS

GCMS

LC-HRMS

Job description

About Syngene

Syngene (www.syngeneintl.com) is an innovation-led contract research, developmentand manufacturing organization offering integrated scientific services from early discovery to commercialsupply.

Date: 28 Jul 2026

Location:
Bangalore, KA, IN, 560099

Division: Dedicated Centre

Job Role :

Lead Scientist - Analytical

Department :

Analytical - BGRC

Job Location :

Bangalore

About Syngene

Syngene (www.syngeneintl.com) is an innovation-led contract research, developmentand manufacturing organization offering integrated scientific services from early discovery to commercialsupply.

At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placedsafety at par with business performance with shared responsibility and accountability, includingfollowing safety guidelines, procedures and SOPs, in letter and spirit.

Mandatory expectation for all roles as per Syngene safety guidelines:

• 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 andcompliance to company’s integrity & quality standards
• Driving a corporate culture that promotes environment, health, and safety (EHS) mindset andoperational 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 arecompleted 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.

Role Accountabilities For LC-HRMS Position

• Candidate must have experience in Extractables/Leachables screening studies using LCMS/MS, GCMS & LC-HRMS.
• Data interpretation & identification of unknown Extractable/Leachable using LC-HRMS
• Responsible for preparation of test procedures, development reports, technical reports, validation protocols and reports.
• Abilities in qualification, calibration and troubleshooting of analytical instruments.
• To carry out the investigations in case of deviations, OOT, OOC & OOS.
• To ensure instruments are compliant to 21 CFR Part 11 requirements, wherever applicable.
• Preparation & review of SOPs, IOPs and EOPs and provide training whenever required.
• Must have applicable knowledge in CGMP, ICH, USP and other regulatory requirements.
• Must comply with GMP, data integrity & EHSS practices.

Syngene Values

All employees will consistently demonstrate alignment with our core values

• Excellence
• Integrity
• Professionalism

Experience

Foundational experience in an analytical background, experience in Extractables/Leachables screening studies using LCMS/MS, GCMS & LC-HRMS.

Education

M. Pharm/ M. Tech/ M.Sc. (Analytical chemistry/Chemistry)

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 mentaldisability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, geneticinformation, marital status, status with regard to public assistance, veteran status, or any othercharacteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonableaccommodations for qualified individuals with disabilities.