Lead Scientist

Syngene International; Bengaluru; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Syngene International in Bengaluru (Bangalore) is seeking a Lead Scientist - Analytical Chemistry with expertise in Extractables and Leachables studies using LCMS, GCMS and HRMS. The role requires strong data interpretation, method development, and regulatory knowledge to ensure compliance with GMP and EHSS practices.

You will lead analytical projects, develop and validate methods, review technical reports, and train team members in CGMP environments.

Qualifications

• Hands-on LCMS, GCMS, HRMS experience in Extractables/Leachables studies.
• Knowledge of CGMP, ICH, USP and data integrity.
• Ability to prepare and review SOPs, reports and validation protocols.

Responsibilities

• Perform method development, method validation and transfer.
• Carry out Extractables and Leachables studies using LCMS/GCMS/HRMS.
• Prepare test procedures, development reports and technical validation documents.
• Ensure instruments are calibrated, qualified and compliant with 21 CFR Part 11 where applicable.
• Provide training and maintain documentation as per GMP and EHSS practices.

Skills

LCMS

GCMS

HRMS

Chromatography

Spectroscopy

ALCOA+

Documentation

MS-Office

Education

M.Pharm

M.Tech

M.Sc. (Analytical chemistry)

Tools

LCMS

GCMS

HRMS

Job description

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Job Role : Lead Scientist - Analytical Chemistry – E&L
Department : Analytical - BGRC
Job Location : Bangalore
About Syngene :
Syngene ( www.syngeneintl.com ) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply.
At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following 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 and compliance to company’s 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.

Core Purpose of the Role:

This role involves method development, method validation, method transfer by using laboratory instruments like LCMS /GCMS/ HRMS. Carry out specialized testing such as Extractables and Leachables studies.

Role Accountabilities:

• 08-12 Years of experience in Extractables/Leachables screening studies using LCMS/MS, GCMS & LC-HRMS.
• Data interpretation & identification of unknown Extractable/Leachable using LC-HRMS and preferably software’s like X Caliber, Chromeleon and CompoundDiscoverer.
• 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.

Behavioural Skills

Good Interpersonal skills
Self-time management
Good team player
Good communication skills

Syngene Values

All employees will consistently demonstrate alignment with our core values

• Excellence
• Integrity
• Professionalism

Experience

Candidate must have strong experience working in an analytical laboratory.

Skills and Capabilities

• Hands-on LCMS, GC MS, HRMS & other analytical instruments
• Theoretical knowledge in Chromatography and spectroscopy technique
• Good documentation/laboratory practices such as ALCOA+.
• Able to follow work instructions and perform the tasks under the supervision of the Team leader
• Preparation and Maintenance of all the documents
• Good knowledge of MS-office (word, excel, ppt).

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 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 individuals with disabilities.