Syngene is inviting applications for the role of Senior Scientist – Analytical at its Bangalore location. This opportunity is for candidates with an analytical background and experience in Extractables/Leachables screening studies using LCMS/MS, GCMS and LC-HRMS.

The role is part of the Analytical – BGRC department and involves analytical method work, instrument compliance, documentation, investigations and adherence to GMP, data integrity and EHSS practices.

Job Details

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.

Key Responsibilities

• 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.
• Carry out investigations in case of deviations, OOT, OOC & OOS.
• 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.

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 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.

Experience

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

Qualification

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

Syngene Values

All employees will consistently demonstrate alignment with Syngene core values:

• Excellence
• Integrity
• Professionalism

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.

How to Apply

Interested candidates can review the official job details and apply online through the official Syngene careers page.

Candidates should verify all details on the official application page before applying.

Author: PharmaBharat Editorial Team