Job Role : Principal Scientist - Analytical Chemistry 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.
Core Purpose of the Role:
This role involves method development, method validation, method transfer and R&D stability studies byusing laboratory instruments like LCMS, Gas Chromatography (GC). Carry out specialized testing, including Nitrosamines analysis, Extractables and Leachables studies.
Role Accountabilities:
To perform method development and validation studies using LCMS or GCMS techniques.
Extractables, Leachables, Nitrosamines studies using LCMS or GCMS.
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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 & 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 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.
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