Syngene International Ltd is an integrated research, development and manufacturing services company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical sectors. Syngene’s 4500+ scientists offer both skills and the capacity to deliver great science, robust data management and IP security and quality manufacturing, at speed, to improve time-to-market and lower the cost of innovation. With a combination of dedicated research facilities for Amgen, Baxter, Bristol-Myers Squibb, and Herbalife, as well as 1.9 Mn sq ft of specialist discovery, development and manufacturing facilities, Syngene works with biotech companies pursuing leading edge science as well as multinationals including GSK and Merck KGaA.
Post : Senior Executive (52980)
Job Description
Core Purpose of the Role : This role involves method development, method validation, method transfer and R&D stability studies by using laboratory instruments like Ultra performance liquid chromatography (UPLC), High Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Ultraviolet (UV) spectrophotometer, Polarimeter, etc.
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
Role Accountabilities
1. Analytical method transfer, method development, Validation and Compendia method assessment and optimization.
2. Drafting of analytical method validation /verification/ transfer protocols/ reports/stability protocols.
3. Should have the hands-on experience on HPLC, UPLC, GC-HS, Ion chromatography and Tirado; UPLC-QdA; Size exclusion chromatography and UPC2
4. Knowledge on Empower3 and Tiamo software.
5. Regular stability testing in lab. MT and MV lab work.
6. Very well knowledge on ICH Q2 R1 and USP guidelines <1224, 1225 and 1226>.
7. Stability studies overview and must worked in GMP environment.
8. Must have hands on experience on LIMS, Trackwise and EDMS.
Candidate Profile
1. Experience – 3 to 6 years
2. Education – Msc – Analytical chemistry/ Mpharm
Additional Information
Experience : 3 to 6 years
Qualification : M.Sc, M.Pharm
Location : Bangalore
Industry Type : Pharma / Healthcare/ Clinical research
End Date : 31st December, 2022
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