Analytical Chemistry Analyst at 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 the development of procedures, practices, and systems that ensure safe operations and compliance to the 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, 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.
- Must have strong hands-on experience in development and validation of Assay & related substances methods for drug substance/drug product.
- Must have experience in handling HPLC, UPLC (Empower-3 software), GC, UV Visible spectrophotometer balances, Potentiometer, and stability chambers
- Shall have experience on Good documentation/laboratory practices such as ALCOA+
- Experience in calibration and qualification of HPLC, UPLC, GC, and other QC laboratory instruments
- Shall prepare and review the raw data sheets, instrument operating procedures, and standard operating procedures
- Shall have good experience in handling QMS (such as incidents, Out of Specifications, Deviations, and Change control)
- Shall be responsible for procurement and inventory maintenance of Pharmacopeial Standards/Chemicals/Reagents/Consumables/Spares etc., required for the projects
- Shall adhere to the procedure of GxP/Safety and as per the procedure defined in the internal standard operation procedure
- Shall operate the MS office (word, excel, ppt), outlook, and other essential tools required for routine activity
- Good communication and e-mail writing skills are required since the candidate needs to communicate to clients/external users situated overseas
- Good Interpersonal skills
- Self-time management
- Good Team player
- Polite/Good Communication skills
All employees will consistently demonstrate alignment with our core values:
Specific requirements for this role
Experience: 3-6 years
Skills and Capabilities:
- Hands-on HPLC, UPLC/UHPLC, CG, UV-Visible spectrophotometer, Potentiometer, and QC 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. / B.Sc. (Analytical chemistry/Chemistry) with 3-6 years
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