Senior Executive

Syngene International Limited; Bengaluru; On-site; INR 600,000 - 1,000,000; Full time

Job summary

Syngene International Limited seeks a hands-on analytical scientist to develop, validate and transfer assay methods for drug substances/products. Proficiency in HPLC/UPLC, GC and UV-Vis spectroscopy is required, with strong documentation practices.

Experience with ALCOA+ and QMS processes, plus instrument calibration and data review, will be essential for ensuring compliance and high-quality results in a fast-paced lab environment in Bengaluru.

Qualifications

• Must have strong hands-on experience in development and validation of Assay & related substances methods for drug substance/drug product.
• Experience in handling HPLC, UPLC (Empower-3 software), GC, UV Visible spectrophotometer balances, Potentiometer, and stability chambers.
• Shall have good documentation/LABORATORY practices such as ALCOA+.
• Experience in calibration and qualification of various analytical instruments HPLC, UPLC, GC, and other QC laboratory instruments.

Responsibilities

• Shall prepare and review the raw data sheets, instrument operating procedures, and standard operating procedures.
• Shall have good experience in handling of 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 as per internal SOPs.

Education

M. Pharm/ M. Tech/ M.Sc. / B.Tech., B.Sc. (Analytical chemistry/Chemistry)

Tools

HPLC

UPLC/UHPLC

GC

UV-Vis spectrophotometer

Potentiometer

Particulate matter analysis

Empower-3

Job description

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.

Mandatory expectation for all roles as per Syngene safety guidelines

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.

• 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, methodvalidation, methodtransfer 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, Particulate matter analysis using Malvern, PAMAS, HIAC and other relevant instrumentation techniques. etc.

Role Accountabilities:

• 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, Particulate matter analysis techniques.
• Shall have experience on Good documentation/laboratory practices such as ALCOA+.
• Experience in calibration and qualification of various analytical instruments 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 of 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
• Must possess good communication and e-mail etiquettes.

Behavioural Skills

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

All employees will consistently demonstrate alignment with our core values

Specific requirements for this role

Experience

2-6 years

Skills and Capabilities:

• Hands-on HPLC, UPLC/UHPLC, CG, UV-visible spectrophotometer, Potentiometer, Particulate matter analysis techniques 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.Tech., B.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.