Title: Study Personnel

Date: 3 Dec 2024

Job Location: Bangalore

Pay Grade

Year of Experience:

Designation: Study Personnel

Job Location: Bangalore

Department: GLP-Physical Chemical Testing

About Syngene

Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene’ s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market and lower the cost of innovation.

Job Purpose

To support characterization, analytical method development, validation, and dose formulation analysis.

The role will involve conducting all work in compliance with applicable regulatory requirements and Good Laboratory Practice.

Key Responsibilities

• Assist in the conduct of the study in compliance with the Principles of Good Laboratory Practice.
• Operating analytical equipment and ancillary equipment
• Compliance with the study plan and Standard Operating Procedures applicable to their involvement in the study.
• Recording of data with compliance to ALCOA+ principles
• Documenting and communicating and deviation to supervisor/team lead/study director
• Ensuring health and safety practices at the workplace
• Communicate with Management, QAU, Document Controller, TICO, and Archivist as per the Study Director's instructions.
• Verify the calibration and maintenance of the instrument/equipment before the start of the experiment.
  
  

Educational Qualification

• M.Sc./ M. Pharm in Chemistry
  
  

Technical/Functional Skills

• Experience/awareness of analytical and bioanalytical studies.
• Knowledge of different extraction techniques.
• Ability to handle analytical and ancillary instruments viz GC, UPLC/HPLC, LCMS, Solo VPE, pH meter.
• Review of calibration and maintenance records
• Calibration and use of micropipettes
• Using MS office, especially Microsoft Excel
• Documentation logbooks and raw data for activities performed without any errors.
• Knowledge of regulatory requirements, practices, and guidelines like OECD, USFDA, EMEA, ICH etc.
  
  

Experience

• 3-6 years in the relevant regulated environment
  
  

Behavioral Skills

• Good communication skill, both verbal and written
• High level of dedication, enthusiasm, motivation, and persuasive ability in a team and cross-functional environment.
• Ability to work successfully in a dynamic, ambiguous environment.
• Ability to meet tight deadlines and prioritize workloads.
• Ability to develop new ideas and creative solutions.
  
  

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.