Job Title: Scientist
Job Location: Bangalore
About Syngene:
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 development of procedures, practices and systems that ensures safe operations and compliance to companys 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
Job Purpose:
Key Responsibilities:
- Ensure activities conducted in the bioanalytical lab are in compliance with established SOPs, procedures, systems, regulatory guidance without deviating from established procedures.
- Regular interaction and participation with Study director, Quality Control (QC) and Quality Assurance (QA) during raw data and reports review, closure of observations and archival.
- Will be involved in strategic planning for project execution, documentation of data, data analysis and interpretation of the results
- Ensure to complete the assigned tasks in timely manner.
Actively involved in discussion of SOPs, protocols, method and reports - Prepare reagents, buffers and maintain log book for assigned assays
Interpret results – anticipate and understand the issues related to the assay. - Participate in, and present data for discussions.
Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety. - Attend training on environment, health, and safety (EHS) measures imparted company
Educational Qualification:
Master’s degree in Biological Sciences (Preferably Biochemistry background) or a related field.
Technical/functional Skills:
- Background in immunoassay and bioanalytical Pharmacokinetics and Immunogenicity Assays with a good understanding as per regulatory guidance/ industry practices/internal Standard Operating Protocols is highly preferable.
- Should have hands-on experience in Ligand Binding Assay (LBA) development, validation and Sample analysis. Knowledge of ELISA and MSD assays are highly desirable.
- Knowledge and experience with regulatory requirements e.g. Organization for Economic Co-operation and Development (OECD), GXP, 21 CFR Part 11, European Medicines Agency (EMA) and Food and Drug Administration (FDA) guidelines.
Experience:
0-3 years of total experience in Pharmacokinetics and Immunogenicity Assays
Behavioral Skills
Should be independent
Excellent communication skills - written and oral in EnglishShould have good interpersonal skillsFlexibility and ability to work under strong time pressure
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 individual
