Syngene MSc Biochemistry Job opening. Apply Now!
Syngene, a leading research and development organization in life sciences, is currently offering an exciting opportunity for a Senior Research Associate in Biochemistry. This MSc-level position promises a dynamic environment for talented professionals to contribute to cutting-edge research and innovation. Interested candidates can apply online to join Syngene’s dedicated team in advancing scientific discovery.
Designation: Senior Research Associate – Pharmacokinetics and Immunogenicity Assays (54827)
Company: Syngene
Job Location: Bangalore
Department: Immunogenicity Research Laboratory
Job Purpose: The position holder is responsible for performing bioanalysis which includes performing ligand binding assays related to Pharmacokinetics and Immunogenicity.
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.
• Ensure to complete the assigned tasks in timely manner.
• 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
• Attend training on environment, health, and safety (EHS) measures imparted company
Syngene MSc Biochemistry Job- Required Educational Qualification:
• Master’s degree in Biological Sciences (Preferably Biochemistry background) or a related field.
Syngene MSc Biochemistry Job- Required Technical/functional Skills:
• Should have a strong background in immunoassay and bioanalytical Pharmacokinetics and Immunogenicity Assays with a good understanding as per regulatory guidance/ industry practices/internal Standard Operating Protocols.
• 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:
• 3-6 years of total experience in Pharmacokinetics and Immunogenicity Assays
Behavioral Skills:
• Should be independent.
• Excellent communication skills – written and oral in English
• Should have good interpersonal skills
• Large degree of flexibility and ability to work under strong time pressure
Syngene MSc Biochemistry Job. The possible interview Q & A to help you with:
1. Can you explain your experience with ligand binding assays and their importance in bioanalysis?
Answer: Ligand binding assays are critical in bioanalysis as they help assess the pharmacokinetics and immunogenicity of drug compounds. I have extensive hands-on experience in developing, validating, and analyzing ligand binding assays (LBAs), which are essential for determining drug concentration and immunogenic response in biological samples. This includes expertise in ELISA and MSD assays, which are widely used in this context.
2. How do you ensure compliance with regulatory requirements and internal SOPs when conducting bioanalytical work?
Answer: Ensuring compliance with regulatory requirements and internal SOPs is paramount in bioanalytical work. I consistently adhere to established SOPs and regulatory guidelines, such as those from OECD, GXP, 21 CFR Part 11, EMA, and FDA. This includes meticulous documentation, adherence to sample handling protocols, and maintaining the integrity of data throughout the process.
3.Can you provide an example of a complex bioanalytical problem you’ve encountered and how you successfully resolved it?
Answer: In a previous role, we encountered a challenge in achieving assay sensitivity for a critical bioanalysis project. After troubleshooting and optimizing assay conditions, we successfully improved sensitivity by modifying the reagent composition and assay parameters. This experience highlights my problem-solving skills and commitment to delivering reliable results.
4.Describe your approach to maintaining a safe and compliant work environment, particularly regarding EHS (Environment, Health, and Safety) measures.
Answer: Safety is a top priority in bioanalytical work. I strictly follow EHS measures, including wearing appropriate personal protective equipment, handling hazardous materials with care, and participating in regular EHS training. I also encourage a safety-conscious culture among team members, ensuring a safe working environment for all.
5.How do you stay updated on the latest advancements and best practices in bioanalytical Pharmacokinetics and Immunogenicity Assays?
Answer: Staying current in this field is crucial. I regularly attend relevant conferences, workshops, and webinars to learn about the latest advancements and regulatory updates. Additionally, I am an active member of professional organizations and subscribe to scientific journals to access the most recent research and best practices, allowing me to continually enhance my knowledge and skills in bioanalysis.