Latest MSc Biochemistry Job
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. Latest MSc Biochemistry Job details are provided below. Please go through the same and apply if you are interested.
Designation: Associate Scientist – Pharmacokinetics and Immunogenicity Assays
Job Location: Bangalore
Department: Clinical Development
Job Purpose: The position holder is responsible for performing bioanalysis which includes performing ligand binding assays related to Pharmacokinetics and Immunogenicity.
Key Responsibilities for Latest MSc Biochemistry Job:
• 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, interpretation and presentation of the results
• Ensure to complete the assigned tasks in timely manner.
• Actively involved in preparation of SOPs, protocols, method and reports
• Prepare reagents, buffers and maintain log book for
• 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 for Latest MSc Biochemistry Job:
• 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.
• Manuscript writing ability is preferable
• Proficiency in software like Laboratory Information Management System (LIMS), GraphPad, Adobe etc.
Experience:
• 6-9 years of experience in immunoassay laboratory. (CRO experience is preferable).
Behavioral Skills:
• Ability to work independently as well as with team members
• A strong proactive and independent thinker
• 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
Greetings, dear friends! We have prepared a set of interview questions and corresponding answers to help you prepare effectively for your upcoming interview. We encourage you to review these materials thoroughly in order to excel during your interview.
Can you describe your experience with regulatory compliance in bioanalytical labs, especially in relation to OECD, GXP, and FDA guidelines?
Answer: In my previous roles, I’ve consistently adhered to regulatory guidelines and standards, including OECD, GXP, and FDA regulations. I’ve been responsible for ensuring that all lab activities are conducted in strict compliance with these guidelines, from sample analysis to documentation and reporting. I believe my experience in maintaining regulatory compliance will be a valuable asset in this role.
Could you provide an example of a complex Pharmacokinetics or Immunogenicity Assay project you’ve worked on? How did you approach it and what were the outcomes?
Answer: Certainly. In a recent project, I was tasked with developing and validating a Ligand Binding Assay (LBA) for a novel therapeutic candidate. I started by thoroughly reviewing the project requirements and regulatory expectations. I then developed a detailed project plan, including timelines and milestones. Through meticulous planning and execution, we successfully validated the assay, achieving excellent sensitivity and specificity. This assay later played a critical role in the candidate’s clinical development, showcasing the importance of our work.
How do you stay up-to-date with the latest advancements and best practices in bioanalytical pharmacokinetics and immunogenicity assays?
Answer: Staying current in this field is crucial. I regularly attend conferences, webinars, and workshops related to bioanalysis. Additionally, I am an active member of professional organizations, allowing me to access the latest research, regulatory updates, and industry trends. This continuous learning keeps me informed about advancements and ensures that I implement best practices in my work.
Can you describe a situation where you had to handle a complex data analysis challenge in the lab? How did you approach it, and what was the result?
Answer: In a challenging data analysis scenario, I encountered unexpected variability in assay results. To address this, I conducted a thorough investigation, reviewing every step of the assay process and rechecking all equipment. Eventually, I identified a minor issue with a reagent storage condition that was affecting our results. After rectifying this, our data became consistent and reliable. This experience taught me the importance of meticulous troubleshooting and the value of persistence in problem-solving.
How do you manage your workload and prioritize tasks when working on multiple projects simultaneously, especially in a high-pressure environment?
Answer: Time management and prioritization are key skills in this role. I maintain a detailed project schedule, identifying critical deadlines and milestones. I also communicate regularly with team members and stakeholders to ensure alignment and manage expectations. When faced with multiple projects, I assess their urgency and impact, focusing on the ones with the highest priority. This approach has allowed me to successfully juggle multiple projects without compromising on quality or timelines.
Editor’s Note: Syngene Scientist Opening – MSc Biological Science & Biochem Apply Online. Please ensure you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of the latest industry news. Follow us on social media like Twitter, Telegram, Facebook
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