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Promea Trainee Job For BSc & MSc Biotech, Biochem Trainee/ Jr. Executive, Apply Online
Hey there, looking for assistance with possible interview questions and answers for the role of a Biologics Production – Trainee/ Jr. Executive at Promea? Then check them below
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Biologics Production – Trainee/ Jr. Executive
HYDERABAD
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0 YEARS
Job Summary:
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The Executive in the Biologics Production Department will play a crucial role in the manufacturing and production of biologic drugs in Promea. They will be responsible for ensuring the efficient and compliant production of biologics, adhering to quality standards, safety regulations, and production schedules.
Key Responsibilities:
- Execute and oversee the manufacturing operations of biologic drugs, including upstream and downstream processes, purification, and formulation.
- Ensure compliance with current Good Manufacturing Practices (cGMP) and standard operating procedures (SOPs) in all production activities.
- Prepare and review production documents, batch records, and production reports, ensuring accuracy, completeness, and compliance with regulatory requirements.
- Collaborate with cross-functional teams, including process development, quality control, and engineering, to optimize production processes and troubleshoot any technical issues.
- Monitor and analyze production data, yield trends, and key performance indicators (KPIs) to identify areas for improvement and implement corrective actions.
- Participate in technology transfer activities, including process scale-up, process validation, and equipment qualification.
- Support investigations of deviations, out-of-specification (OOS) results, and non-conformances, and assist in implementing appropriate corrective and preventive actions (CAPAs).
- Ensure proper documentation and maintenance of equipment, production areas, and production records in accordance with cGMP guidelines.
- Contribute to continuous improvement initiatives, suggesting process enhancements, efficiency improvements, and cost-saving measures.
- Stay updated on industry trends, regulatory requirements, and technological advancements in biologics production, and propose and implement relevant improvements.
Qualifications and Skills:
- Bachelor’s or Master’s degree in Biotechnology, Biochemistry, or a related field.
- Solid understanding of biologics production processes, including cell culture, fermentation, purification, and formulation.
- Familiarity with cGMP guidelines and regulatory requirements specific to biologics manufacturing.
- Experience with bioreactors, chromatography systems, filtration technologies, and other equipment used in biologics production.
- Knowledge of process optimization, scale-up, and technology transfer in biologics manufacturing.
- Strong analytical and problem-solving skills, with attention to detail and the ability to analyze complex data sets.
- Excellent organizational and time management abilities, with the capability to manage multiple priorities and meet production schedules.
- Effective communication and interpersonal skills, with the ability to collaborate and work effectively in cross-functional teams.
- Proficiency in using manufacturing execution systems (MES) and other production-related software.
- Flexibility to work in shifts, including weekends and holidays, as required in a biologics production environment.
Hey there, looking for assistance with possible interview questions and answers for the role of a Biologics Production – Trainee/ Jr. Executive at Promea? Then check them below
- Can you explain your understanding of current Good Manufacturing Practices (cGMP) and how you would ensure compliance with them in biologics production? Answer: cGMP is a set of quality standards and regulations that ensure the safety, efficacy, and quality of pharmaceutical products. In biologics production, I would adhere to cGMP guidelines by implementing standard operating procedures, conducting regular audits, training staff on cGMP principles, and maintaining proper documentation of all production activities.
- Describe your experience with bioreactors, chromatography systems, and filtration technologies in the context of biologics production. Answer: I have hands-on experience working with bioreactors, chromatography systems, and filtration technologies. I am familiar with their operation, maintenance, and troubleshooting. I have successfully used these equipment to execute upstream and downstream processes, ensuring efficient and high-quality biologic drug production.
- How would you approach process optimization, scale-up, and technology transfer in biologics manufacturing? Answer: Process optimization involves identifying areas for improvement, such as yield enhancement or cost reduction, and implementing changes to optimize the production process. Scale-up refers to the successful transition from laboratory-scale to large-scale production. Technology transfer involves transferring the production process from one site to another. I would approach these activities by thoroughly evaluating the process, conducting feasibility studies, collaborating with cross-functional teams, and ensuring seamless knowledge transfer.
- Give an example of a time when you faced a technical issue in biologics production and how you resolved it. Answer: In a previous project, we encountered a contamination issue during the cell culture stage. To resolve it, I initiated an investigation to identify the source of contamination, implemented stricter aseptic techniques, and performed environmental monitoring. I also revised the cleaning and disinfection procedures, and conducted additional training for the team. These measures successfully resolved the issue and ensured a clean and sterile production environment.
- How do you stay updated on industry trends, regulatory requirements, and technological advancements in biologics production? Answer: I believe in continuous learning and staying informed about the latest developments in the field. I regularly attend industry conferences, seminars, and workshops. I also follow reputable scientific journals, publications, and online forums to stay updated on new regulations, technologies, and best practices in biologics production. Additionally, I actively participate in professional networks and engage in knowledge-sharing activities with colleagues in the industry.