Executive

In Meril life sciences Pvt. Ltd. (Micro CRISPR) , particularly in biomanufacturing, upstream and downstream refer to the two main stages of producing biotechnology products, such as vaccines, proteins, and cell therapies. Job roles in these areas are distinct and require specialized skills.Upstream job descriptionUpstream bioprocessing focuses on the initial phases of production, including cell culture development, fermentation, and growth optimization. Professionals in these roles work with living cells to produce the desired biological product.General responsibilities- Cell culture and fermentation: Cultivate and grow microbial or mammalian cell lines in bioreactors under controlled conditions to maximize product yield. - Process development: Develop and optimize upstream processes, including selecting the right cell line and culture media, to ensure product quality and consistency. - Bioreactor operations: Set up, operate, and maintain laboratory-scale and pilot-scale bioreactors, and monitor key parameters such as temperature, pH, and dissolved oxygen. - Harvest and clarification: Collect and prepare the harvested material from the bioreactor for the downstream purification stage, which may involve filtration. - Experimentation: Conduct small-scale studies and experiments to support process development and technology transfer. - Documentation and compliance: Document all experimental data in electronic lab notebooks (ELNs) and ensure all processes adhere to regulatory and good manufacturing practice (GMP) guidelines.Key skills and qualifications- Education: A bachelor's or master's degree in biotechnology, or a related life science field. - Experience: Hands-on experience in mammalian or microbial cell culture systems atleast 2 years preferred - Technical skills: Strong knowledge of aseptic techniques, media preparation, and process monitoring tools. - Soft skills: Strong problem-solving, analytical, and communication skills.Downstream job descriptionDownstream bioprocessing handles the recovery and purification of the desired product from the cell culture harvest produced during the upstream phase. These roles are focused on creating a pure and safe final product.General responsibilities- Purification: Design and optimize purification processes using techniques like chromatography, filtration (e.g., tangential flow filtration), and centrifugation.(atleast 2 years) - Product recovery: Isolate and recover the target biological product (e.g., proteins, antibodies) from the complex mixture of cells, waste, and media. - Process optimization and scale-up: Develop and scale up purification methods from the lab to commercial manufacturing scale. - Quality control: Work closely with quality assurance and analytical teams to ensure the final product meets all quality and regulatory standards. - Formulation and filling: Prepare and package the final purified product, potentially involving polishing and formulation steps. - Troubleshooting: Investigate and resolve process-related issues that arise during purification and manufacturing.Key skills and qualifications- Education: A bachelor's or master's degree in biochemistry, bioprocess engineering, or a related field. - Experience: Significant experience in recombinant protein purification and downstream processing within a GMP environment. - Technical skills: Expertise in chromatography systems (e.g., AKTA) and filtration units. Familiarity with process analytical technology (PAT) is often beneficial. - Soft skills: Excellent problem-solving, project management, and cross-functional communication skills to collaborate effectively with other teams.