As an Associate Manager - MSAT based in Bangalore, India, your role involves being the single point of contact for downstream process from the manufacturing plant. You will guide teams in evaluating and executing new manufacturing technologies, ensuring effective transfer of processes and technologies, and providing support for dossier preparation and regulatory filing. Your responsibilities also include ensuring audit readiness, identifying risks associated with audits, and mitigating identified risks. Additionally, you will plan and facilitate scale-up, technology transfer, process validation, cleaning validation, and other related activities. Key Responsibilities: - Continuous monitoring and review of the downstream process of the DS manufacturing process - Performing continued process verification to ensure validated state of controls and consistent product quality - Evaluating downstream manufacturing process for improvement, optimization, and productivity increase - Working and communicating effectively with teams, CFTs, and partners for downstream process improvement activities - Authoring/reviewing process/QMS/regulatory filing documents and supporting data analysis for decision-making - Adhering to rules, regulations, procedures, data integrity, and compliance in all assigned activities Qualifications Required: - B Tech or M Tech in Biotech/Biochemical/Chemical or MSc Biotech/M Pharma - Minimum of 8 years of relevant experience in Biopharma MSAT or R&D - Mandatory downstream manufacturing experience - Extensive experience with GMP, cGMP, Regulatory Affairs, compliance, QC, etc. - Experience in team management is essential for this role If you have any additional details about the company in the job description, please provide that information so I can include it in the final output. As an Associate Manager - MSAT based in Bangalore, India, your role involves being the single point of contact for downstream process from the manufacturing plant. You will guide teams in evaluating and executing new manufacturing technologies, ensuring effective transfer of processes and technologies, and providing support for dossier preparation and regulatory filing. Your responsibilities also include ensuring audit readiness, identifying risks associated with audits, and mitigating identified risks. Additionally, you will plan and facilitate scale-up, technology transfer, process validation, cleaning validation, and other related activities. Key Responsibilities: - Continuous monitoring and review of the downstream process of the DS manufacturing process - Performing continued process verification to ensure validated state of controls and consistent product quality - Evaluating downstream manufacturing process for improvement, optimization, and productivity increase - Working and communicating effectively with teams, CFTs, and partners for downstream process improvement activities - Authoring/reviewing process/QMS/regulatory filing documents and supporting data analysis for decision-making - Adhering to rules, regulations, procedures, data integrity, and compliance in all assigned activities Qualifications Required: - B Tech or M Tech in Biotech/Biochemical/Chemical or MSc Biotech/M Pharma - Minimum of 8 years of relevant experience in Biopharma MSAT or R&D - Mandatory downstream manufacturing experience - Extensive experience with GMP, cGMP, Regulatory Affairs, compliance, QC, etc. - Experience in team management is essential for this role If you have any additional details about the company in the job description, please provide that information so I can include it in the final output.