Job
Description
We are looking for a meticulous and experienced Technology Transfer Manager to spearhead the efficient transfer of technology for solid dosage forms at Evertogen Life Sciences . This pivotal role involves overseeing the seamless transition of OSD products from R&D or third-party development to our manufacturing plant, ensuring successful scale-up, unwavering regulatory compliance, and adherence to the highest quality standards. The ideal candidate will champion the preparation and review of critical technical documents, including technology transfer protocols, BMR/BPR, and process validation reports, while actively coordinating with cross-functional teams such as QA, QC, RA, and Production. This role demands a proactive individual adept at troubleshooting technical challenges, participating in scale-up batches, and driving continuous improvement initiatives. If you are passionate about optimizing pharmaceutical manufacturing processes, possess a strong understanding of QbD principles, and thrive in a collaborative environment, we encourage you to bring your expertise to Evertogen and contribute to our mission of delivering high-quality, affordable medications to the global market. Your contributions will directly impact our ability to meet client needs and maintain a diverse product portfolio. Job Details: Industry : OSD Formulation (Pharmaceuticals) Department : Technical Transfer Role : Assistant Manager Tech Transfer Location : Jadcherla Compensation : Up to 15 LPA Experience : 8+ years Employment Type : Full-time Qualification : M.Pharm / B.Pharm / M.Sc. in Pharma or related field Responsibilities: Technology Transfer Execution & Documentation: Lead technology transfer projects for solid dosage forms, ensuring adherence to timelines and quality standards. Develop technology transfer protocols covering critical process parameters and quality attributes. Oversee preparation and review of essential documentation (Technology Transfer Plans, Gap Analysis Reports, Process Flow Diagrams, BMR, BPR, Process Validation Reports). Coordinate cross-functional activities (R&D, Manufacturing, QA, RA) for seamless transfer and scale-up. Monitor process performance, addressing deviations or challenges. Maintain detailed records of technology transfer activities, ensuring compliance and data integrity. Ensure documentation adheres to cGMP, regulatory requirements (US FDA, EU EMA), and internal standards. Manage document archival and retrieval. Process Validation & Scale-Up: Participate in process validation activities for robust manufacturing processes of OSD Formulations. Analyze process data to identify CPPs and CQAs for process control strategies. Troubleshoot technical issues during scale-up and validation, implementing corrective actions. Evaluate the impact of process changes on product quality. Collaborate with engineering and production to optimize manufacturing processes. Ensure compliance with validation lifecycle management. Quality & Regulatory Compliance: Ensure compliance with cGMP, regulatory requirements (US FDA, EU EMA), and internal standards. Conduct risk assessments and implement mitigation strategies. Participate in audits, addressing findings and implementing corrective actions. Maintain understanding of regulatory requirements and best practices in OSD Formulation. Oversee CAPA implementation. Promote a culture of quality and compliance. Technical Troubleshooting & Continuous Improvement: Lead troubleshooting during initial commercial batches, identifying root causes and solutions. Apply problem-solving methodologies to address technical challenges in OSD Formulation. Identify process improvement opportunities. Utilize SPC tools to monitor process performance. Implement Lean Six Sigma principles. Champion continuous improvement. Cross-Functional Collaboration & Stakeholder Management: Coordinate with QA, QC, RA, and Production teams. Facilitate communication and collaboration among teams. Manage stakeholder expectations. Build relationships with internal and external partners. Generate progress reports, highlighting milestones, challenges, and risks. Present technical data to teams and management. Lead meetings to discuss project status and make decisions. Act as a liaison between R&D, Manufacturing, and stakeholders. General Expectations and Past Experiences: Possess 8+ years of hands-on experience in technology transfer within OSD manufacturing, demonstrating a strong understanding of the entire process lifecycle. Demonstrate proficiency in preparing and reviewing critical technical documents such as technology transfer protocols, BMR/BPR, and process validation reports. Exhibit a thorough understanding of Quality by Design (QbD) principles and their application in pharmaceutical manufacturing. Showcase strong technical troubleshooting skills with the ability to identify and resolve issues during scale-up and commercial manufacturing. Proven ability to coordinate and collaborate effectively with cross-functional teams, including QA, QC, RA, and Production. Demonstrate a solid understanding of regulatory guidelines (US FDA, EU EMA) and CGMP compliance requirements for pharmaceutical manufacturing. Experience risk assessment methodologies and CAPA management systems in a pharmaceutical setting.
