Technology Transfer Manager

Technology Transfer Manager

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.