Manager / Sr. Manager - Technology Transfer & Process Improvement (API)
Education: B.E./B.Tech/M.Tech in Chemical Engineering OR M.Sc. in Chemistry / Pharmaceutical Sciences.
Experience: 08 to 12 Years of experience in API manufacturing or technical services, with at least 5 years of hands-on experience in technology transfer and scale-up.
Individual Contributor Role
Location: Vapi
Reporting To: Solid Line to – Sr. VP Operations and Dotted Line to the Management
Department: Technical Services / Tech Transfer / Operations
Key Technical Competencies:
* Deep understanding of API manufacturing processes, unit operations, and GMP standards.
* Hands-on experience in tech transfer , scale-up , and process validation.
* Familiarity with QbD principles, risk assessment tools (e.g., FMEA), and process optimization techniques .
* Knowledge of regulatory requirements from the USFDA, EMA, and other global agencies.
* Ability to interpret analytical data and support method transfer issues.
Purpose of the Role: To ensure seamless and effective technology transfer of APIs from R&D or external sources to commercial manufacturing, focusing on feasibility assessment, scale-up, validation, and troubleshooting during production. The role bridges R&D, quality, and manufacturing to ensure regulatory compliance and right-first-time execution, aligned with the company’s goal to enter regulated markets.
Strategic Responsibilities:
* Assess the technical feasibility and risk of new API technology transfers in alignment with the organization’s regulatory and commercial strategy.
* Collaborate with cross-functional teams (R&D, QA, QC, Production, RA) to define tech transfer strategies aligned with GMP and regulatory expectations.
* Drive continuous improvement in scale-up, process understanding, and knowledge management to build a robust TT framework.
* Act as the technical SME during audits and regulatory inspections related to tech transfer and process validation.
Operational Responsibilities:
* Review technology transfer packages (TT dossiers, lab reports, process descriptions) from R&D or licensors for completeness and accuracy.
* Conduct pilot and scale-up batches, ensuring smooth handover from lab to plant.
* Lead or support troubleshooting during validation, exhibit, and commercial batches.
* Draft and review documents like technology transfer protocols, batch records, and process validation protocols.
* Ensure readiness of manufacturing equipment, utilities, and analytical methods for successful TT.
* Monitor critical process parameters, deviations, and CAPAs during scale-up and validation.
* Ensure timely documentation and reporting of TT activities in accordance with GMP and internal SOPs.
* Support training of plant teams for new processes being introduced.
Key Behavioral Competencies:
* Collaboration & Influence: Ability to work effectively across departments and external partners.
* Problem-Solving: Strong troubleshooting skills in a live manufacturing environment.
* Attention to Detail: Precision in process documentation and execution.
* Accountability: Ownership of outcomes across feasibility to commercial scale-up.
* Agility: Ability to respond and adapt to unexpected challenges or changes.
* Planning & Execution: Structured approach to project planning, resource coordination, and execution
Internal Stakeholders:
• R&D / Formulation Development
• Production / Engineering
• Quality Assurance & Quality Control
• Regulatory Affairs
• Supply Chain & Procurement
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External Stakeholders:
• CDMOs / CMO Partners
• Licensing Partners
• Equipment Vendors
• Contract Testing Labs
• Regulatory Agencies (as required during audit support)
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Core Performance Dimensions:
Dimension Success Indicators
Tech Transfer Timeliness Completion of tech transfers as per planned timelines without delays
Right-First-Time Execution % of batches executed without deviations or rework during scale-up and validation
Troubleshooting Effectiveness Resolution time and recurrence rate of process issues during scale-up
Documentation Quality Audit readiness of TT documentation and compliance with GMP
Collaboration & Communication Stakeholder feedback on engagement and cross-functional coordination
Innovation & Improvement Implementation of process improvements, cost savings, and knowledge transfer systems