Manager / Sr. Manager - Technology Transfer & Process Improvement (API)

BIG PHARMA JOBS; Vapi; On-site; INR 2,500,000 - 5,000,000; Full time

Job summary

BIG PHARMA JOBS is seeking a Manager/Senior Manager for Technology Transfer & Process Improvement (API) in Vapi. The role ensures feasible tech transfers from R&D/external sources to commercial manufacturing, overseeing feasibility, scale-up, validation, and troubleshooting during production.

Reporting to Sr. VP Operations, you will bridge R&D, QA, QC, and Manufacturing to ensure regulatory compliance and right-first-time execution in a regulated API environment.

Qualifications

• B.E./B.Tech/M.Tech in Chemical Engineering or M.Sc. in Chemistry / Pharmaceutical Sciences.
• 08 to 12 years of API manufacturing or technical services experience, with at least 5 years in technology transfer and scale-up.

Responsibilities

• Review TT packages 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 technology transfer protocols, batch records, and process validation protocols.
• Ensure readiness of manufacturing equipment, utilities, and analytical methods for TT.
• Monitor critical process parameters, deviations, and CAPAs during scale-up and validation.
• Ensure timely documentation and reporting of TT activities per GMP and SOPs.
• Support training of plant teams for new processes being introduced.

Skills

Tech transfer

Scale-up

Process validation

QbD principles

FMEA

Regulatory awareness

Education

B.E./B.Tech/M.Tech in Chemical Engineering

M.Sc. in Chemistry / Pharmaceutical Sciences

Job description

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 companys goal to enter regulated markets.

Strategic Responsibilities

• Assess the technical feasibility and risk of new API technology transfers in alignment with the organizations 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

External Stakeholders: CDMOs / CMO Partners Licensing Partners Equipment Vendors Contract Testing Labs Regulatory Agencies (as required during audit support)

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 GMPCollaboration & Communication Stakeholder feedback on engagement and cross-functional coordination Innovation & Improvement Implementation of process improvements, cost savings, and knowledge transfer systems .