Technology Transfer Officer

Emcure Pharmaceuticals Limited; Sanand; On-site; INR 800,000 - 1,400,000; Full time

Job summary

Emcure Pharmaceuticals Limited in India (Gujarat, Sanand) invites an experienced Technology Transfer professional to support new product introductions and commercialization. You will coordinate TT activities, prepare and review BMRs/BPRs/SOPs, and ensure compliance with cGMP and regulatory standards.

Candidates should have 3–6 years in sterile injectable manufacturing, strong documentation and cross-functional coordination skills, and hands-on exposure to NPI, process validation, and scale-up.

Qualifications

• Bachelor's/Master's degree in Pharmacy, Life Sciences, Biotechnology, or related discipline.
• Strong understanding of sterile injectable manufacturing processes.
• Knowledge of Technology Transfer, Process Validation, Scale-up, Change Control, and Risk Assessment.
• Familiarity with cGMP, GDP, and regulatory compliance requirements.
• Strong documentation, communication, coordination, and cross-functional stakeholder management skills.
• Proficiency in MS Office and electronic documentation systems.
• 3–6 years of experience in the pharmaceutical industry.
• Mandatory experience in Sterile Injectable Manufacturing.
• Hands-on exposure to Technology Transfer, NPI, Process Validation, and Commercialization Activities.

Responsibilities

• Support Technology Transfer activities for new product introductions and commercial products.
• Prepare, review, and maintain TT documents, BMRs, BPRs, SOPs, protocols, and reports.
• Coordinate with R&D, Production, QA, QC, Engineering, Regulatory Affairs, Warehouse, and Packaging Development teams.
• Participate in process validation, batch execution, scale-up, and exhibit batch activities.
• Track project timelines and ensure timely completion of TT milestones.
• Support change control, deviation, CAPA, and risk assessment activities related to TT.
• Ensure compliance with cGMP, GDP, Data Integrity, and regulatory requirements.
• Assist in troubleshooting and implementation of process improvements during product transfer and commercialization.

Skills

Technology Transfer

Process Validation

Scale-up

Change Control

Risk Assessment

Documentation

Cross-functional Coordination

Education

Bachelor's/Master's in Pharmacy, Life Sciences or Biotechnology

Tools

MS Office

Electronic documentation systems

Job description

Industry: Pharmaceutical (Sterile Injectables)

Key Responsibilities:

• Support Technology Transfer (TT) activities for new product introductions and commercial products.
• Prepare, review, and maintain technology transfer documents, BMRs, BPRs, SOPs, protocols, and reports.
• Coordinate with R&D, Production, QA, QC, Engineering, Regulatory Affairs, Warehouse, and Packaging Development teams for seamless product transfer.
• Participate in process validation, batch execution, scale-up, and exhibit batch activities.
• Track project timelines and ensure timely completion of TT milestones.
• Support change control, deviation, CAPA, and risk assessment activities related to technology transfer.
• Ensure compliance with cGMP, GDP, Data Integrity, and regulatory requirements.
• Assist in troubleshooting and implementation of process improvements during product transfer and commercialization.

Qualifications & Skills:

• Bachelor's/Master's degree in Pharmacy, Life Sciences, Biotechnology, or related discipline.
• Strong understanding of sterile injectable manufacturing processes.
• Knowledge of Technology Transfer, Process Validation, Scale-up, Change Control, and Risk Assessment.
• Familiarity with cGMP, GDP, and regulatory compliance requirements.
• Strong documentation, communication, coordination, and cross-functional stakeholder management skills.
• Proficiency in MS Office and electronic documentation systems.

Experience Required:

• 3-6 years of experience in the pharmaceutical industry.
• Mandatory experience in Sterile Injectable Manufacturing.
• Hands-on exposure to Technology Transfer, New Product Introduction (NPI), Process Validation, and Commercialization Activities preferred.