Lead Tech Transfer

Job Overview

We are looking for an experienced Technology Transfer professional to lead Technology Transfer activities for multiple manufacturing plant in France. The role will be responsible for project feasibility, planning, technology transfer, process validation, dossier support, client coordination and technical troubleshooting to ensure successful product transfer and commercialization.

Key Responsibilities

• Lead end-to-end Technology Transfer projects from feasibility and gap analysis through commercialization.
• Develop project plans, timelines and budgets, and ensure timely execution of project activities.
• Coordinate with Purchase, QC, QA, Production, DRA and other CFTs for materials, documentation and project deliverables.
• Lead technology transfer activities, including pre-SB batch meetings, trial batches, submission batches and process validation batches.
• Ensure timely closure of deviations, change controls and project-related incidents.
• Coordinate with clients and internal teams to address queries and ensure project milestones are achieved.
• Ensure timely availability of documents for dossier compilation, regulatory submission and product approval.
• Manage BOM preparation and ensure required project documentation is controlled and handed over to Plant QA.
• Provide technical support and troubleshooting for manufacturing processes.
• Ensure compliance with GxP, Data Integrity and applicable quality and regulatory requirements.

Reporting Structure

• Administrative Reporting to: Plant Head
• Functional Reporting: Group Tech Transfer Head India

Candidate Requirements

• 10 to 15 years of overall experience in Technology Transfer / Pharmaceutical Manufacturing.
• Minimum 5 years of experience in Injectable / Sterile pharmaceutical manufacturing.
• Strong experience in technology transfer, project management and product commercialization.
• Experience in feasibility assessment, gap analysis, project planning and budget management.
• Strong experience in process validation, trial batches, submission batches and stability batches.
• Experience in managing deviations, change controls, incidents and technical troubleshooting.
• Experience in dossier compilation and coordination with Regulatory Affairs / DRA teams.
• Strong understanding of GxP, Data Integrity, Quality and regulatory requirements.
• Proven experience in client coordination and cross-functional team management.
• Strong project management, problem-solving, communication and stakeholder management skills.

Location & Visa

• Position is based at our European subsidiary in France.
• Candidate is expected to be based in France for this role.
• France work visa support will be facilitated by the organization for the selected candidate.