Tech Transfer Lead

About No deviation

At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation.

We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development – empowering our team members to grow personally and professionally.

Position Overview

The Technology Transfer Lead will be responsible for leading and coordinating end-to-end technology transfer activities for pharmaceutical or biologics manufacturing processes. The role will act as the key interface between Process Development, MSAT, Manufacturing, Quality, Engineering, Validation, Supply Chain, and external partners to ensure successful transfer, scale-up, process readiness, and GMP implementation at the receiving site.

The candidate will be expected to manage transfer plans, assess process and facility readiness, coordinate technical risk assessments, support PPQ readiness, and ensure that transferred processes are robust, compliant, and aligned with project timelines.

Key Responsibilities

Technology Transfer & Project Leadership

• Lead technology transfer activities from sending site / process development team to receiving manufacturing site.
• Develop and manage the technology transfer plan, timeline, deliverables, risk register, and action tracker.
• Coordinate cross-functional activities across MSAT, Manufacturing, QA, QC, Engineering, Validation, Supply Chain, and Regulatory.
• Serve as the main technical and project interface between internal teams, external clients, CDMOs, vendors, and global stakeholders.
• Ensure transfer activities are executed in accordance with GMP, site procedures, regulatory expectations, and project milestones.

Process & Manufacturing Readiness

• Review process design, process description, batch records, control strategy, critical process parameters, critical quality attributes, and historical process performance data.
• Assess process fit to the receiving facility, including equipment capability, utilities, automation, facility layout, material flow, cleaning requirements, and operational constraints.
• Support gap assessments between sending site process requirements and receiving site capabilities.
• Coordinate process walkdowns, equipment readiness reviews, and manufacturing readiness assessments.
• Support scale-up, process adaptation, and process troubleshooting activities where required

Documentation & Technical Deliverables

• Prepare, review, and coordinate technology transfer documentation, including:
  Technology Transfer Plan
  Process Description / Process Transfer Report
  Gap Assessment
  Risk Assessment
  Facility / Equipment Fit Assessment
  Manufacturing Readiness Plan
  PPQ Readiness Documentation
  Batch Record Review
  Lessons Learned / Transfer Summary Report
  
• Review and support GMP documentation such as SOPs, MBRs, protocols, reports, change controls, deviations, CAPA, and validation documentation.
  
• Ensure all technical documentation is complete, accurate, traceable, and aligned with GMP expectations.

Validation, PPQ & Regulatory Support

• Support process validation strategy and PPQ readiness activities.
  
• Work with Validation / CQV teams to ensure equipment, utilities, automation, cleaning, and process systems are ready for GMP manufacturing.
  
• Support technical input for PPQ protocols, validation master plans, continued process verification, and process control strategy.
  
• Provide input for regulatory submissions, inspections, audit responses, and technical queries where required.
  
• Support deviation investigations, root cause analysis, impact assessments, and CAPA related to transferred processes.

Stakeholder Management

• Facilitate technical meetings, risk review sessions, readiness forums, and project governance updates.
  
• Communicate project progress, risks, blockers, and mitigation plans to management and stakeholders.
  
• Drive timely closure of open actions and ensure alignment between technical, quality, and operational teams.
  
• Build strong working relationships with internal and external stakeholders to ensure smooth transfer execution.

Required Qualifications

• Bachelor's degree in Chemical Engineering, Biochemical Engineering, Pharmaceutical Science, Biotechnology, Chemistry, Life Sciences, or related discipline.
  Master's degree or higher qualification would be advantageous. 
• Minimum 8–10 years of experience in pharmaceutical, biologics, vaccine, cell therapy, or sterile manufacturing environments.
• At least 3–5 years of direct experience in technology transfer, MSAT, process engineering, process validation, manufacturing science, or technical project leadership.
• Experience in GMP manufacturing, scale-up, process readiness, PPQ, validation, and cross-functional project execution.
• Prior experience in greenfield / brownfield start-up, new product introduction, CDMO transfer, or global site-to-site transfer would be advantageous.

Why join us?

• Generous Leave Policy.
• Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
• Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
• Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
• Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.

How to apply

Are you ready to play a key role in shaping the future of pharmaceutical solutions? If you're passionate about making an impact, we want you on our team!

Please submit your resume, outlining your qualifications and experience relevant to the role, here.