Job Summary
We are seeking an experienced Technology Transfer Specialist to lead and support technology transfer activities from R&D to commercial manufacturing and between internal and external manufacturing sites. The role involves process scale-up, technology absorption, process validation, risk assessment, troubleshooting, and continuous improvement initiatives for Oral Solid Dosage (OSD) and Dermatological (Topical) products. The incumbent will work closely with cross-functional teams to ensure successful product commercialization, regulatory compliance, process robustness, and operational excellence.
Key Responsibilities
- Act as a Subject Matter Expert (SME) for technology transfer activities, facilitating seamless transfer of products and processes from R&D to manufacturing and between partner manufacturing sites.
- Lead technology absorption activities by collaborating with R&D, Manufacturing, Quality Assurance, Regulatory Affairs, and Supply Chain teams.
- Assess product and process feasibility for transfer and provide technical recommendations regarding manufacturing equipment, batch size determination, process design, material handling, containment systems, environmental controls, and tooling requirements.
- Prepare, review, and approve process validation protocols, validation reports, technology transfer documents, process monitoring reports, risk assessments, and other GMP-compliant documentation.
- Execute and monitor scale-up, exhibit, registration, validation, and commercial manufacturing batches while ensuring compliance with approved processes and quality standards.
- Coordinate on-site and remote technology transfer support for customers and partner manufacturing facilities.
- Support customer and manufacturing teams in troubleshooting process-related issues during technology transfer, scale-up, validation, and commercial production.
- Conduct process investigations, root cause analyses, and risk assessments for deviations and manufacturing challenges.
- Design and execute laboratory studies and process improvement experiments to validate root causes and implement CAPA.
- Prepare technical investigation reports and collaborate with Manufacturing and Quality teams to implement process improvements.
- Evaluate the technical capabilities and suitability of external development and manufacturing facilities.
- Provide technical and cost-related inputs on equipment, materials, and manufacturing requirements.
- Ensure adherence to cGMP, QMS requirements, regulatory requirements, and internal quality standards.
- Drive continuous improvement initiatives focused on process robustness, manufacturing efficiency, and cost optimization.
Educational qualification:
. B.Pharm / M.Pharm (Pharmaceutics preferred)
. Additional certifications in Process Validation, Quality Systems, Lean Six Sigma, or Project Management will be an added advantage.
Minimum work experience: 7-15 years of experience
Skills & attributes:
Technical Skills
- Strong knowledge of cGMP, regulatory requirements, and pharmaceutical manufacturing practices.
- Expertise in technology transfer and process scale-up from development to commercial manufacturing.
- Experience in transferring technologies between internal and external manufacturing sites.
- Sound understanding of process validation, continued process verification (CPV), and lifecycle management.
- Proficiency in investigation management, root cause analysis, CAPA implementation, and risk assessment methodologies.
- Strong understanding of Quality Management Systems (QMS), deviation management, change control, and compliance requirements.
- Handled regulatory agency deficiency responses, driving timely closure and continuous compliance improvements.
- Technical expertise in manufacturing equipment selection, process design, facility requirements, containment systems, and environmental controls.
- Excellent problem-solving, analytical, and troubleshooting capabilities.
- Strong communication, stakeholder management, and cross-functional collaboration skills.
- Ability to manage multiple projects and technology transfers simultaneously while meeting timelines and business objectives.
Behavioural skills
. Ability to convey complex processes and technical information clearly to diverse audiences, including team members, management, and cross-functional teams.
. Good Interpersonal skills and capacity to work collaboratively with cross-functional teams, like R&D, manufacturing, SCM, quality assurance, regulatory affairs, and others.
. Strong analytical and problem-solving skills to address challenges.
. Demonstrates integrity by consistently following protocols, exhibiting trustworthiness and reliability.
. Takes responsibility and maintains a disciplined and agile approach to execution.
