Technology Transfer Manager

Key Responsibilities:

Process Development & Evaluation

• Assess and optimise manufacturing processes for oral liquid and suspension dosage forms, ensuring compliance with cGMP and MHRA expectations.
• Evaluate existing processes for efficiency, reproducibility, and scalability.
• Generate process flow diagrams, mass balance calculations, and risk assessments (e.g. FMEAs).
• Support the development of control strategies in line with QbD principles.

Technology Transfer & Scale-Up

• Lead or support the technical transfer of new products from R&D, CMOs, or other manufacturing sites into the facility.
• Collaborate with formulation scientists, analytical teams, and quality units to ensure successful transfer and scale-up.
• Translate lab/pilot-scale processes into commercial-scale batch manufacturing using appropriate scaling principles (e.g. geometric, kLa, shear).

Equipment Assessment & Commissioning

• Evaluate, select, and support the commissioning and qualification (IQ/OQ/PQ) of equipment used in manufacturing of oral liquids and suspensions.
• Work with Engineering and Validation teams to introduce new manufacturing equipment or modify existing systems.
• Conduct capability assessments and ensure equipment is fit for purpose and compliant with regulatory requirements.

Process Validation & Documentation

• Design and execute process validation protocols (PPQ) for new and existing products in compliance with Annex 15 and ICH Q8/Q9/Q10.
• Prepare or review technical documentation, including batch records, validation reports, and change control justifications.
• Support Continued Process Verification (CPV) activities and trending.

Technical Troubleshooting & Support

• Provide on-the-floor technical support during production campaigns, including investigations of batch deviations, process failures, or equipment malfunctions.
• Lead or support root cause analysis and CAPA implementation.
• Use data-driven approaches to troubleshoot mixing, dispersion, solubilisation, or viscosity-related process challenges.

Scientific Expertise

• Act as subject matter expert (SME) on process science, especially challenges related to formulation behaviour at scale, such as sedimentation, viscosity variation, pH shifts, and homogeneity.
• Evaluate raw material variability and its impact on product/process performance.
• Provide scientific input into development reports, risk assessments, and product lifecycle documentation.

Key Interfaces:

• Production / Manufacturing Operations
• Quality Assurance / Quality Control
• Validation / Engineering
• Research & Development / Formulation Scientists
• Regulatory Affairs
• Supply Chain / Procurement
• Contract Manufacturing Organisations (CMOs)

Qualifications & Experience:

Essential:

• BSc or MSc in Chemical Engineering, Pharmaceutical Sciences, or related scientific/engineering discipline.
• Experience working in a GMP pharmaceutical manufacturing environment.
• Hands-on experience with oral liquid and/or suspension manufacturing processes.
• Solid understanding of scale-up principles, process validation, and regulatory expectations (MHRA, EMA, FDA).
• Familiarity with pharmaceutical equipment such as mixers, homogenisers, liquid fillers, and storage vessels.
• Experience in technical transfer and troubleshooting manufacturing issues.

Desirable:

• Experience with statistical process control (SPC), multivariate analysis, or design of experiments (DoE).
• Understanding of QbD, ICH Q8-Q11 principles, and Annex 15 (EU GMP).
• Experience working in a cross-functional technical/engineering role within the pharmaceutical industry.

Key Skills & Competencies:

• Strong analytical and problem-solving abilities.
• Excellent communication skills, both written and verbal.
• Ability to work cross-functionally in a matrix environment.
• Proactive mindset with attention to detail.
• Comfortable working on shop floor and in technical documentation environments.
• Strong project management and organisational skills.