Technology Transfer Consultant

Proclinical is seeking a Technology Transfer Consultant with extensive experience within the Pharmaceutical or Biotechnology industries.

As Technology Transfer Consultant, you will be responsible for managing the technology transfer of Pharma 's commercial products to third party CMOs. Projects include tech transfer of API supply, drug product manufacturing, packaging, and QC testing responsibilities.

You will also coordinate and execute technology transfer activities at CMOs to continuously improve Pharma 's manufacturing supply chain, both in terms of product robustness as well as in terms of production yield and cost. You will ensure technical capabilities are developed and are in place at CMOs and suppliers to meet cGMP and regulatory requirements.

Finally, you will effectively manage matrix teams, ensuring adherence to cGMP best practices, quality and product excellence throughout the manufacturing process. You will work in close collaboration with the outsourced manufacturing and supplier network, Supply Chain, Quality, Logistics, Regulatory Affairs, Manufacturing and Commercial teams to ensure the adoption of 'One Strategy' and ensure delivery of tech transfer projects in a timely and integrated manner.

This is a remote position.

Job Responsibilities:

• Reporting to the Director of MS&T (Manufacturing, Science & Technology), this role will be responsible for coordinating and executing tech transfer projects at CMOs
• Developing robust project plans in conjunction with all stakeholders to transfer products to other sites.
• Planning and successfully executing transfer and validation of manufacturing activities in compliance with GMP and regulatory requirements.
• Proactively managing remote matrix teams at CMOs to execute tech transfer projects to agree timelines.
• Actively engaging with R&D and Manufacturing site resources to ensure all Pharma 's
• manufacturing needs are met including readiness for new product introductions
• Compiling technical documentation and prepare side-by-side comparison report for tech transfer.
• Ensuring that the technical contents of the work packages conducted at third-party manufacturers are in line with appropriate regulatory and ICH standards, i.e. ICH Q8, Q9 and Q10.
• Ensuring technical capabilities are in place across remote teams - CMO sites have the capabilities to support the product life cycle through material changes, scale up/down, validation, optimisation, and OPEX/cost reduction/Value improvement initiatives for New Product introductions.
• Ensuring CMO sites has the capabilities to conduct Product Robustness assessments, risk
• Representing MS&T across the company's network and externally through interfaces at all levels from front-line to senior management.
• Participating in vendor audits and support pre-approval inspections, as necessary.
• Assisting in production planning and raw material procurement.
• Providing technical support, monitoring, continuous improvement, and troubleshooting of
• manufacturing processes and analytical methods.
• Critically reviewing the technical work packages at CMOs, ensuring compliance with product specification, licence, and applicable regulatory requirements
• Writing, reviewing, approving and/or executing SOPs, master batch records, validation protocols, project summary reports, and vendor audit reports,
• Ensuring compliance with Pharma 's QMS, review Deviations, Investigations, and CAPAs.
• Leading or participating in key investigations related to lot/batch release.
• Will be hands-on as needed for knowledge transfer oversight and technical support.
• Reviewing quotes, work orders, and invoices and managing work packages within budget.

Skills and Requirements:

• BSc and MSc or PhD in Chemistry, Biochemical Engineering or related field.
• At least 10 years' experience in Pharmaceutical or Biotechnology industry.
• At least 5 years' experience as a technical professional supporting commercial products.
• Experience of manufacturing process scale-up, process validation, tech transfer and new product introduction.
• Knowledge of GMP compliance.
• Can lead authoritatively in a complex internal/external environment with multiple stakeholders.
• Organisational effectiveness - must understand how the organisation works and can navigate effectively through formal/informal channels.
• Able to make sound decisions in a complex environment based on mix of analysis, experience and judgement.
• Ability to see beyond own function to understand business objectives and implement best practices.
• Proven track record in leading in-direct teams with cross functional scope.
• Strong communication skills to internal and external audiences.
• Demonstrable multitasking, project management, and execution skills.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.
• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency in MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Kelechi Dyke at +44 203 854 0200 or upload your CV on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

#LI-KD2