Major Activities  

• Develop technical subject matter expertise in the technical support team and wider manufacturing operations.   
• Project leadership/management and formal reporting of tech transfer and validation for each new product to establish manufacturing readiness for PPQ, launch and subsequent lifecycle management. 
• Responsible for product lifecycle management activities including process validation of processes in line with ICHQ8-10.   
• Lead and/or provide technical support using established problem solving techniques for investigations into quality events, customer complaints and IMC actions. Provide technical recommendations, co-ordinate and execute CAPA’s.   
• Management of change controls; providing impact assessments as a technical functional, coordinating input and support from development if required. Lead/support and/or coordinate the action plans.
• Responsible for ensuring that own work complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable procedures.
• Responsible for ensuring that own training is undertaken in a timely and GMP compliant manner before the task is undertaken.
• Responsible for ensuring that any GMP documentation assigned to me e.g. (but not limited to) Issues, CAPAs, Change Controls, BMRs & audit/inspection actions is closed timely and in a RFT state.

Main Team Activities

• Provision of technical expertise for planned activities and unplanned business issues. 
• Co-ordinate and participate in cross functional teams to complete root cause analysis using established problem solving techniques. Reporting and presenting findings, outcomes and recommendations. 
• Manage and/or support process and analytical transfers for any transfers from development, CMOs and partners into MeiraGTx manufacturing/testing facilities. 
• Leading the development and continuous improvement of manufacturing and analytical techniques for life cycle management in accordance with GxP, regulatory requirements and company policies and procedures. 
• Author/review/execution process validation and performance qualification protocols for manufacturing processes. 
• Author/review of relevant CMC sections of regulatory dossiers and support regulatory compliance initiatives including gap analysis, responding to RFIs, regulatory incidents and post approval commitments. 
• Contribute to the technical strategy for the product portfolio.

Relationships

• Reports to Technical Manager. 
• Works cross functionally and establish effective partnerships with in development, quality and manufacturing departments.
• Acts as a point of contact for the technical information in manufacturing and methods with clear understanding of the strengths of the developing SME network and how to access and use it.
• To work closely with the selected suppliers of raw materials and equipment during the development, tech transfer and implementation of new products, continuing through the life cycle management of existing products. 
• Management and coordination of expert external resources.

Job Background

• Scientific Degree or equivalent, preferably with a higher qualification in a discipline related to bio-pharmaceutical sciences. 
• Extensive industrial experience in Pharma/Bio within a GMP regulated environment.
• Demonstrated interpersonal skills with ability to work cross-functionally both with internal and external partners.
• Experience of transferring pharmaceutical products from Development into a GMP manufacturing environment and successfully gaining approval and launching new products commercially.
• Excellent communication skills.
• Knowledge of the Regulatory compliance requirements within Europe and the USA. 
• Demonstrated experience in the management of root cause analysis investigations utilising Lean/Six Sigma tools. Ability to manage, multiple, cross functional projects to deliver against key project milestones and deadlines. 
• Experience of managing workload of small teams to meet deadlines.
• Excellent verbal and written communication skills, in English.
• Ability to present effectively to groups. 
• Excellent influencing skills and ability to establish effective working relationships with personnel at all levels.  
• Thorough working knowledge of ICH guidelines and current Good Manufacturing Practices.