Tech Transfer and Validation Manager
DEPARTMENT: MANUFACTURING & SUPPLY CHAIN
LINE MANAGER / SUPERVISOR JOB TITLE / POSITION – SVP MANUFACTURING & SUPPLY CHAIN
Purpose of Job
To establish and develop the processes and build and lead the team required to Tech Transfer New Products and Analytical methods from Development into Manufacturing in line with CMC registration and Product launch milestones.
To build the organisation and processes for Project Management and Technical Support in Product Lifecycle Management activities including Validation of Manufacturing Processes and Methods in line with ICHQ8-10.
- Develop Technical subject matter expertise in the Technical team and wider manufacturing operations.
- Project Leadership/ Management arid formal reporting of tech transfer and validation for each new product to establish manufacturing readiness for PPQ, Launch and subsequent lifecycle
- 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 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 Include 8-12 main activities
MAIN Team Activities
- Provision of technical expertise for planned activities and unplanned business
- Coordinate and participate in cross-functional teams to complete root cause analysis using established problem-solving techniques. Reporting and presenting findings, outcomes and
- 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 RFls, regulatory incidents and post approval commitments.
- Contribute to the Technical strategy for the product portfolio
- Manage and control costs in relation to Technical resources and projects
- Report directly to the SVP Manufacturing and
- Manage a team of tech transfer/validation specialists
- Work cross functionally as a strong leader and establish effective partnerships with functional leads in Development, Quality and
- 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
- 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
Key Job Competencies
- Leadership – exhibits confidence in self and others; inspires and motivates others to perform well; effectively influences actions and opinions of others; accepts feedback from others; gives appropriate recognition to
- Problem Solving – Identifies and resolves problems in a timely manner; gathers and analyzes information skillfully; develops alternative solutions and works well in group problem solving
- Commercial acumen- gets involved in strategic decision-making within the business as an influencer. Able to understand company finances, resourcing and the ultimate aims of the business
- Change Management – Develops workable implementation plans; communicates changes effectively; builds commitment and overcomes resistance; prepares and supports those affected by change; monitors transition and evaluates
- Cost Consciousness – works within approved budget; develops and implements cost saving measures; contributes to profits and revenue; conserves organizational
- Motivation – sets and achieves challenging goals; demonstrates persistence and overcomes obstacles; measures self against standard of excellence;
- Planning/Organizing – prioritizes and plans work activities; uses time efficiently; plans for additional resources; sets goals and objectives; organizes or schedules other people and their tasks; develops realistic action
- Professionalism – approaches others in a tactful manner; reacts well under pressure; treats others with respect and consideration regardless of their status or position; accepts responsibility for own actions; follows through on commitments.
- Quality Management – looks for ways to improve and promote quality; demonstrates accuracy and thoroughness.
- Innovation – displays original thinking and creativity; meets challenges with resourcefulness; generates suggestions for improving work; develops innovative approaches and
- Oral Communication – speaks clearly and persuasively in positive or negative situations; listens and gets clarification; responds well to questions; demonstrates good presentation skills; participates effectively in meetings.
- Written Communication – writes clearly and informatively; edits work for spelling and grammar; varies writing style to meet needs; presents numerical data effectively; able to read and interpret written
- Scientific Degree or equivalent, preferably with a higher qualification in a discipline related to bio pharmaceutical
- Extensive industrial experience in Pharma/Bio within a GMP regulated
- 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
- Knowledge of the Regulatory compliance requirements within Europe, Japan and the
- Demonstrated experience in the management of root cause analysis investigations utilising Lean/Six Sigma
- 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