Senior Product Expert
Project Management and Technical Support for new and existing products for all Norgine sites, Contract Manufacturing Organisations (CMO) and partners, act as a subject matter expert for technical activities linked to a product or products.
KEY RESPONSIBILITIES & ACCOUNTABILITIES:
1. Act as a Technical subject matter expert for OSD products.
2. Project Leadership / Management and formal reporting of approved OSD projects for the introduction of new products, new processes, line extensions, technical transfers and continuous improvement initiatives.
3. Responsible for Product Lifecycle Management activities including Process Validation of OSD Products inline with ICHQ8-10.
4. Lead and/or provide technical support utilising lean six sigma techniques for investigations linked to Quality Events, Customer Complaints and IMC actions. Provide technical recommendations, co-ordinate and execute CAPA’s.
5. Generate Local and Global Change Controls. Provide impact assessments as a Technical Functional Expert. Lead / Support and/or coordinate the action plans.
6. Establish and maintain compliance for all products within the OSD Portfolio in accordance with GxP and company policies and procedures.
7. Manage the Technical roadmap for a product or group of products
1. Provision of technical expertise for planned activities and unplanned business issues.
2. Co-ordinate and participate in cross functional teams to complete root cause analysis utilising lean six sigma techniques. Reporting and presenting findings, outcomes and recommendations.
3. Planning of and Leadership / Management of GTM projects. Identifying and prioritising tasks on the critical path, influencing and supporting the project team and the wider business. Reporting against key project milestones and Norgine KPIs.
4. Manage and/or support process and analytical transfers for any transfers within or involving Norgine sites, CMOs and partners.
5. 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.
6. Author and execute Process Validation and Performance Qualification protocols for manufacturing processes. Author of Global Technical OSD strategy documents for EN Validation and Monitoring activities.
7. Author CMC sections of regulatory dossiers and support regulatory compliance initiatives including gap analysis, responding to RFIs, regulatory incidents and post approval commitments.
8. Contribute to the Technical strategy for the product portfolio
9. Manage and control costs in relation to Technical projects
1. Report directly to the Associate Technical Director.
2. Work cross functionally as a project lead or team member on approved projects with representatives from global and local departments, CMOs and partners.
3. Acts as a point of contact for the business for Technical information relating to product portfolio
4. Formal reporting of project status to Global Technical Management, Project Sponsors, Site and EN Directors, CMOs and Partners.
5. To work closely with the suppliers of raw materials in the development of new and alternative products as well as life cycle management of existing products.
6. Management and coordination of expert external resources.
7. Matrix Management for Product / Process Technologist roles
- Scientific Degree or equivalent possibly a higher qualification in a discipline related to pharmaceutical sciences.
- Extensive knowledge of the pharmaceutical industry with experience of solid dosage forms.
- Proven ability in managing complex Technical activities in a pharmaceutical environment
- Proven Project Management of line extensions, continuous improvement initiatives and technical transfers in a multinational environment.
- Knowledge of the Regulatory compliance requirements within Europe, Japan 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 (Other languages desirable e.g. French or German) with the 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.