Associate Technical Director
Norgine, United Kingdom
Job Description
SCOPE OF ROLE:
- Geographical: Global
- Managerial span of control: Management of portfolio Technical function
- Direct reports: Senior Product Expert(s), Product Expert(s), Technical Support Officer(s), Analytical Specialist(s), Validation Specialist(s)
MAIN PURPOSE:
This is a highly complex area where the role requires strategic and direct technical expertise applied through the entire product life cycle, providing an essential technical link from Ramp;D through clinical manufacturing, process qualification, commercial manufacturing, continuous improvement across Norgine Mamp;S and also with an extensive Contract Manufacturing Organisation spanning worldwide.
As a Senior Leader within Mamp;S, the job holder must provide direction to ensure Norgine Business Objectives are met. This direction will have a direct financial impact on Norgine financials. For example, the Associate Technical Director for PEG products will be directly responsible for the strategy of the PEG portfolio within Norgine Mamp;S. This includes being an effective alliance partner and understanding and accommodating multiple challenging markets and customers spanning Europe, US, Russia, Japan etc. The strategic direction for each product within the portfolio requires the jobholder to consider multiple potential sites of manufacture within Norgine Mamp;S direct sites (Dreux and Hengoed) as well as an extensive worldwide Contract Manufacturing Operations Network. This will have direct impact on millions of patients worldwide and potential financial impact on Norgine business typically exceeding 50M.
The role also includes managing complex teams of managers and also highly skilled technical experts.
KEY RESPONSIBILITIES amp; ACCOUNTABILITIES:
- Provide manufacturing and supply expertise / advanced technical support utilising existing and new knowledge to solve complex business issues whilst ensuring alignment to Norgine business initiatives / processes such as NPDI or Vision 2020.
- Demonstrating leadership by understanding and showing commitment to Norgine’s business strategies and providing leadership and direction to other members within Global Technical by alignment with Mamp;S objectives.
- Leading and / or providing technical support into investigations linked to Quality Events, Customer Complaints and IMC actions. Provide technical recommendations, co-ordination and execution of CAPA’s.
- Project implementation leadership and formal reporting of approved Global Technical projects for the introduction of new products, new processes, line extensions, technical transfers and continuous improvement initiatives.
- Accountability for the Technical strategies relating to the Manufacture / Packaging and Supply of the Norgine portfolio of products under Technical management.
- Accountability in maintaining up to date knowledge within the group regarding current and potential future manufacturing and / or packaging technologies.
- Responsible for the budgetary control relating to the Technical project portfolio
- Lead a group of highly skilled Technical experts to ensure Mamp;S amp; team objectives are developed and prioritised to meet the overall Norgine business strategy.
- Accountable for ensuring Global Technical activities are appropriately resourced during the development and implementation of NPDI and post launch Mamp;S activities.
- Ensuring the team, and the projects undertaken by them, comply with Health, Safety and Environment good practice.
- The provision of technical expertise and support to all Norgine manufacturing sites including third party contractors for existing and new products.
- Management of process (production and analytical) improvement / optimisation programmes.
- Providing input to ensure the manufacturability and commerciality of new, in-licenced or existing products, through the application of ICH Q8, Q9, Q10 guidelines.
- Accountable for product process, packaging design and technical specifications, to include commercial, development, and prototype designs.
- Accountable for providing technical input into the selection and development of the supply chain including distribution.
- Accountable for ensuring Quality by Design principles are followed and built into the final manufactured product.
- Working with sites to support any pre-approval inspection activity.
- Management of the technical aspects of production and supply of launch stock to first market(s) for either new products or following significant changes that could possibly impact supply post launch. (KPI’s here include launch on time and no market OOS’s)
- Oversee the technical transfer of drug substances and drug products to alternative sites of manufacture.
- Supporting compliance initiatives to ensure the raw