Senior Product Expert

At Norgine, our colleagues Dare themselves to be different and try new things, Drive to achieve their goals and beyond, and Develop themselves and their community. We call it the 3D career at Norgine and it offers you a fully-rounded experience with no limits. Bring everything about yourself that you’re proud of, whether that’s your passion for making a difference, focus on others' well-being, or intellectual curiosity to unleash in a fast-paced environment and supportive community. In return, get a sense of belonging, a long-term career with ongoing development and upskilling, and a company that cares about people’s wellness as much as you do.

Norgine: Transforming Healthcare, Backed by Over a Century of Expertise. We have an exciting opportunity for a Senior Product Expert to join Norgine in Uxbridge, UK. This is a 12-month Fixed Term Contract. The person holding this position will report to the Technical Associate Director and be a member of the Manufacturing & Supply team. The core responsibility of the Senior Product Expert is to provide technical support for new and existing products across Norgine sites, Contract Manufacturing Organisations (CMO) and partners.

KEY RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:

• Lead investigations linked to Quality Events, Customer Complaints, IMC actions, Change Controls and CAPAs.
• Co-ordinate and execute associated CAPAs.
• Project management, formal reporting and implementation for the introduction of raw materials, new products, new processes, line extensions, technical transfers and CI initiatives.
• Development of project plans and management of risks and budgets.
• Responsible for lead multiple projects across internal manufacturing sites and with external partners (CDMOs/CROs), as required.
• Responsible for the execution of the Product Lifecycle Management (PLM) activities for assigned product portfolio of commercial products, including risk assessment and management.
• Act as a technical lead for products within their portfolio and provide technical support for assigned products and processes within their area of expertise.
• Author CMC sections of regulatory dossiers/supporting information for post approval changes and associated activities.
• Support of Change Controls with a potential impact on product quality within their assigned portfolio.
• Leading change controls for process/product changes and completion of technical functional impact assessments.
• Establish and maintain technical compliance for all designated products in accordance with GxP and company policies and procedures.

Requirements

Required:

• Degree in a scientific or engineering discipline.
• Previous experience in the pharmaceutical industry with solid experience of working within the industry and experience in matrix management.
• Understanding and implementation of Lean Six Sigma.
• Understanding of the Regulatory compliance requirements within Europe, Japan and the USA.
• Demonstrated experience in leading root cause analysis investigations.
• Ability to lead cross functional projects to deliver against key project milestones and deadlines.
• Inquisitive mindset with the drive to make improvements.
• Knowledge of common analytical and pharmacopeial techniques.
• Experience writing technical reports.
• Experience of supporting regulatory submissions and technical protocol/report writing.
• Ability to execute basic statistical analysis for data trending and provide recommendations of further actions.
• Thorough working knowledge of ICH Q8, Q9, Q10 and Q12 guidelines and Medical Device Regulation (MDR).
• Experience of multiple dose forms and product development.
• Coaching and mentoring of team members.

Desirable:

• Development and validation of analytical methods, management of stability programmes and protocol and report writing.
• Knowledge of drug substance manufacturing would be advantageous.
• Knowledge of development/and or manufacturing/process of multiple pharmaceutical dosage forms.

Our benefits may vary per location. Please liaise with the Norgine TA representative to obtain more information.