Our client is a fast growing highly profitable multinational biopharmaceutical company with a large exciting pipeline of drug compounds at an advanced stage in research.
- The Manufacturing Senior Director (M.S.D.) role is a matrix role which leads a cross functional team that is responsible for the management, oversight and support of manufacturing of an assigned set of commercial or near commercial products. Engineering is the preferred qualification and experience for this appointment.
- The product team’s scope begins with planning for manufacture of phase III supplies from internal & external manufacturing sources and ends when the products leaves the dock of the manufacturer en-route to the distributors. The team’s scope is management of all value stream activities both internal and external to the company.
- Team members include cross functional representation from Quality Assurance, Supply Chain, Internal Manufacturing, Manufacturing Sciences, Regulatory Affairs, Quality Control, Analytical Support, Finance and Legal for the assigned products.
- The M.S.D. is the primary business owner for the manufacture of assigned products.
- The role works in close collaboration with the team’s Project Manager who is the primary owner of the team processes, tools, metrics and coordination of the product team’s activities.
- Day to day management, functional responsibility and budget responsibility of internal manufacturing will remain with the appropriate site leaders.
- Leads the assigned product Manufacturing Product Teams and appropriately manages the team dynamics.
- Sets and manages the agenda of the product team with input from the team functional members. Prioritizes issues for discussion & decision within the product team.
- In line with performance management system guidelines provides feedback and coaching to team members on their performance. Provides written feedback on team member’s performance to the appropriate functional lead during company performance review cycles.
- Drives day to day decision making and escalates on behalf of the product team to the Tech Opps Commercial & Supply governance team. Escalates on behalf of the team to senior management at the CMO site.
- Presents on behalf of the team, including leading the team during periodic product reviews (e.g. quarterly) with the Tech Ops Leadership team.
- Leads the business relationship between the Product team and the relevant CMO’s team at the site of manufacture.
- Resolves conflicts within the Product Team, provides and receives feedback to develop and maintain a high performing team and if necessary escalates team member performance related issues to functional line management.
- Develops a close working relationship and collaborative approach with the internal manufacturing sites and leadership teams.
- Working within a matrix cross functional environment, develops the supply plans, budgets for assigned products, revises & develops product roadmaps and sets annual objectives for both the product team and functional team members.
- Develops a clear medium to longer term strategy for a product including aspects of reliable supply, cost effectiveness, agility, responsiveness and innovative improvements.
- Working with supply chain to fully understand and make transparent supply and demand plans and consistent operating plans
- Manages and refreshes the business continuity plan process for relevant CMOs on a yearly basis.
- Working in collaboration with the functional team members develops multi-year strategic plans (e.g. 5 year plans) for assigned products.
- Maintain and assess opportunities & risks and align with the team’s activity prioritization.
- Ensure alignment of product portfolio strategy, planning & execution with management expectations & priorities.
- Ensure that the product team’s recommendations are brought to the appropriate governance forums for management buy-in and endorsement.
- Ensure cross functional partnerships and resources are leveraged effectively, with accountability, to achieve program objectives in alignment with corporate objectives.
- Drive collaboration and transparency across all functions and challenge team members to be strategic and inclusive in their long-term strategy planning.
- Collaborates with the relevant R&D and Global Molecule team governance to map the transition of responsibility for manufacturing from the development team to the Manufacturing Product team as planning for Phase III supplies begins.
- Lead the team to identify and drive manufacturing process improvements and change management within CMOs.
- Ensure Drug Substance, Drug Product, label & packaging and primary product contact materials are manufactured on time to the required quality.
- Meet appropriate inventory levels as defined by the business.
- Single point of contact for product for executive and functional management
- Ensure the team reports key metrics accurately, consistently and in a timely fashion, including risk register updates. Keep the VP & Head of External Manufacturing appraised of all significant issues relating to external manufacturing.
- Arrange regular business review meetings with CMOs, in collaboration with, Internal Manufacturing, Supply Chain, Quality, Manufacturing Sciences and others.
Agreements & Vendor Qualification
- Ownership of Master Services Agreement with CMO site.
- Partner with Quality to ensure that the appropriate Quality agreements are in place and that they are being adhered to using the Supplier Management process.
- In partnership with Legal ensure that all supplier relationships are governed by a legal contract.
- Excellent organizational, verbal, communication and presentation skills.
- Ability to effectively lead and participate on multi-disciplinary teams.
- Proven experience as successful, decisive leader in a strategic multifunctional environment
- Demonstration of a high level of business acumen.
- Successful experience collaborating with and facilitating project teams including cross-functional communication and decision making, while ensuring strong stakeholder alignment.
- Strong analytical, problem solving and contingency planning skills.
- Experience managing project budgets and timelines.
- Strong understanding of project management processes, risk management processes, pharmaceutical quality management systems and pharmaceutical regulations.
- Strong track-record of delivering results through effective team and peer leadership
- Ability to manage complex projects with ambitious milestones in high pressure circumstances
- Experience at managing collaborations, alliances or other relationships through influencing without direct authority
- Proven skills in navigating within a highly-matrixed environment
- Excellent communication skills, including executive presence and strong presentation skills
Education, Experience and Licenses
- Degree qualified in Engineering.
- MBA or Project Mgt qualification advantageous.
- Ideally 8+ years’ experience in pharmaceutical industry in one or more of the following functional areas: Supply Chain, Engineering, Quality, Manufacturing, Development, Regulatory Affairs.
- Experience of working in cross functional teams in a pharmaceutical industry environment.
Cv to email@example.com 01 2302400 www.rftgroup.ie