Job Description
The Supplier Relationship and Manufacturing group manages supplier relationships within the Biologics Operating Unit organisation to achieve objectives
Responsibilities
The SRM Lead may be expected to:
Develop and manage Suppliers for clinical/commercial API, DP and finished dose manufacturing globally aligning to SC strategy
Development and implementation of ways of working/business processes and guidelines to define standard ways of working across the SRM team
Manage CMO lifecycle including selection, technology transfer, manufacturing, and decommissioning.
Lead and/or contribute to tactical and strategic sourcing activity
Gather and share market intelligence on the external market place
Manage multiple projects in support of the Bio Op U objectives
Ability to travel domestically and internationally up to 25+%.
Manage existing supplier relationships, including the day to day management, Business Review meetings and contractual negotiations
Work with stakeholders to develop and monitor short-term and long-term plans, including timelines, budget forecasts, for achieving department strategies.
Partner with stakeholders to select among existing or develop new CMOs who can meet program requirements and augment internal or external manufacturing network capabilities.
Develop and strengthen mutually beneficial relationships with members of CMO network
Work with other functional leads to ensure that technology, operations, and quality expectations are accurately represented in requests for proposals, and then reflected in subsequent contracts and agreements with CMO?s.
Support for PD during technology transfer, scale up and engineering runs.
Independently negotiate moderate scope manufacturing supply agreements meeting supply, quality, financial and risk mitigation requirements.
Proactively identify CMO activity-related risks that may impact program commitments: supply delivery dates, program milestones, or goals. Work with CMOs and cross-functional business partners to develop robust mitigation and contingency plans.
Identify, elevate, and work with stakeholders and CMO?s to facilitate resolution of manufacturing, analytical, supply chain, quality, or issues that may arise.
Monitor and drive adherence to and CMO contractual commitments, obligations, and processes, including milestone dates, financial terms, and production schedules both internally and externally.
Establish, track, monitor, and report performance metrics related to operations, quality, cost, and customer service. Develop and distribute periodic reports on CMO performance, issues, risks, and schedules of key activities, events, or milestones.
Support and executed quality systems as required.
Deliver business benefit through annually set savings targets
Manage new product introductions/new launches within the supply base
Supports implementation of Continuous Improvement initiatives (including Lean Sigma) at suppliers/CMO?s
Keeps current with the industry & regulatory compliance trends and publications
Performs other assignments as requested by the SRM leadership team
Comply with appropriate legislation and policies including, but not limited to:
Sarbanes Oxley, Environmental Safety & Health, and Corporate Responsibility
Oversee budgets, approve C/O and request PO.
Education & Experience Requirements
Bachelor/ Master?s Degree in Engineering, Biotechnology, Business or scientific field
Minimum of 7 years relevant clinical/commercial Pharmaceutical experience
Strong project management, problem solving, decision making, collaboration, influence, and facilitation skills.
Experience leading cross-functional teams to overcome hurdles and deliver project results on time and as expected.
Interpersonal skills necessary to develop effective working relationships with internal stakeholders, CMOs, and represent the External manufacturing organization on cross-functional and cross-cultural project teams.
A working knowledge of biotech/pharma manufacturing operations, product and process development, and supply chain operations
Proven negotiation skills in Drug Product Contract Manufacturing, API, Contract Testing areas
Ability to effectively communicate and persuade others at every level to accomplish challenging tasks
Demonstrable cGMP Manufacturing knowledge working in a cGMP manufacturing environment
Knowledge in FDA & EU (c) GMP compliance
Able to negotiate and manage contracts
Experienced in risk management processes
Excellent clinical/commercial API, DP & FDP sourcing and manufacturing knowledge.
For further information on this Supplier Relationship & Manufacturing Lead
position please contact Laurentina Kennedy at The RFT Group on 01 2302400 Check out all our open jobs on our Recruitment website: www.rftgroup.ie
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