R&D Manager (Clinical Nutrition) - On-Market Solutions Lifecycle Management

R&D Manager (Clinical Nutrition) - On-Market Solutions Lifecycle Management

Baxter International

Marsa, Malta

Summary:

Forming part of a group of technical experts (SMEs) responsible for the continuity, quality, compliance & profitability of Nutrition Solutions on-market products. Support the execution of product changes in compliance with international regulations and quality standards; working with cross-functional teams and/or SMEs to ensure problem-solving, decision-making and change execution occur within project timelines.

Essential Duties and Responsibilities:

• Lead a team of scientists responsible for the management and execution of lifecycle design supporting activities for the Clinical Nutrition Solutions On-Market products.
• Provide leadership to team members, guiding them in terms of prioritization, problem resolution, process clarification, referrals to appropriate experts, etc. Ensure that personal and team objectives align with key Segment initiatives;
• Manage routine and complex supplier notice of changes (SNCs), change control records, product code obsolescence and product end of life (EOL) activities in addition to general technical administrative tasks;
• Organize, plan and execute product changes in compliance with international regulations and quality standards; coordinate and set up cross-functional team meetings to ensure change execution, problem-solving and decision making;
• Independently plan, execute, and manage project(s) that span multiple disciplines with team, cross functions and regions. Applying a solid understanding of theories/practices including those from other disciplines outside the primary area of expertise;
• Employ project management tools to manage project schedules and budgets against milestones; review and apply best-demonstrated practices, team processes, and improve operational efficiency. Identify and resolve issues that may jeopardize project schedules and/or improve project timelines;
• Build and maintain a metrics system to track the progress of operational activities and critical KPIs. Summarize and report out results in both oral and written formats to manager and Senior Leadership team (SLT), as required;
• Manage market enhancements and operational improvements. Participate in development and improvement activities associated with the design, manufacturing and control of products. Prepare technical protocols and reports;
• Adhere to the Quality Systems, understand and apply applicable corporate, divisional and departmental procedures as required.

Competences:

Good knowledge of:

• Product development stages and life cycle management: development, stability, clinical, registration, process transfer, production, suppliers, customer service. Design Control documentation and process. Statistical Analysis and/or Lean/Six Sigma tools;
• International/regional/national regulations and standards. Self-motivated, resourceful, and flexible. A self-starter is imperative. Strong interpersonal communication skills and ability to communicate effectively with internal and external customers. Skilled at presentations within the business/technical community;
• Technical writing proficiency to author internal reports and scientific papers. Strong human relation skills for group leadership, individual leadership, and project management. Ability to lead, manage and facilitate cross-function/division teams;
• Ability to break down technical processes and effectively delegate to junior team members. Strong quantitative and qualitative assessment skills and critical thinking skills in support of analyzing and solving complex problems through innovative thought and experience;
• Demonstrated ability to lead technical projects through successful outcomes. Ability to design and implement projects/studies outside area of expertise. Demonstrates flexibility and ability to shift gears between projects comfortably. Fluent in English.

Education and/or Experience:

• Bachelor’s degree in a scientific discipline (Chemistry/Biology/Pharmaceutics/Chemical Engineering) with 10+ years experience, Masters degree with 5+ years experience or PhD with 1+ year experience;
• Relevant experience is preferably in the pharmaceutical industry with a broad background in solutions/drug development/lifecycle management. Familiarity with the utilization of analytical instrumentation in test methods and/or process engineering is desirable.