Amgen, Dun Laoghaire - Dublin

Overview:

This role will be responsible for managing the Separation Sciences and in-process team while owning, facilitating, and undertaking activities pertaining to QCSS within QC. The successful candidate will focus on compliance, continuous improvement and implementing a lean culture and Right First Time (RFT) for QCSS duties and testing, including release/stability/in process of commercial product. The role also represents the QC unit by liaising with internal and external stake holders

The site is focused on continuous improvement of all work processes and practices and all colleagues are required to be flexible in this regard. This means that they may be asked to carry out additional work functions that are not described in this specification but are associated with their role.

Key Responsibilities

• Supervision/Management of QC Separation Sciences including In-process team
• Responsible for providing Quality oversight to ensure that operations products are manufactured, tested, stored and distributed according to current cGMP, GDP and other applicable regulations
• Provides coaching, feedback and mentoring to ensure team development.
• Builds relationships and collaborates cross functionally with ADL and Network colleagues to share lessons learned and improvements
• Ensures deviations from established procedures are investigated and documented per procedure
• Represents QC during Audits and Inspections regarding preparation and participation
• Represents QC at site and network level .
• Supports Continuous Improvement and Error management initiatives, programs and projects.
• Works with minimal supervision but knows when to escalate or look for support

Primary knowledge, skills, competencies and relevant experience

Knowledge:

Broad technical knowledge within Separation Sciences area and expanding knowledge of related disciplinary areas, specific knowledge HPLC, Capillary Electrophoresis and SDS/IEF Gels is an advantage.

Recognizes and understands the cross-dependencies of the technologies and understands the impacts on the organization

Enhances own knowledge through understanding business trends and objectives

Knowledge of industry and business principles

Understands the core business process and purpose of the functional area in Amgen's commercialization process

Developing own project management techniques

Problem Solving:

Applies analytical skills to evaluate and interpret complex situations/ problems using multiple sources of information. Creates new procedures and processes to drive desired results Handles diverse scope of issues that require evaluation of a variety of factors including current business trends

Autonomy:

Managerial/Supervisory experience with a proven record in a Supervisor/ Team Lead role. Experience leading cross-functional teams is desirable. Work is guided by operational and project objectives.

Manages multiple assignments and processes.

Independently determines approach to project

May be responsible for specific programs and/or. projects Independently develops solutions that are thorough, practical, and consistent with functional objectives

Contribution:

Contributes to work group/team by ensuring quality of tasks/services provided by self and others with a strong focus on RFT and Lean Provides training and guidance to others Extends capabilities by working closely with senior staff/experts within and outside the internal organization

Skills:

• Lead with initiatives to identify and drive improvements Communication skills (verbal and written) at all levels.
• Strong Technical writing skills for GMP documentation (e.g. investigations, procedures, change controls)
• Presentation skills.
• Escalate issues professionally and in a timely basis and know when to escalate
• Decision Making skills – will be required to make decisions independently.
• Teamwork, Coaching and motivating others, Negotiation and Influence skills, Planning and Organisation skills, Investigation skills.
• Demonstrated ability to interact with regulatory agencies Experience working with interdepartmental and cross functional teams and influencing decisions.

Relevant experience:

• Bachelor’s degree in a Science related field is required. 
• 6+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry, with of 2 – 3 years of specific QC laboratory management experience is desirable. 
• Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.
• Possess key competencies to include planning/organisation, problem solving, communication, teamwork, flexibility, coaching and motivating. Proven experience of leading teams

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