OVERVIEW:

This job specification outlines the general responsibilities associated with the role of Manager QC Separation Sciences (QCSS) at Amgen Dun Laoghaire. This role will be responsible for managing the Separation Sciences 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.

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.

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

• Supervision/Management of QC Separation Sciences including In-process team
• Ensure the Separation Sciences area is operated in a safe manner
• Ensure all testing is performed in accordance with relevant procedures and within the required due date.
• Develop, revise and implement procedures that comply with appropriate regulatory requirements.
• Out of hours responder for Separation Sciences equipment (fridges /freezers / incubators)
• QC Representative for Separation Sciences at Amgen network meetings
• Developing and coaching the QC Separation Sciences team.
• Ensure timely completion of lab investigations and deviations through the relevant procedures.
• Keeps abreast of current Corporate and industry requirements and compliance trends as they pertain to Separation Sciences.
• Participate in regulatory agency inspections as required.
• Manage and contribute to the achievements of department productivity and quality goals.
• Conduct performance appraisal reviews for staff and identify training requirements for further development of colleagues.