Senior Manager, Process Development, External Process Engineering

6 days ago

Dublin, Ireland Amgen Inc. (IR) Full time

The Principal Engineer role is based at Amgen Dun Laoghaire (ADL) and reports to the Director of Drug Product Process Development. The successful candidate will manage a team of subject matter experts supporting contract manufacturing partners across Europe, focusing on process development and commercial support for parenteral drug product manufacturing. The position encompasses technical and managerial leadership, ensuring efficient execution of manufacturing processes and supporting new product introductions, lifecycle changes, and ongoing commercial and clinical production and development. **Key Responsibilities:**Project Management: Oversee multiple projects, evaluate resource requirements, and deliver against organisational goals and project milestones. Develop and communicate recommendations and risk mitigations to governance bodies. Relationship Building: Create synergies with senior managers and leaders with the internal cross functional organisation. Visit contract manufacturing sites to support key production milestones and strengthen partnerships. The successful candidate for this role will bring the following education, skills and experienceBasic Qualifications: 10 + years of experience in support of Commercial Protein Drug Product (DP) processing in specific areas such as Sterile Processing, Process Characterisation, Tech Transfer or Validation. BSc in science, engineering or equivalent with additionally qualifications (Masters /PhD).Master’s degree & 10 years of directly related experience OR doctorate degree & 7 years of directly related experience.Proven problem-solving ability.Excellent oral and written communications skills.Full clean driving licence and the ability to travel freely within Europe are required to facilitate business travel needs.Preferred Qualifications:Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion. Strong skills in applying fundamental engineering and scientific principles to the design and implementation of protein freeze-thawing, filtration, mixing, filling, and/or lyophilization processes. Knowledge of protein biochemistry with regard to chemical and physical stability.Skills and Competencies:Exceptional leadership and team management abilities.Strong problem-solving and analytical skills.Excellent communication and collaboration skills, with the ability to influence at all organisational levels.Ability to operate effectively in a highly matrixed organisation.In addition to a competitive salary structure, Amgen offers a generous Total Rewards Plan for staff and eligible dependents. Comprehensive employee benefits package, including retirement and savings plan with generous company contributions, group medical, life and disability insurance. Discretionary annual bonus program. Exceptional learning, development and career advancement opportunities, empowering employees to grow and build long-term careers. At Amgen, we are committed to nurturing talent and providing meaningful pathways for professional development.
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