Senior Manager, Process Development, External Process Engineering

Job description

Senior Manager – Process Development, External Process Engineering

Amgen Dun Laoghaire (ADL) |

**Live**  

**What you will do**  

Let’s do this.

Let’s change the world.

Amgen is a global leader in biotechnology, dedicated to discovering, developing, and delivering innovative human therapeutics.

Since 1980, Amgen has pioneered new science and delivered safe, effective medicines to patients worldwide, transforming the practice of medicine and improving millions of lives.

The company is committed to advancing science and helping patients, fostering a culture that supports staff growth, collaboration, and excellence.

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** **:**

+ Team Leadership: Lead, mentor, and develop a team of engineers and scientists, ensuring high-quality support for internal and external stakeholders.

Set agendas, identify issues, and drive goal completion and target dates.

+ Technical and Management Leadership: Provide expertise across all stages of drug product manufacturing, including formulation, filling, lyophilisation, visual inspection, and transportation of vials, syringes, and cartridges.

+ Support for Contract Manufacturers: Act as the principal contact for process development and product support at contract manufacturing sites, ensuring effective technology transfers and ongoing commercial and clinical manufacturing.

Build and maintain strong business relationships with contract manufacturing partners, ACDM, External Supply Quality, Supply Chainand other relevant teams.

+ Process Development: Drive process optimisation and continuous improvement initiatives, implement new technologies, and support new product introductions and lifecycle management.

Ensure robust process monitoring and validation for assigned processes.

+ Troubleshooting and Technical Solutions: Providing leadership and solutions for troubleshooting manufacturing processes and equipment across all unit operations.

+ 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.

+ Escalation Procedures: Escalate issues, recommendations, and unresolved decisions in a timely and professional manner to appropriate governance.

Ensure all relevant groups are represented in decision-making processes.

+ Collaboration and Communication: Foster strong collaboration across functions and sites, actively communicate with internal and external partners, and influence executive management as required.

+ 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.

**Win**

**What we expect of you**  

The successful candidate for this role will bring the following education, skills and experience 

Basic Qualifications:

+ 10 + years of experience in support of Commercial Protein Drug Product (DP) processing in specific areas such as Sterile Processing, Process Characterisation, Tech Transferor 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 Europearerequired tofacilitate 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.

+ Technical expertise in parenteral drug product manufacturing processes.

+ Strong problem-solving and analytical skills.

+ Excellent communication and collaboration skills, with the ability to influence at all organisational levels.

+ Solid understanding of regulatory and quality systems.

+ Ability to operate effectively in a highly matrixed organisation.

+ Capacity to learn, adapt, and act on dynamic information rapidly.

Travel and Work Arrangements:

This position is based at Amgen Dun Laoghaire, with flex worker arrangements available.

International travel is required to contract manufacturing partner sites across Europe to support key production milestones and build relationships.

Moderate travel (up to 15%) may be expected.

**Thrive**

**What you can expect of us **  

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.



_Amgen is an equal opportunities employer_

Required Skill Profession

Other General