Senior Manager, Process Development, External Process Engineering

Senior Manager Process Development External Process Engineering

Amgen Dun Laoghaire (ADL)

Live

What you will do

Lets do this. Lets 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 Chain and 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 .

• 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 Transfer or Validation.

• BSc in science engineering or equivalent with additionally qualifications (Masters /PhD).

• Masters 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.

• 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 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