Job Type: Perm
Job ID: JO-1908-19244
Consultant: Karen McHugh
Do you have significant experience in support of Commercial Protein Drug Product (DP) processing?
Would you like to work for a company who provides an outstanding work environment and opportunities for career development?
If you have the relevant experience, please forward your CV to firstname.lastname@example.org for review or call 353 1 7978720 to discuss in confidence.
Lead Engineer - Drug Product Process Development - Dun Laoghaire - Dublin
Our Client and the role will be based in their Dun Laoghaire plant.
The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.
Reporting to the Director of Drug Product Process Development, this role will be based out of Amgen Dun Laoghaire, as part of the global Process Development (PD) organization. This role will require the candidate to lead a team which supports manufacturing at various drug product contract manufacturing sites around Europe. The team supports new product introductions, lifecycle changes and ongoing commercial and clinical production and development.
The team supports a broad range of product formats (cartridges, syringes, freeze dried and liquid vials) and a broad range of product types (including monoclonal antibodies, therapeutic proteins, small molecules and more novel modalities) across multiple sites.
International travel will be required to visit contract manufacturing partner sites in Europe. The successful candidate will:
Provide technical and management leadership to a cross functional team of engineers and scientists for all processing stages from drug substance thawing, formulation, filling, lyophilization and visual inspection unit operations.
Act as a drug product technical expert, to provide leadership and solutions when troubleshooting parenteral drug product manufacturing, for all processing stages from drug substance thawing, formulation, filling, lyophilisation, inspection, and transportation of vials, syringes and devices, for parenteral products through the new product introduction (NPI) or post-NPI phases.
Act as the accountable point contact from PD organization for product/process support for technology transfers and ongoing clinical and commercial drug product manufacturing at assigned contract manufacturing sites.
Build excellent business relationships with contract manufacturing partners, Global Operations, Contract Manufacturing Quality, and drug product process teams.
Lead functional and cross functional teams by setting the agenda, identifying issues and driving to goal completions and target dates.
Troubleshoot issues with drug product processing technologies and equipment.
Escalate issues, recommendations, and/or unresolved decisions in a professional and timely manner to the appropriate governance.
Holds others responsible or answerable for their actions, for exemplary job performance, and achieving business results.
BSc or BE Degree educated with significant relevant experience in contract manufacturing of parenteral dosage forms
Strong leadership skills with significant managerial experience directly managing people, teams, projects and programs
Preferred Qualifications and Experience:
Masters or PhD in Science or Engineering.
Significant experience in support of Commercial Protein Drug Product (DP) processing in specific areas such as Sterile Processing, Process Characterization, Tech Transfer (to commercial DP sites) or Process Validation.
Strong skills in applying fundamental engineering and scientific principles to the design, implementation and process validation of protein freeze-thawing, filtration, mixing, filling, lyophilisation and/or inspection processes.
Knowledge of development of commercial processes and process characterization.
Knowledge of protein biochemistry with regard to chemical and physical stability.
Project management skills including the ability to manage multiple projects and evaluate project resource requirements.
Ability to lead effectively in a highly matrixed organization.
Strong knowledge of quality and regulatory systems, drug product manufacturing and process validation.
Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion.
Full clean driving licence to facilitate travel.
Health plan for self & dependents
excellent pension plan
Annual performance related bonus
28 days annual leave
Karen McHugh is the consultant managing this position.
If you have any queries about this role, you can contact him by e-mail email@example.com or phone +353-1-7978720
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