Process Development Manager

Amgen; Dublin; On-site; EUR 90,000 - 120,000; Full time

Job summary

Amgen in Ireland seeks a Process Development Manager who will deliver NPIs and lifecycle management for parenteral products. You will lead tech transfers and process validation with 5–10 years in pharma/biotech, and manage teams.

You will drive transfers into vial/syringe operations, support regulatory filings, CAPA, risk assessments, and collaborate with Manufacturing, QA and vendors to ensure compliant, robust processes for NPIs and post-NPI activities.

Qualifications

• Bachelor degree with 5 years’ experience in a similar role, or Master’s with 3 years, or Associate’s with 10 years.
• Knowledge of cGMP and global regulatory requirements.
• Strong problem solving, and excellent oral and written communication skills.

Responsibilities

• Lead new product introductions and lifecycle changes from a Process Development perspective.
• Manage a team of tech transfer engineers/scientists across vial/syringe transfers.
• Contribute to regulatory filings and respond to regulator questions as needed.
• Provide technical expertize for parenteral drug product processing and validation.
• Develop and transfer processes to commercial sites and support CAPA and risk assessments.
• Lead cross-site teams and collaborate with manufacturing, QA, and external vendors.

Skills

Leadership

Tech transfer

Process validation

Regulatory collaboration

Problem solving

Communication

Education

Bachelor's degree in Science, Engineering or related quality discipline

Master's degree in Science or Engineering (preferred)

PhD (preferred)

Job description

Overview

The Process Development Manager– will report to the Sr. Manager Process Development for New Product Introduction (NPI) Technical Delivery and will be responsible for technical delivery of NPIs and life cycle management (LCM) products to ADL. The successful candidate will have at least five to ten years of experience in a pharmaceutical or biotech industry and will have demonstrated competency in leading tech transfers and process validation activities as well as managing teams.

Job Scope

• Leads new product introductions and lifecycle changes into the vial and syringe plants from a Process Development perspective and then serves as the Process Development SME for these products following completion of the transfer.
• Manage a team of tech transfer engineers/scientists supporting other vial and syringe transfers to Dun Laoghaire.
• Be a key contributor to regulatory filings as part of the NPI process throughout the authoring, editing and submission process but also be responsible for response to regulator questions as and when required.
• Acts as a drug product manufacturing technical expert to provide solutions when troubleshooting drug substance freezing/thawing, formulation, filling vials/syringes/devices, lyophilization, inspection, and transportation for parenteral products through the NPI or post-NPI phases.
• Provide process development expertise for commercial drug product processing in specific areas such as sterile processing, process characterization, tech transfer and validation. Support commercial drug product manufacturing operations with technical evaluation of NC/CAPA and technology transfer. Interfaces with manufacturing as well as all support functions to provide robust and coordinated support to manufacturing.
• Develops and characterizes drug product processes and transfers technology to commercial drug product sites.
• Identifies and implements operational opportunities for current and new sterile operations.
• Troubleshoots issues with drug product processing technologies and equipment.
• Leads and conducts risk assessment for drug product operations and propose / implement appropriate CAPA.
• Responsibilities may include leading cross-site teams to support the above activities, providing recommendations to senior management. Provide support to the PD forensic lab and be a link to manufacturing on key investigations as a process expert.
• Development of validation plans, process performance qualifications (PPQs) for vial and syringe filling.
• Ensuring all aspects of activity within any given process validation adheres to required policies and procedures, including safety and training.
• Ensure that the site meets the quality requirements of its customers and applicable regulations (FDA, EU & international standards).
• Participate and lead in validation cross functional teams at the site to ensure adherence to required policies and procedures.
• Assist in the development of any existing validation program to ensure continued compliance to the necessary regulations.
• Input to site validation guidance documents.
• Collate and report on relevant shipping and filter validation.
• Pre-approve and post-approve process validation protocols and assessments from a quality system documentation perspective.
• Contribute to product quality assessments and process flow documents.
• Liaise with Operations, Engineering and external vendors regarding new or amended equipment which would impact the validated process.
• Lead or assist in deviation and exception resolution and root cause analysis.
• Participate as required in project activities and be developing own project management techniques.

Basic Qualifications

• A third level Bachelor’s degree in Science, Engineering or a relevant Quality discipline with 5 years’ experience in a similar role OR Master’s degree & 3 years of directly related experience OR Associate’s degree & 10 years of directly related experience
• Knowledge of cGMPs and other worldwide regulatory requirements.
• Problem solving ability and excellent oral and written communications skills

Preferred Qualifications

• PhD or Masters in Science or Engineering
• 5 + years of 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 Validation.
• Strong skills in applying fundamental engineering and scientific principles to the design, implementation and process validation of protein freeze-thawing, filtration, mixing, filling, and/or lyophilization processes. Knowledge of protein biochemistry regarding chemical and physical stability
• Project management skills including the ability to manage multiple projects and evaluate project resource requirements.
• Strong knowledge of Quality systems, Drug Product Manufacturing and Validation.
• Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion. Excellent Communication skill is essential for this role.

Amgen is an equal opportunities employer.