Technical Operations Manager - Drug Product

Morgan McKinley; Sligo; On-site; EUR 90,000 - 120,000; Full time

Job summary

Morgan McKinley is seeking an experienced Technical Operations Manager for a leading global pharmaceutical manufacturer in Sligo. You will lead a small technical team, oversee process engineering, process chemistry, drug product manufacturing and new product introductions, with ownership of a portfolio of commercial products.

This senior role covers development, transfer, validation, optimization and manufacturing, with responsibility for budgets and cross-functional project delivery.

Qualifications

• Requires degree in Science, Chemistry or Chemical Engineering.
• 4+ years' experience in process chemistry or process engineering within a GMP pharmaceutical environment.
• Previous people-management experience with direct reports.
• Approximately 3+ years' experience supporting new product introductions and/or pharmaceutical start-ups.

Responsibilities

• Leading and developing a team of process engineers and process chemistry professionals.
• Providing technical leadership across drug product and solid oral dose manufacturing processes.
• Leading new process and validation activities from project start-up through to process qualification.
• Planning and leading technical transfers and new product introductions.
• Supporting batch processing, commissioning and validation activities.
• Leading troubleshooting and providing technical support for complex manufacturing issues.
• Identifying and delivering continuous improvement projects across yield, cycle time, process performance and cost.
• Preparing feasibility studies, process fits and development plans for future products.
• Managing medium-scale capital projects.
• Supporting departmental budgets and future manufacturing requirements.
• Working with cross-functional teams and internal and external stakeholders to support product development and transfer.
• Contributing to longer-term technical and manufacturing strategy for the site.

Skills

Leadership

Process engineering

GMP compliance

Technical leadership

Decision making

Education

BSc in Chemistry or Chemical Engineering

Job description

An exciting opportunity has arisen for an experienced Technical Manager to join a leading global pharmaceutical organisation at its established manufacturing operation in Sligo.

This is a senior technical leadership position combining people management, process engineering/process chemistry, drug product manufacturing and new product introduction. This is an excellent opportunity for someone who wants to take on a senior technical leadership role within a large, well-established pharmaceutical manufacturing environment. You will lead an experienced technical team and have responsibility for supporting a portfolio of established commercial products as well as bringing new products and processes onto site.

The role offers significant technical ownership and autonomy. You'll be involved in everything from process development and technical transfer through to validation, process optimisation and commercial manufacturing.

For someone who enjoys both the technical and leadership side of pharmaceutical manufacturing, this is a role where you can have a real influence on how products are introduced, manufactured and continuously improved.

The Role

As Technical Operations Manager, you will lead a team of approximately 3-6 technical professionals, with responsibility for their development, performance and technical direction.

You will have technical accountability for approximately 4-6 commercial and new products, supporting large-scale drug product manufacturing and future product introductions.

Responsibilities

• Leading and developing a team of process engineers and process chemistry professionals.
• Providing technical leadership across complex drug product and solid oral dose manufacturing processes.
• Leading new process and validation activities from project start-up through to process qualification.
• Planning and leading technical transfers and new product introductions.
• Supporting batch processing, commissioning and validation activities.
• Leading troubleshooting and providing technical support for complex manufacturing issues.
• Identifying and delivering continuous improvement projects across yield, cycle time, process performance and cost.
• Preparing feasibility studies, process fits and development plans for future products.
• Managing medium-scale capital projects.
• Supporting departmental budgets and future manufacturing requirements.
• Working with cross-functional teams and internal and external stakeholders to support product development and transfer.
• Contributing to longer-term technical and manufacturing strategy for the site.

Requirements

• A degree in Science, Chemistry, Chemical Engineering, Process Engineering or another relevant technical discipline.
• 4+ years' experience in process chemistry or process engineering within a GMP pharmaceutical environment.
• Previous people-management experience, including managing direct reports.
• Approximately 3+ years' experience supporting new product introductions and/or pharmaceutical start-ups.
• Strong experience in batch processing, technical transfer, commissioning and validation.
• Experience supporting complex pharmaceutical manufacturing processes.
• Strong technical problem-solving skills and the ability to make decisions in a fast-paced manufacturing environment.
• A strong GMP, compliance and safety mindset.

This would suit an experienced Technical Manager, Process Engineering Manager, Process Chemistry Manager, Technical Operations Manager or Senior Technical Lead who is ready to take ownership of both a team and a portfolio of important pharmaceutical products.