Director - Development

Location: Hours: 35 hours per week, Monday to Friday. Flexible working pattern.

Business Unit: Almac Pharma Services

Within Almac Pharma Services, our Formulation & Process Development teams are at the forefront of delivering innovative drug product solutions and supporting clients from early clinical development through to commercial manufacture. Due to continued growth, we are now seeking a Director of Formulation & Process Development to provide strategic and operational leadership across this critical function. This role represents a critical leadership position in enabling the successful transition of client programmes from development through to commercial manufacture, ensuring regulatory approval, inspection readiness, and sustained commercial performance.

In this role, you will lead high-performing scientific teams while working closely with cross-functional partners across Analytical, Manufacturing, and Quality, ensuring that all development and scale-up activities are phase-appropriate, inspection-ready, and aligned with FDA and global regulatory expectations. Acting as a senior scientific and strategic interface with clients, you will play a key role in shaping development pathways, advising on chemistry, manufacturing and controls (CMC) strategy, and ensuring robust control strategies and validated processes are established to support successful regulatory submissions and commercial manufacture.

Accountable for defining and delivering formulation and process development strategy aligned to business, client, and regulatory objectives:

• Ensuring alignment with FDA Process Validation Stage 1 (Process Design), including development of robust control strategies and risk-based approaches.
• Ensuring development outputs support regulatory submissions including development reports, validation documentation, and data packages suitable for NDA/BLA/MAA submissions and regulatory review.
• Ensuring readiness for PPQ execution (Stage 2) and successful transition to commercial manufacture.
• Ensuring robust lifecycle management post-approval including Continued Process Verification (CPV), ongoing process monitoring (Stage 3), change control governance, and data-driven continuous improvement.
• Ensuring complete, traceable technology transfer packages and reproducible manufacturing processes at commercial scale.
• Accountability for defining and delivering late-stage development strategies.
• Building and leading a high-performing, scalable organisation, setting a vision, capability development strategy, and succession planning.
• Driving a culture of compliance, accountability, and continuous improvement aligned with Almac's quality standards.
• Accountability for a complex, multi-product, multi-phase portfolio delivery across multiple client development and commercialisation programmes, ensuring alignment with business growth, revenue targets, and client and regulatory expectations.
• Partner with Business Development to shape proposals, define CMC strategy and development pathways, and secure new opportunities.
• Function as a senior representative during regulatory inspections and client audits, providing leadership in interactions with FDA and global health authorities.
• Ensure organisational readiness for pre-approval inspections (PAI) and commercial readiness reviews across programmes.
• Set and enforce standards for data integrity, validation governance, and inspection readiness across the function.
• Operate as a key member of the Pharma Services leadership team, influencing cross-functional decision-making across Manufacturing, Quality, Analytical, and Supply Chain.

We offer a supportive and collaborative working environment, with excellent opportunities for learning, development and long-term career progression across the Almac Group.

To succeed in this role, you will bring significant experience in pharmaceutical development, along with strong leadership capability and a deep understanding of formulation, process development and CMC strategy across the product lifecycle. A degree in Pharmacy, Chemistry, Pharmaceutical Sciences or a related discipline, or extensive equivalent experience.

Experience in pharmaceutical product development within a GMP-regulated environment, with a strong emphasis on late-stage development, Process Performance Qualification (PPQ), and commercialisation activities. Demonstrated record of progressing drug products from Phase III through process validation and into routine commercial manufacture, including scale-up, technology transfer and lifecycle management. Direct leadership of PPQ campaigns and successful commercial product launches, with accountability for delivery to regulatory and client expectations. Direct involvement in regulatory inspections and responses, ensuring inspection readiness and effective resolution of findings. Experience in technology transfer to commercial manufacturing sites, including execution of engineering and PPQ batches at commercial scale and development of robust tech transfer packages. Demonstrable ownership of lifecycle management post-approval, including the CPV programme, leadership, deviation trending, and implementation of continuous improvement initiatives. Experience leading cross-functional teams across development, manufacturing and quality. A postgraduate qualification in a relevant scientific discipline. Experience contributing to business development activities and client proposals.

This role reports to the Director of Operations Manufacturing and leads the Formulation Development function within Pharma Services. The role involves close collaboration with cross-functional teams and direct engagement with clients to support development programmes from early phase through to commercialisation.

Apply online and tailor your CV to outline how you meet the role criteria. We will no longer be accepting applications after 5pm on Sunday 26th July 2026.

Almac will only accept applications from agencies/business partners that have been invited to work on this role by our Talent Acquisition team.