Director of Formulation & Process Development

Director of Formulation & Process Development

Location:

Craigavon, Northern Ireland

Hours:

35 hours per week, Monday Friday. Flexible working pattern. Business Unit:
Almac Pharma Services Open To:
Internal and external applicants welcome to apply. .: HRJOB
11621 The Opportunity 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. Working in a highly collaborative and regulated environment, we play a key role in enabling medicines to progress efficiently from concept to patient. 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.

Key responsibilities include:

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 lead 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 Almacs 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. Influence investment decisions related to capabilities, technologies, and capacity expansion. 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. Joining Almac means becoming part of a fast-paced, growing organisation within a highly regulated industry. We offer a supportive and collaborative working environment, with excellent opportunities for learning, development and long-term career progression across the Almac Group.

Our approach is simple we support, develop and reward our people, build fulfilling careers and together we advance human health. More information can be found here; s Not Allowed] What you need to be successful 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.

You will be confident operating at a senior level, influencing stakeholders and clients, and leading complex programmes within a regulated environment. We are particularly interested in hearing from candidates who have: A…