Almac Group
Director of Formulation & Process Development
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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.
Ref No.: HRJOB11621
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
- 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 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.
- 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.
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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 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.
- Deep expertise in process validation in line with FDA Process Validation guidance (Stage 1–3) and ICH Q8/Q9/Q10.
- 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 initiative.
- Experience leading cross-functional teams across development, manufacturing and quality.
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Desirable criteria include:
- A postgraduate qualification in a relevant scientific discipline.
- Exposure to advanced formulation or drug delivery technologies.
- Experience contributing to business development activities and client proposals.
- Experience with global submissions (FDA, EMA, PMDA), particularly late-stage submissions and lifecycle management variations.
- Exposure to process control strategies.
Further Information
For further information on essential and desirable criteria, please review our candidate spec - Director – Formulation & Process Development - 1
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.
How To Apply
Apply online and tailor your CV to outline how you meet the role criteria. Please upload your CV in PDF format where possible.
Closing Date
We will no longer be accepting applications after 5pm on Sunday 26th July 2026.
RECRUITMENT AGENCIES PLEASE NOTE:
Almac will only accept applications from agencies/business partners that have been invited to work on this role by our Talent Acquisition team. Speculative candidate CVs received or submitted directly to Hiring Managers will be considered unsolicited and no fee will be payable. Thank you for your cooperation.
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