Almac Group
Director of Formulation & Process Development
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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.
Ref No.: HRJOB11621
About the Role
Within Almac Pharma Services, our Formulation & Process Development teams are at the forefront of delivering innovative drug product solutions, 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 for enabling the successful transition of client programmes from development through to commercial manufacture.
In this role, you will:
- Lead high-performing scientific teams.
- Work closely with cross-functional partners across Analytical, Manufacturing, and Quality.
- Ensure all development and scale-up activities are phase-appropriate, inspection-ready, and aligned with FDA and global regulatory expectations.
- Act as a senior scientific and strategic interface with clients, shaping development pathways, advising on CMC strategy, and ensuring robust control strategies and validated processes for successful regulatory submissions and commercial manufacture.
Responsibilities
Key responsibilities include:
- Accountability 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, and MAA submissions.
- 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 team, 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 multi-product, multi-phase portfolio delivery aligned with business growth, revenue targets, and client/regulatory expectations.
- Partnership with Business Development to shape proposals, define CMC strategy and development pathways, and secure new opportunities.
- Influencing investment decisions relating to capabilities, technologies, and capacity expansion.
- Serving as a senior representative during regulatory inspections and client audits, providing leadership in interactions with FDA and global health authorities.
- Ensuring organisational readiness for pre-approval inspections (PAI) and commercial readiness reviews across programmes.
- Setting and enforcing standards for data integrity, validation governance, and inspection readiness.
- Operating 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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Benefits
Joining Almac Pharma Services means becoming part of a fast-paced, growing organisation within a highly regulated industry, offering:
- A supportive and collaborative working environment.
- Excellent opportunities for learning, development, and long-term career progression.
- A culture that supports, develops, and rewards talent, advancing human health.
More information can be found here: Life at Almac.
Success Criteria
To succeed in this role, you will bring significant experience in pharmaceutical development, alongside strong leadership capability, a deep understanding of formulation, process development, and CMC strategy, and the confidence to operate at a senior level, influencing stakeholders, clients, and leading complex programmes within a regulated environment.
We are particularly interested in candidates who have:
Essential
- A degree in Pharmacy, Chemistry, Pharmaceutical Sciences, or related discipline, or equivalent extensive experience.
- Proven experience in pharmaceutical product development within a GMP-regulated environment, with emphasis on late-stage development, PPQ, and commercialisation activities.
- Demonstrated record of progressing drug products from Phase III through process validation and commercial manufacture, including scale-up, technology transfer, and lifecycle management.
- Deep expertise in process validation aligned with FDA Process Validation guidance (Stages 1–3) and ICH Q8/Q9/Q10.
- Direct leadership of PPQ campaigns and commercial product launches, accountable for 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 engineering and PPQ batches at commercial scale and development of robust tech transfer packages.
- Ownership of lifecycle management post-approval, including CPV programmes, deviation trending, and implementation of continuous improvement initiatives.
- Experience leading cross-functional teams across development, manufacturing, and quality.
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Desirable
- Postgraduate qualification in a relevant scientific discipline.
- Exposure to advanced formulation or drug delivery technologies.
- Contribution to business development activities and client proposals.
- Experience with global submissions (EMA/FDA/PMDA), particularly late-stage submissions and lifecycle management variations.
- Exposure to process control strategies.
Additional Information
Further information on candidate specifications can be reviewed here Director – Formulation & Process Development - 1.
This role reports to the Director of Operations – Manufacturing and leads the Formulation Development function within Pharma Services. Successful candidates will have close collaboration with cross-functional teams and direct client engagement from early phase through to commercialisation.
Application Process
Apply online and customize your CV to outline how you meet these criteria, preferably in PDF format.
Closing Date
Applications will no longer be accepted after 5:00 PM 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 the Talent Acquisition team.
- Unsolicited candidate CVs will be disregarded, and no fees will be paid. Thank you for your cooperation.
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