Director of Formulation & Process Development TLNT1_NI

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 13) 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 initiatives.
• Experience leading cross-functional teams across development, manufacturing and quality.

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.

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.

Skills: Validation, Process Development, Formulation development, GMP Compliance, Pharmaceutical Drug Products, Process Validation, Technology Transfer

Benefits: Flexible Schedules, Professional Coaching, Opportunities for Advancement, Work/Life Balance, Wellness Programs, Group Healthcare Scheme