Hyper Recruitment Solutions
Director – Formulation & Process Development
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ROLE OVERVIEW
We are currently looking for a Director of Formulation & Process Development to join a leading pharmaceutical contract development and manufacturing organisation based in Northern Ireland. This is an exciting opportunity for an experienced technical leader with a strong background in formulation development, CMC strategy, and drug product commercialisation to play a key role in shaping the future of pharmaceutical development programmes.
As Director of Formulation & Process Development, you will provide both strategic and operational leadership across formulation and process development activities, supporting projects from first-in-human clinical studies through to commercial manufacture.
You will act as a senior scientific expert, working closely with clients and cross-functional teams to deliver innovative, compliant, and commercially viable drug product solutions. This position offers the opportunity to influence development strategy across multiple programmes while leading a talented scientific team in a dynamic and client-focused environment.
KEY DUTIES AND RESPONSIBILITIES
Your duties as the Director of Formulation & Process Development will be varied; however, the key duties and responsibilities are as follows:
- Lead the development and execution of formulation and process development strategies across the entire drug product lifecycle, from early clinical development through to registration and commercialisation.
- Provide strategic leadership and technical direction across Formulation Development, Analytical Support, Manufacturing Science & Technology, Manufacturing, and Quality functions.
- Act as the senior CMC subject matter expert, advising clients on development pathways, regulatory expectations, technical risks, and commercial readiness.
- Oversee technology transfer, process scale-up, process validation (PPQ), and preparation for commercial manufacturing activities.
- Ensure all formulation development activities, technical documentation, development reports, and regulatory submission content are aligned with global regulatory standards and expectations.
- Build, develop, and lead a high-performing scientific team through effective recruitment, coaching, succession planning, and capability development.
- Drive continuous improvement initiatives, establish key performance indicators, and ensure efficient delivery against quality, cost, and timeline objectives.
- Support business development activities through technical leadership during client meetings, proposals, and strategic discussions, helping strengthen long-term customer partnerships.
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ROLE REQUIREMENTS
To be successful in your application to this exciting role as Director of Formulation & Process Development, we are looking to identify the following on your profile and past history:
- Degree qualified in Pharmacy, Chemistry, Pharmaceutical Sciences, or a related scientific discipline. An MSc or PhD would be advantageous.
- Extensive leadership experience within pharmaceutical formulation and process development in a GMP-regulated environment.
- Demonstrated expertise across the full drug product lifecycle, including early development, commercialisation, lifecycle management, and product optimisation.
- Strong experience developing and implementing CMC strategies supporting global regulatory submissions, including IND, CTA, NDA, and MAA applications.
- Deep understanding of formulation development, process scale-up, technology transfer, process validation, and commercial readiness activities.
- In-depth knowledge of FDA, EMA, ICH, and cGMP requirements.
- Proven ability to lead multidisciplinary teams and successfully manage multiple development programmes in a client-facing environment.
- Experience within a CDMO/CMO environment and exposure to regulatory inspections would be highly advantageous.
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WHAT'S IN IT FOR YOU?
This is an outstanding opportunity to join a highly respected pharmaceutical organisation at a senior leadership level. You will have the opportunity to shape development strategy across a diverse portfolio of pharmaceutical products, work directly with global clients, influence major technical decisions, and contribute to the successful progression of innovative medicines from development through to commercial launch.
You will join an organisation committed to scientific excellence, innovation, and investing in both people and technology, offering excellent long-term career development and the opportunity to make a significant impact on business and client success.
Key Words: Formulation Development / Process Development / CMC Strategy / Drug Product Development / Technology Transfer / Scale-Up / PPQ / Commercialisation / cGMP / ICH / FDA / EMA / Pharmaceutical Development / Leadership / CDMO / Clinical Supply / Regulatory Submissions / Lifecycle Management
"Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career."
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