At a Glance
- Tasks: Lead formulation and process development strategies for innovative pharmaceutical products.
- Company: Join a leading pharmaceutical contract development organisation in Northern Ireland.
- Benefits: Shape drug development strategies and work with global clients in a dynamic environment.
- Other info: Excellent long-term career development opportunities in a supportive, innovative culture.
- Why this job: Make a significant impact on the future of pharmaceutical innovations and client success.
- Qualifications: Degree in Pharmacy or related field; leadership experience in pharmaceutical development required.
The predicted salary is between 85500 - 104500 £ per year.
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.
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.
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.\"
Director – Formulation & Process Development in Newcastle upon Tyne employer: Hyper Recruitment Solutions
As a leading life sciences organisation based in London, we pride ourselves on fostering a dynamic and innovative work environment that empowers our employees to drive meaningful change in scientific operations. Our hybrid work model promotes a healthy work-life balance while providing ample opportunities for professional growth through hands-on project leadership and collaboration with senior leadership and cross-functional teams. Join us to be part of a culture that values continuous improvement and the pursuit of excellence in laboratory systems and operational infrastructure.
Contact Details:
Hyper Recruitment Solutions Recruitment Team
StudySmarter Expert Advice🤫
We think this is how you could land Director – Formulation & Process Development in Newcastle upon Tyne
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We think you need these skills to ace Director – Formulation & Process Development in Newcastle upon Tyne
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Hyper Recruitment Solutions!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Hyper Recruitment Solutions that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Hyper Recruitment Solutions!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Hyper Recruitment Solutions, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Hyper Recruitment Solutions
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Hyper Recruitment Solutions that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Hyper Recruitment Solutions’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
