At a Glance
- Tasks: Lead teams in developing innovative drug products and ensure regulatory compliance.
- Company: Almac Pharma Services, a leader in pharmaceutical development.
- Benefits: Flexible working hours, competitive salary, and opportunities for professional growth.
- Other info: Join a dynamic team focused on innovation and collaboration.
- Why this job: Make a real impact in healthcare by guiding drug development from concept to patient.
- Qualifications: Proven leadership in formulation and process development with regulatory expertise.
The predicted salary is between 80000 - 100000 £ per year.
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 include:
- 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.
StudySmarter Expert Advice🤫
We think this is how you could land Director of Formulation & Process Development in London
✨Unlock Networking Opportunities
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Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like Almac Group (Uk) Ltd.
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If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Almac Group (Uk) Ltd. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
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We think you need these skills to ace Director of Formulation & Process Development in London
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 Almac Group (Uk) Ltd!
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 Almac Group (Uk) Ltd 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 Almac Group (Uk) Ltd!
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 Almac Group (Uk) Ltd, 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 Almac Group (Uk) Ltd
✨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 Almac Group (Uk) Ltd 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 Almac Group (Uk) Ltd’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.
