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- Tasks: Lead teams in shaping the future of biopharmaceutical manufacturing and drive operational excellence.
- Company: Join Sekisui Diagnostics, a leader in innovative diagnostics and biopharmaceutical solutions.
- Benefits: Competitive salary, comprehensive benefits, and opportunities for professional growth.
- Why this job: Make a real impact in the biopharmaceutical industry while leading high-performing teams.
- Qualifications: Proven leadership in regulated manufacturing and strong understanding of cGMP requirements.
- Other info: Diverse and inclusive workplace with a commitment to employee development.
The predicted salary is between 80000 - 100000 ÂŁ per year.
Are you ready to help shape the future of a growing biopharmaceutical site? Do you thrive on leading teams, driving operational excellence, and building strong technical capabilities? We are looking for an experienced technical and operational leader to join our Site Leadership Team. In this pivotal role, you will help define the future of our Maidstone, UK facility—positioning it as the partner of choice for pharmaceutical and biotechnology companies developing and producing proteins in microbial systems.
As Director, manufacturing (CDMO Operations), you will oversee all aspects of manufacturing strategy, site operations, and technical capability development. You will lead high‑performing teams, ensure high standards of quality and compliance, and play a key role in delivering customer programmes to cGMP standards. You will also act as the named Production Manager on our MIA(IMP) licence. This is a highly visible leadership role with influence across Production, Engineering & Maintenance, Process Development, Validation, Analytical Services, and cross‑functional business partners.
Key Responsibilities- Strategic Leadership
- Set and execute a clear strategic vision for your functions, ensuring alignment with site and corporate objectives.
- Drive future growth plans to strengthen our CDMO capabilities and technical expertise.
- Serve as a core member of the Senior Management Team (SMT).
- Operational Excellence
- Lead all aspects of Production to ensure products are manufactured and stored in accordance with approved documentation and quality standards.
- Approve production instructions, ensure strict execution, and oversee evaluation of production records prior to Quality review.
- Partner with Engineering, Maintenance and Validation to ensure facilities, equipment and utilities are compliant, well maintained, and fully validated.
- Oversee site assets to maximise utilisation and ensure on‑time delivery of high‑quality products to cGMP standards.
- Technical Leadership
- Provide direction and support to Process Development, Technology Transfer and Analytical Services to build the technical capability required for a successful CDMO business.
- Evaluate manufacturing methods and systems to support continuous improvement, operational efficiency and regulatory compliance.
- People Leadership
- Lead, mentor and develop department leaders and their teams, ensuring robust training, performance management, and career development across your functions.
- Quality & Compliance
- Drive continuous improvement to maintain and advance MHRA cGMP certification and compliance.
- Uphold Sekisui Diagnostics’ Quality Management System and ensure full alignment with MHRA, FDA, ISO and other regulatory standards.
- Act as the named Production Manager on the Manufacturer’s Authorisation for Investigational Medicinal Products (MIA(IMP)).
- Cross‑Functional Collaboration
- Foster strong collaboration with Sales, Operations, Finance, Supply Chain, external partners and vendors.
- Champion quality, productivity, cost‑saving and waste‑reduction initiatives across the site.
- Develop and implement vendor improvement programmes.
- Health, Safety & Environment
- Ensure a safe, healthy workplace for all employees, vendors and visitors.
- Contribute to our Environmental Management System (EMS) in alignment with ISO 14001.
What You Bring
- Proven experience leading technical and operational teams within a regulated manufacturing environment.
- Strong understanding of cGMP requirements and biopharmaceutical manufacturing processes.
- Demonstrated success in cross‑functional leadership, continuous improvement, and talent development.
- A collaborative, solution‑focused approach and the ability to influence at all levels.
Who We Are
At Sekisui Diagnostics, we help improve patient outcomes by focusing on innovating and developing highly accurate diagnostics tests, reagents and systems. In recent years, social and consumer needs for medical care have been diversifying in line with dramatic transformations in the global medical environment. We will continue to embrace change and challenge new frontiers so that we can create unique, high-quality products and services that will leave our customers truly satisfied. With worldwide state-of-the-art manufacturing facilities and an international sales and distribution network, we are a solid partner for healthcare professionals, distributors and manufacturers around the world. Our global capabilities allow us to meet the specific needs of our wide range of customers and customise solutions at both regional and product level.
Sekisui Diagnostics Offers a Competitive Compensation And Benefits Package.
Equal Opportunities
As an equal opportunity employer, Sekisui Diagnostics is committed to a diverse workforce. Employment decisions will be made without discrimination based on race, colour, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, other non-job-related characteristics or other prohibited grounds specified in applicable country and local laws. It is also Sekisui Diagnostics policy to comply with all applicable country and local laws respecting consideration of unemployment status in making hiring decisions.
Sekisui Diagnostics is pleased to consider all qualified applicants for open roles and encourages candidates to apply online. Only those candidates who are selected for further consideration or interviews will be contacted by a member of the company’s internal recruiting team.
Director Manufacturing (CDMO Operations) in Maidstone employer: Sekisui Diagnostics
Contact Detail:
Sekisui Diagnostics Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Director Manufacturing (CDMO Operations) in Maidstone
✨Tip Number 1
Network like a pro! Reach out to your connections in the biopharmaceutical industry and let them know you're on the lookout for opportunities. You never know who might have the inside scoop on a role that’s perfect for you.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. Understand their values and how they align with your own. This will help you showcase why you’re the ideal fit for the Director of Manufacturing role.
✨Tip Number 3
Practice your leadership stories! Be ready to share specific examples of how you've driven operational excellence and led teams in previous roles. This will demonstrate your capability to excel in a high-visibility position.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you’re genuinely interested in joining our team at Sekisui Diagnostics.
We think you need these skills to ace Director Manufacturing (CDMO Operations) in Maidstone
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter to highlight your experience in leading technical and operational teams. We want to see how your skills align with our mission at Sekisui Diagnostics!
Showcase Your Leadership Skills: In your application, emphasise your ability to lead high-performing teams and drive operational excellence. We’re looking for someone who can inspire and mentor others, so let that shine through!
Highlight Compliance Knowledge: Since this role involves ensuring compliance with cGMP standards, be sure to mention your understanding of regulatory requirements and any relevant experience you have in a regulated manufacturing environment.
Apply Through Our Website: We encourage you to submit your application directly through our website. It’s the best way for us to receive your details and get you into our recruitment process smoothly!
How to prepare for a job interview at Sekisui Diagnostics
✨Know Your Stuff
Make sure you have a solid understanding of cGMP requirements and biopharmaceutical manufacturing processes. Brush up on the latest trends in the industry, as well as the specific operations of the company you're interviewing with. This will show that you're not just interested in the role, but also invested in the company's mission.
✨Showcase Your Leadership Skills
Prepare examples of how you've successfully led teams in the past. Think about times when you drove operational excellence or mentored others. Be ready to discuss your approach to people leadership and how you foster collaboration across functions, as this is crucial for the Director role.
✨Align with Their Vision
Understand the strategic vision of the company and be prepared to discuss how you can contribute to it. Think about how your experience aligns with their goals for growth and technical capability development. This will demonstrate that you're not only a fit for the role but also a partner in their future success.
✨Ask Insightful Questions
Prepare thoughtful questions that reflect your interest in the role and the company. Inquire about their current challenges in manufacturing strategy or how they envision the future of their Maidstone facility. This shows that you're engaged and thinking critically about how you can add value.