Director, CDMO Manufacturing Operations in Maidstone

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.

About the Role

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.
  • 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. 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.

Sekisui Diagnostics offers a competitive compensation and benefits package. 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.