Head of Sterile Manufacturing
Are you a skilled leader in sterile GMP manufacturing, ready to take your career to the next level? This is an exciting opportunity to join a dynamic and rapidly growing CDMO at the forefront of pharmaceutical development and manufacturing.
The Company
My client specialises in developing and manufacturing pharmaceutical products, covering a range of formulations. With significant investment into a new facilities, the business is undergoing an ambitious expansion.
By joining the team, you’ll step into a positive, forward-thinking culture in a state-of-the-art facility that delivers innovative medicines to patients worldwide.
The Role
As Head of Sterile Manufacturing, you will shape and lead sterile GMP manufacturing operations. This includes process development, clinical batch manufacturing, technical transfers, and process scale-up activities. Building a team of operational staff, you will be responsible for operational activities within a cutting-edge sterile manufacturing facility.
You’ll ensure compliance with regulatory requirements, develop robust processes, and work closely with clients and internal teams to deliver high-quality outcomes.
Key Responsibilities
*Oversee all sterile GMP manufacturing operations, ensuring compliance with EU GMP Annex 1 and internal quality systems.
*Lead the development, qualification, and validation of sterile manufacturing processes and equipment.
*Manage the sterile GMP facility, including environmental controls, process validation, and documentation.
*Provide leadership to the manufacturing team, ensuring their performance, training, and development.
*Drive technical transfer and process scale-up activities for both in-house and outsourced projects.
*Serve as the key representative during client visits, audits, and regulatory inspections.
*Collaborate with cross-functional teams, including Project Management and Finance, to ensure commercial targets are met.
*Monitor budgets and deliverables, ensuring projects are completed to the highest standard.
About You
*Leadership: Proven track record of leading and developing high-performing teams.
*Experience: Demonstrable expertise in sterile GMP manufacturing and knowledge of EU GMP Annex 1 requirements. Practical knowledge of isolators
*Skills: Strong relationship management, communication, and problem-solving abilities.
*Qualifications: Degree-level education in a relevant scientific, engineering, or manufacturing discipline.
This is a rare opportunity to join a company at an exciting stage of growth. If you’re ready to lead a world-class sterile manufacturing team and make a real impact in pharmaceutical development, apply today!
If you’re interested in the above role then please click apply or get in touch to discuss further.
Consult will endeavour to contact candidates within 14 days of application. However, if you do not hear back after 2 weeks then please assume on this occasion, unfortunately, you have not been successful.