Locate Bio is a leading regenerative medicine company focused on developing class leading bone graft substitutes for spine and orthopaedic surgeons.
We are currently looking to appoint a talented and motivated Head of Operations to oversee the manufacturing operations at our Nottingham, UK GMP facility. Of particular focus will be the manufacturing operations of our combination product containing recombinant human bone morphogenetic protein-2 (rhBMP-2), currently in human clinical trials. The successful candidate will be responsible for ensuring efficient, high-quality production while driving process improvements, optimising packaging solutions, managing supplier relationships, and leading design transfers from R&D to full-scale manufacturing—both internally and with external contract manufacturers.
The role requires an individual who has the drive, enthusiasm, and motivation to support the ongoing development of an exciting, dynamic, and growing business.
This is a strategic and hands-on role requiring deep expertise in medical device manufacturing, regulatory compliance (ISO 13485, FDA, MDR), process optimisation, and cross-functional collaboration.
Key Responsibilities
Manufacturing Oversight & Process Improvement
1. Oversee daily manufacturing operations, ensuring compliance with ISO 13485, FDA 21 CFR Part 820, MDR, and GMP regulations.
2. Identify and implement process improvements to enhance efficiency, reduce costs, and maintain the highest quality standards.
3. Work closely with the Quality and Regulatory teams to ensure all production activities align with regulatory requirements.
4. Ensure robust CAPA and risk management processes are in place and continuously improved.
5. Support scale-up activities, ensuring seamless expansion of production capacity as needed.
Packaging & Supplier Management
1. Optimize packaging solutions to improve product integrity, sterility, and cost-effectiveness while maintaining regulatory compliance.
2. Collaborate with packaging engineers and external suppliers to develop and validate new packaging materials and configurations.
3. Manage key supplier relationships, ensuring consistent quality, reliability, and cost efficiency.
4. Work closely with the quality team to mitigate risks and improve vendor performance.
Design Transfer & Cross-functional Collaboration
1. Lead the design transfer process for new products from R&D to manufacturing, ensuring seamless transition and manufacturability.
2. Support process validation (IQ/OQ/PQ) strategies for new product introductions, and product changes.
3. Collaborate with internal teams and external contract manufacturers (CMOs) to ensure manufacturing readiness and continuous product availability for clinical studies.
4. Work closely with R&D, Quality, and Regulatory Affairs to ensure alignment between design, manufacturing, and compliance requirements.
Leadership & Strategic Initiatives
1. Provide technical leadership and mentorship to manufacturing teams, fostering a culture of continuous improvement.
2. Drive Lean Manufacturing, Six Sigma, and operational excellence initiatives to enhance overall efficiency.
3. Develop and track KPIs for manufacturing performance, quality, cost, and process improvements.
4. Support regulatory inspections and audits related to manufacturing processes.
Required Skills and/or Qualifications
1. Bachelor’s or master’s level qualification in Engineering, Manufacturing, Biomedical Engineering, or a related field. Or equivalent experience.
2. Significant experience in a senior operations role within medical device manufacturing.
3. Strong expertise in Class III medical devices and their regulatory landscape (ISO 13485, FDA 21 CFR 820, MDR, GMP).
4. Proven experience in process optimization, packaging solutions, and supplier management.
5. Hands-on experience with design transfer, validation (IQ/OQ/PQ), and working with external contract manufacturers.
6. Strong understanding of Lean Manufacturing, Six Sigma, and Continuous Improvement methodologies.
7. Excellent leadership, problem-solving, and project management skills.
8. Strong interpersonal and communication skills for cross-functional collaboration.
9. Experience working in a fast-paced, high-growth medical device company.
Why Join Us?
1. Impactful work: Be at the forefront of delivering life-changing medical devices.
2. Career growth: Opportunity to influence and shape manufacturing strategy.
3. Collaborative environment: Work with cross-functional teams dedicated to innovation and excellence.
4. Competitive benefits: Attractive salary and benefits package.
If you would like to apply for this position, please email your CV and covering letter to Victoria Oldham – HR Manager at voldham@locatebio.com
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