Head of Technical Operations (IMMULITE)
This role reports directly to the Managing Director & Head, IMMULITE Manufacturing Center of COE and is part of the Llanberis site leadership team. You will lead and manage all aspects of technical operations related to the IMMULITE reagents, ensuring the highest standards of quality, efficiency, and compliance.
Responsibilities
* Develop and execute the Technical Operations strategy for IMMULITE, aligning with business goals to deliver on supply, quality and cost/productivity targets.
* Oversee technical support for IMMULITE raw material and reagent manufacturing, including troubleshooting, process optimization, and supply resilience.
* Ensure robust root cause analysis and corrective actions for technical issues.
* Build and lead a high‑performing Technical Operations team, fostering a culture of excellence, innovation, and accountability.
* Develop an HLA strategy to optimize manufacturing costs for the IMMULITE, VersaCell and spares products.
* Ensure all Technical Operations staff comply with relevant regulatory standards (e.g., ISO 13485, FDA, MHRA) and support internal and external audits, inspections and regulatory submissions.
* Lead and support technical projects, including material change, product improvements and new product introductions, managing costs, timelines and stakeholder communications.
* Work closely with Manufacturing, Quality, R&D, Supply Chain and other departments, acting as a key technical liaison for internal and external stakeholders.
* Manage departmental budgets and resource allocation, ensuring efficient operations while maintaining high standards of quality and delivery.
* Ensure engagement of the team in all aspects of Environmental, Health and Safety to support a positive, proactive EHS culture.
Qualifications & Experience
* Bachelor’s or Master’s degree in Life Sciences or related field (PhD preferred).
* Proven experience (10+ years) in technical support within diagnostics manufacturing.
* Strong leadership experience managing multidisciplinary teams.
* Deep understanding of immunoassay platforms, particularly IMMULITE, is highly desirable.
* Excellent problem‑solving, communication and project management skills.
* Experience with Lean, Six Sigma or other continuous improvement methodologies.
* Proven leadership in GMP manufacturing environments, including biologics and in‑vitro diagnostics.
* Strong understanding of regulatory frameworks (e.g., ICH, FDA, EMA) and quality systems.
* Experience with technology transfer, process/product validation.
* Ability to manage complex projects with a strategic mindset, critical thinking and willingness to challenge the status quo.
* Demonstrated cross‑functional change‑ and stakeholder‑management skills, organizational management and strong communication skills at all levels of the organization.
* Fluency in data analysis, predictive analytics, data insights and exposure to AI/ML.
* Clear thinker who can cut complexities coupled with a sense of pragmatism, strong interpersonal, verbal and written communication.
Benefits
* 26 days’ holiday with the option to buy or sell an additional 5.
* Up to 10% employer pension contribution.
* Share and bonus scheme.
* Access to flexible benefits from private medical insurance to dental cover.
* Corporate Social Responsibility opportunities, including 2 paid volunteering days per year and support from a 24/7 employee assistance programme.
As an equal opportunity employer, we welcome applications from individuals with disabilities.
#J-18808-Ljbffr