Head of Reagent Manufacturing and Science

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The Position

Purpose of the Role

To deliver consistently high-quality assay reagents across multiple sites, ensuring manufacturing readiness and scalability. This role is central to meeting company goals for rapid scale-up, continuous improvement, and the successful implementation of new manufacturing technologies and processes.

Key Responsibilities

• Develop and execute strategic capacity plans to ensure reagent supply meets the company’s aggressive scale-up and new product introduction timelines.
• Align reagent manufacturing performance with assay platform requirements, including stability, cost, and quality targets.
• Manage complexity across multiple concurrent projects, supporting global scale-up efforts as needed.
• Build a One Team ethos across R&D, scale-up, transfer, and manufacturing functions.

• Define clear reagent manufacturing requirements to enable successful R&D handover and process scalability.
• Implement robust validation strategies for all process changes, optimizations, and improvements—including equipment, processes, and test methods.
• Introduce automation and best-in-class equipment and processes to harmonize reagent manufacturing across sites.
• Drive continuous improvement initiatives to enhance batch-to-batch consistency and manufacturing efficiency.

• Ensure compliance with internal quality systems, GMP, GLP, GDP, and H&S protocols.
• Lead FMEA and risk mitigation strategies to safeguard product quality and personnel safety.
• Monitor and act on non-conformances, audit results, and documentation across reagent manufacturing operations.

• Foster strong partnerships with internal and external stakeholders, including suppliers and cross-functional teams.
• Communicate progress, challenges, and updates to all levels of the business in a proactive and transparent manner.
• Support knowledge transfer and cross-site standardization.

• Identify and address skill gaps within the reagent manufacturing teams, particularly in scale-up and technology transfer.
• Drive recruitment, coaching, and talent development to build high-performing, engaged teams.
• Collaborate with Training to implement impactful learning and development programs.
• Serve as a role model and mentor, fostering a culture of accountability, motivation, and collaboration.

• Manage departmental budget and monitor Reagents COGS, identifying and driving cost-saving opportunities.
• Leverage strategic supplier relationships and economies of scale to reduce costs and improve reagent quality.

Non-Technical Competencies

To be successful in this role, the candidate must demonstrate:

• A high level of motivation, flexibility, and a solutions-driven mindset.
• Strong technical and people leadership with the ability to operate at both strategic and tactical levels.
• Ownership, accountability, and drive to meet organizational goals.
• Clear and effective communication across functions and levels.
• Exceptional problem-solving skills in complex and ambiguous situations.
• Ability to work under pressure and meet critical deadlines.
• Willingness and ability to travel between company sites as needed.

• Proven leadership in reagent manufacturing, R&D transfer, and scale-up.
• Deep technical knowledge in reagent processes, including materials like antibodies, beads, and biological reagents.
• Strong understanding of GMP, validation, automation, and analytical technologies.
• Excellent organizational and project management skills.
• Experience building and leading high-performance teams across global locations.

Who we are

We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.