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Head of Manufacturing Operations

7 months ago

Bedford, United Kingdom Mologic TA Global Access Diagnostics Full time

_GADx is a diagnostics company with the vision to improve global health by access to innovative diagnostics and therapeutics for all. We are passionate about global health and innovations to achieve this._
- We are now looking to recruit a full-time Head of Manufacturing Operations. The position will report to our CEO. The Head of Manufacturing Operations will be a key member of the Senior Leadership Team, responsible for shaping and guiding the strategic direction within the GADx products and services portfolio. _
- This role is crucial in promoting revenue generation in alignment with both the company's and group's objectives. It requires engagement with both external and internal stakeholders to ensure a consistent progression of projects and products during the development stages. The role will also be involved in the wider strategic planning and implementation processes of the company._

**Key deliverables**:

- Be responsible for Tech Transfer/Manufacturing, ensuring full compliance with customer and regulatory requirements.
- Define and implement manufacturing structure and processes.
- Manage the budget for your department.
- Monitor performance to proactively identify efficiency or process issues and propose solutions.
- Maintain a working knowledge of all phases of operations and coordinate support throughout the business.
- Structure and develop a motivated and engaged team through hands-on leadership, identifying training needs and managing performance.
- Actively interact with potential and current clients, 3rd party suppliers, Key Opinion Leaders (KOLs) and other vital stakeholders. This encompasses a wide range of entities including scientific, engineering, medical teams, external technical development collaborators, regulatory bodies, statisticians, clinical teams, quality assurance, commercial associates, and more. Facilitating communication between multidisciplinary teams including development, manufacturing, regulatory, quality and clients etc, to enable efficient collaborative working and product progression and delivery.
- Actively identify and present propositions for next-generation products or potential extensions. This requires maintaining consistent dialogue with clients, achieved through both in-person and virtual interactions.
- This role involves staying abreast of industry trends and providing directional guidance for projects, streamlining progress and decision-making.
- Adhere rigorously to GADx's Quality Management System (QMS) and Health & Safety Policy. This encompasses upholding ethical research principles, observing conditions related to human tissue sample storage under GADx's HTA Licence, and ensuring licensing compliance for animal and crop pathogens. Oversee the team's timely and accurate documentation processes, including lab books, SOPs, design control documentation and other quality-centric documents. Maintain unwavering diligence towards safety protocols, such as COSHH and risk assessments & Biosafety.

**Technical skills and competencies**:

- Demonstrate comprehensive experience in managing minor and major projects/programs, encompassing budget formulation, detailed planning, resource allocation, tracking, and technical delivery.
- Possess expertise in ISO 13485 Manufacturing and Technology Transfer. Ensure consistent alignment with internal quality and regulatory benchmarks.
- Expertise in Good Manufacturing Practice approaches as suitable for IVDs.
- Experience in the development of lateral flow point of care rapid diagnostics, novel diagnostic platforms and approaches including new technology and IP.
- Demonstrate the ability to effectively plan, structure, and draft proposals and reports. Showcase competency in delivering impactful presentations.
- Understand market and customer needs, market dynamics and be able to present a business case. Liaise with interested partners and drive business.
- Be adept in utilising the MS Office suite, specifically tools like MS Project, PowerPoint, Excel, and others.

**Requirements - Experience**:

- A Degree in Biological sciences, Immunology, or Chemistry(or allied/specialist scientific field); additional qualifications e.g., MSc or PhD in a relevant bioscience/diagnostic field are desirable.
- A minimum of 10 years’ experience work in or managing ISO 13485 accredited IVD manufacturing projects or environments. Specific experience in the development and or manufacturing of lateral flow assays is preferred.
- Have substantial experience in the understanding the role of manufacturing transfer and routine manufacturing requirements within a comprehensive ISO 13485 design and development environment.
- A proven track record of achieving on time and at cost project delivery.
- Have a thorough understanding of facility ISO accredited validation and maintenance (ISO 13485 or 9001).
- Demonstrated scientific, technical, and commercial problem solving and troubleshooting skills.

**Benefits**:

- Additional leave
- Free flu ja