Department Leader, Product Development

AliveDx; Penicuik; On-site; GBP 70,000 - 95,000; Full time

Benefits offered by this job

Private medical cover

Life assurance

Additional annual leave

Cycle to work

Technology benefits

Experience days

Marketplace discounts

Job summary

AliveDx seeks a Department Leader, Product Development near Edinburgh to guide Alba product development from concept to approval. You will lead, manage and provide scientific direction for assay development, validation and licensure, ensuring regulatory compliance and timely delivery.

You will supervise junior staff, coordinate cross-functional teams, and drive continuous improvement in product quality and processes within a GMP framework.

Qualifications

• Must have experience leading product development projects in a GMP environment.
• Experience in assay development, product validation, and licensure.
• Proven ability to manage staff and deliver projects on time and to quality standards.

Responsibilities

• Lead Alba product development activities to meet customer needs and strategic targets.
• Provide expertise in assay development, validation, and licensure requirements.
• Deputise for Head of Department and drive scientific solutions across projects.
• Oversee complex projects with cross-functional teams and ensure continuous improvement.
• Prepare regulatory-compliant reports and conduct technical reviews.

Skills

Leadership

Project management

Team management

Communication

Blood group serology

GMP knowledge

Training delivery

MS Office

Tools

MS Office

Job description

At AliveDx, we empower diagnostic insights, transform patient care, and innovate for life. With over 30-years in in-vitro diagnostics, we put the health of patients first by creating innovative solutions designed for faster diagnostic results. Alba–– our blood bank reagents portfolio–– and MosaiQ®–– one of the first multiplexing and multimodality automated testing platforms––are designed to make labs more efficient and clinical decision-making more effective. Our journey started as Alba Bioscience, and later, Quotient. Today, as AliveDx, we innovate for life.

DEPARTMENT LEADER, PRODUCT DEVELOPMENT

AliveDx is recruiting for a Department Leader to join the Product Development team based near Edinburgh (EH26 0BF). The role is a full-time, permanent role, working 37.5 hours per week.

The role is designed to lead, manage and provide scientific direction across all aspects of product/process development projects in relation to Alba products. All in accordance with operational objectives, statutory and regulatory requirements, and the principles of GMP in support of products which are marketed worldwide. This will often involve interaction with external parties. Accountable for delivery of projects to timelines and quality expectations.

YOUR MISSION

Your main responsibilities will include:

• Manage the product development activities of Alba products to ensure customers’ needs, strategic objectives and performance targets are met.
• Provide expertise in assay development, product validation, product requirement definitions and licensure.
• Deputise for the Head of Department in product development areas, to drive scientific solutions as required.
• Own/manage custom and complex projects, working with Project Management, troubleshooting and technical/scientific issues to ensure continuous improvement/development of products and processes.
• Analysis and interpretation of complex data sets is required along with report writing for regulatory

approval of Alba products, this includes progress reports with conclusions and proposed actions.

• Chair technical reviews and provides departmental training. Leads scientific workshops to address cross-departmental assay issues, ensuring flawless transition from feasibility to development through to validation and then into commercial approval.
• Lead and troubleshoot complex issues regarding reagent quality and assay robustness, offering support to the wider R&D team as necessary.
• Assist the department in general organisation and administration of laboratory facilities, such as documentation and audits to ensure departmental compliance with health and safety, GMP/GLP standards.
• Assist with the preparation of documentation for regulatory applications including performance evaluations.
• Organisation of routine work within the department to maximise the use of available resources.
• Undertake supervision, training, and appraisals of junior staff to ensure that staff with appropriate skills and knowledge of laboratory organisation and procedures are available to meet the requirements of the department's planned programmes of work.

YOUR COMPETENCIES

• Experience in blood group serology/disease screening is essential plus laboratory experience in a GMP environment.
• Must have sound knowledge and expertise with core IT packages i.e., MS Office. Experience in the provision of training.
• Experience (or confidence if first time manager) in managing staff and directing the work of others.
• Proven leader of teams, motivating character and ensuring priorities are clear.

WHAT WE OFFER

• A highly dynamic and growing environment.
• An opportunity to live your passion for intrapreneurial mindset, where cultivating innovation and customer centricity are at the heart of everything we do.
• A flexible working environment where applicable and a range of core and flexible benefits ranging from private medical cover, life assurance, additional annual leave, cycle to work, technology, experience days and access to marketplace discounts.

AliveDx is an equal opportunity employer and welcomes applications from all qualified individuals regardless of nationality, sex, disability, region/belief, sexual orientation or age. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on competences, performance and business needs.