This Technical Plastics company is a specialist in the development and manufacture of bespoke injection moulded components and assembled devices for there customers in the medical, pharmaceutical, diagnostics and eye care industries. Examples of the products they manufacture include:

• Diagnostic Reagent Packs
• Inhalation Devices
• Drug Delivery Devices
• Surgical Disposables
• Point-of-Care Test Cassettes
• Packaging for Contact Lenses

The company understands the regulatory requirements of there customers and validates all of its processes in line with international guidelines. All manufacturing facilities are clean and well-organised, operating to ISO9000.

Responsibilities

1. Manage the introduction of new products, the transfer of existing products (from or to) other sites, or the scale up of existing products.
2. Ensure that all programmes are executed so that the scope, cost, quality and time meet or exceed customer expectations.
3. Work closely with customers to ensure all programme requirements are captured and understood and these are translated into coherent plans.
4. Identify and communicate programme risks to key stakeholders.
5. Assist in the development of the New Product Introduction System to ensure that it continues to meet the needs of the life science market.

Personal Profile for Programme Management Lead

Education:

1. Graduate level in a science or engineering.
2. A qualification in project management would be advantageous – Prince2 or equivalent.

Experience:

1. The candidate would have at least 5 years in project management of which at least 3 years would be in the life science industry - medical devices, diagnostics or pharmaceuticals.

Knowledge Base:

1. Knowledge of Quality Management Systems and applicable regulations or standards used in the Life Sciences, such as; - ISO 9001:2000, ISO 13485:2003, FDA CFR 210/211 & 820, EMEA Medical Device Directive.
2. Knowledge of New Product Introduction process such as - APQP, Design Control, DFSS.
3. Understanding of Drug Development and or Device Development process.
4. Commercially awareness – understand the general strategic issues/developments with industry sector.

Personal Attributes:

1. Must be able to take a flexible approach.
2. Have excellent inter-personal skills – able to network, negotiate, influence and build relationships well within complex situations.
3. Able to analyse, interpret and communicate issues in articulate manner.

If this sounds like the right opportunity fro you please get in touch.