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Supply Development Manager

  • Location:

    Chester, Cheshire

  • Job type:

    Permanent

  • Sector:

    Scientific and Pharmaceutical

  • Salary:

    Negotiable

  • Contact:

    Dameon Hulse

  • Contact email:

    Dameon.Hulse@morson.com

  • Job ref:

    150753DHU_1537890618

  • Published:

    22 days ago

  • Expiry date:

    2018-10-23

  • Start date:

    ASAP

  • Client:

    Morson International

Main Purpose

To lead the operation of the MDI development facility at the client site. To have overall responsibility for the development, definition, agreement, knowledge exchange and supply of data/materials with customers. To Champion the development of systems and resources to establish standards to support the licensing and accreditation of operation for the manufacture of investigational medical products.

Complexity of the job

The role acts as the main day-to-day, contact between the client and Customers and is the lead role at the site. It is required to manage the facility and employees to the standards required by GMP and will be subject to regular customer visits and audits. There are specific SHE hazards that need to be managed related to the handling of Active Pharmaceutical Ingredients

Working in support of customers in a corporate environment requires the job holder to:

Balance the sometime conflicting needs and expectations of internal and external customers;

Effectively cope with change and uncertainty

Focus on quality and elimination of variability in a research environment

Build effective relationships with customers

Drive and self-manage working to GMP high standards

Main Responsibilities

Manage and coordinate laboratory activities for agreed development projects

Supervise laboratory resources to execute projects within allotted budget and time lines

Assess potential project and operational risks. Develop and inform General Manager of risks and appropriate mitigation plans

Ensure laboratory procedures comply with required quality and safety standards and if necessary develop procedures, experimental protocols and work instructions

Ensure the supply of sample materials and experimental data to agreed schedules

Produce timely and accurate technical and management reports for presentation to management and customers

Manage inventory control of materials, equipment and consumable

Support Business Development and promote Business Unit by presenting at technical conferences, seminars and actively support technical networking

Enforce company policies and safety regulations for operational efficiency

Co-ordinate and develop site management system to support the manufacture of investigational medical products

Prepare, agree and manage operational budget

Knowledge Required

Pharmaceutical R&D including device development within cGMP operations

Medical device regulatory programmes

Handling high hazard APIs

MDI device assembly and development

Research programme design and SOP writing

Excellent computer, literacy and numeracy proficiency.

Experience Required

cGMP operation in Respiratory devices

Pharma development programmes

Technical report writing and presenting

Leadership of multi-discipline teams

Working in corporate R&D environment

R&D project definition and delivery

Education

Minimum - Scientific degree with several years experience of pharmacutical development or clinical trail materials production experience.

Desirable

PhD in relevant Chemistry or Pharmaceutical discipline