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AX-7204 External Manufacturing Manager

AXESS Ltd Published: 15th February 2019
Location
Berkshire, United Kingdom
Job Type

Description

Ref: AX-7204

 

JOB SUMMARY

This Global specialty-driven biotech company require an External Manufacturing Manager to ensure effective partnerships with CMO’s and partners to enable supply of externally manufactured radiopharma products.

 

BACKGROUND

  • Global specialty-driven biotechnology group
  • Offer products in oncology and endocrinology amongst others
  • Strong pipeline
  • Launches anticipated over the next 2 years
  • In this key position, the External Manufacturing Manager will manage the product supply and ensure the support functions (quality, regulatory and technical) are involved when required.  They will be accountable for the MSA’s, costs, inventories and managing the supply risks.
  • 30% international travel

 

PRIMARY DUTIES

  • Responsible for the end to end supply chain to ensure availability of outsourced API, Drug Substances or Drug products to company’s plants or affiliates.
  • Identify critical issues, develop action plans and keep stakeholders appraised of any impact upon supply.
  • Implement and be responsible for the S&OP process to ensure end to end supply of product, maintenance of minimum stock levels and raw materials to meet demand.
  • Be the Supply Chain/Tech Ops representative on Joint Steering/Commercial Committees with partners
  • Support the development, implementation and deployment of global SOP’s for the management of entities.
  •  Collect and maintain relevant information on the entities such as contractual terms, financial spend and strategic roadmaps.
  • Build a positive engaged relationship with the entities to be the first point of contact for escalation of issues to Technical Operations.
  • Supervise the collection and review of KPIs (Supply Chain, Finance, Quality, etc.)
  • Drive continuous improvement programs with entities (initiation, implementation and monitoring of approved proposals).
  • Ensure the contract establishment in liaison with legal, commercial operations, finance, purchasing and all internal and external stakeholders.
  • Responsible for the project management of company resources to resolve supply issues and support life cycle management in coordination with all company stakeholders.
  • Manage and support the roll out of global initiatives to entities, e.g. serialisation.

 

QUALIFICATIONS / EXPERIENCE REQUIRED:

BSc in a Life Sciences discipline

Experience in a similar position

Experience of primary or secondary pharmaceutical manufacture in a cGMP environment specifically radiopharmaceutical or nuclear medicine manufacture.

Formal Project Management Qualification and Operational Excellence (Lean Manufacturing) qualification advantageous

Broad knowledge of biotech/pharmaceutical manufacturing processes with excellent scientific analysis and interpretation skills and the ability to creatively problem solve.

Supply Chain/Operations background working with or in contract manufacturing.

APICS certification is an asset.

Understanding of quality (QA and QC) and regulatory requirements at an international level.

Influencing skills.

Ability to network and build relationships (internally & externally).

Professional experience in an international and multicultural environment.

 

BENEFITS:

Corporate

 

TO APPLY:

For a confidential discussion please telephone Rebecca Bray at AXESS Limited on 020 8560 2300.

To apply, please click the APPLY ONLINE  button.

 

KEYWORDS:

Relationship manager, Project Management, supply chain, CMO, CMOs, contract manufacturing organisation, manufacturing, external manufacturer, external manufacturing, operations, supply operations, SOP, SOPs, standard operating procedures, APICS, cGMP, GMP, QA GMP, continuous improvement, Lean Manufacturing, supplier partnerships, process, Technical, Quality, Regulatory, Alliance Management, Purchasing, Corporate Risk Management, Commercial Operations, Legal, Finance, R&D, radio pharma, radiopharmaceuticals, Manufacturing Manager, External Manufacturing Manager, nuclear

 

ABOUT AXESS:

AXESS has been operating since 1990

We are a recruitment business dedicated to the pharmaceutical industry, specialising in Medical Affairs, Regulatory Affairs & Clinical Development

We match professional candidates to the best permanent, contract and interim roles in the market.

 

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