Description
Our client, an expanding pharmaceutical company, are looking for a Commercial Contract Manufacturing Manager to join their Manufacturing Operations group based in South East England.This is an important role within the company and requires an experienced leader to support the management of manufacturing operations with the client's external contract manufacturers and suppliers.
The key aspects of the role will be managing the outsourcing of activities associated with API Manufacture and Drug Product operations from both a Technical and Commercial perspective.
Reporting initially to the Site Director you will be need to:
* Develop and agree manufacturing plans internally with Supply Chain.
* Develop and put in place supply contracts with the external Contract Manufacturing Organisations (CMOs) and external suppliers.
* Deliver external manufacturing plans on time, and in full, to the quality specified in the technical agreements; and on budgeted cost of goods.
* Manage approved budget and expenses for external manufacturing operations. To manage the commercial contracts.
* Ensure outsourcing and contract manufacturers are fully compliant with cGxP and support internal and external audits. Ensure facilities are ready to support regulatory inspections (FDA and MHRA).
* Ensure contract companies meet the necessary standards and company policy requirements for Environmental, Health & Safety.
* Develop Operational Excellence initiatives and adopt best practices to make productivity and cost of goods improvements with external suppliers.
* To work with suppliers to develop Key Performance Metrics
* To act as the main point of contact between external partners and site functional groups, specifically quality, regulatory, technical and operations. To ensure good and timely communication with all functional areas and management.
* To help manage change controls, alerts, deviations, complaints, OOS and ensure these are executed and closed out in a timely manner. To ensure Quality and/or Technical Agreements are in place with external suppliers and ensure compliance requirements.
* To oversee troubleshooting and resolution of product quality and technical problems with external contract suppliers.
* To issue regular status reports on schedule, compliance, manufacturing output and cost.
Knowledge, Skills and Experience Required:
* A background in Manufacturing or Supply Chain is essential.
* A science or engineering background would be preferable, qualification to degree standard would be an advantage
* Will have a demonstrated track record with relevant experience working in a regulated industry.
* Proven Commercial Operations experience.
Please apply now for more information!