Contract Manufacturing Manager

About the position

This role is responsible for the supply of products from contract manufacturing organizations (CMO) by management of the business relationship and supply contracts. In particular, the position will provide CMO governance and project management expertise for manufacturing activities. This role will lead the External Supply Operations Team (ESOT), which is the internal cross-functional team whose purpose is to manage day-to-day operations. This role will also be accountable for driving performance improvement and cost saving initiatives for the product.

Responsibilities

• Develop and manage the tactical (day to day operations) and strategic (performance reviews, supplier development) business relationship with assigned Contract Manufacturing Organizations (CMOs)
• Manage new and / or existing business relationships with CMOs in accordance with the GES Governance Policy
• Act as the focus and conduit for communications between the CMO and with members of the GES group and other departments to meet the supply plan
• Lead the External Supply Operations Team (ESOT). Ensuring performance is monitored and actions are in place to drive improvement
• Work with the CMO to deliver an uninterrupted supply of clinical & commercial product
• Identify any supply constraints and negotiate/resolve with the CMO any issues affecting the supply plan
• Be on site at the CMO as necessary to monitor production campaigns and develop an in depth knowledge of the manufacturing process and systems at the CMO
• Develop and manage a visual metric/dashboard on the GES SharePoint providing a single point for information related to the value chain
• Coordinate activities in the evaluation of process changes, change requests and deviations to ensure timely resolution without affecting supply
• Lead and/or participate in technology transfers, new product launches, projects, validation activities with the CMO and internal cross functional teams including Process Development, Regulatory Affairs and Quality departments
• Contribute to the development of formal systems and procedures for the selection of CMOs
• Initiate and implement necessary control systems within budget and to reduce cost of goods
• Manage expenses in relation to CMO spend to ensure compliance to budget and savings targets
• With the Corporate Compliance and Quality departments, ensure that the CMO is compliant with cGMPs
• Manage contracts and negotiations with CMO. Acts as the Contract Monitor, ensuring both parties comply with the obligations of the Supply Agreement and the terms remain relevant to the business
• Support Centre of Excellence team in best-in-class practices, risk management initiatives and compliance improvement initiatives

Requirements

• A minimum of 8 years' experience in the pharmaceutical industry with a strong production management and/or supplier relationship management experience
• Experience in negotiating supply agreements and contracts with outsourced partner and CMOs

Nice-to-haves

• Working knowledge of solid oral dosage manufacturing and packaging processes to enable problem solving and identification of process improvements
• Working knowledge of pharmaceutical regulatory requirements appropriate to level and solid cGMP skills required
• Ability to start up and lead cross-functional teams in the resolution of short-term issues or sustained performance for long-term goals
• Demonstrated ability to project manage technology transfer and/or new product launches
• Use of Lean Six Sigma tools in continuous improvement projects
• Familiarity with an ERP system and Master Control documentation systems are desirable
• Excellent organizational, written and verbal communication & negotiation skills