CMO Business Manager
Advertisement Contract Manufacturing Organisation Manager required for start-up Biopharmaceutical based in Dublin
About the company:
Alexion Pharmaceuticals, Inc. is a biopharmaceutical company focused on serving patients with severe and ultra-rare disorders through the innovation, development and commercialisation of life-transforming therapeutic products. They have recently opened up offices in Dublin.
The Business Manager has primary responsibility to oversee and manage the business relationship with contract manufacturing organisations (CMOs) used for the supply of drug substance, drug product and finished product including supply contracts and supplier relationships.
- Ensures uninterrupted product supply from third party manufacturers utilizing support of cross functional teams (QA for vendor GMP compliance, Technical Services for process performance, Finance for vendor payment, etc.).
- Participates in development and implementation of risk management strategies for the company’s supply chain; including product supply and vendor performance.
- Works to eliminate inefficiencies and minimize transactional processing and associated costs related to CMO business relationship.
- Directs and influences third party manufacturers to identify and implement cost savings and process improvements based on inputs from internal partners.
- Ensures continuing compliance of the company’s third party manufacturers with relevant company requirements.
- Run complex Technical Operations projects such as technology transfers, qualification and validation of new CMO sites.
- Define project scope and requirements (costs, timelines, resources).
- Develop high level and detailed schedule for project implementation.
- Define resource requirements and work with functional managers to book required resources for projects.
- Experience in Pharma or Biotech essential.
- Experience in negotiating supply agreements and contracts with CMOs.
- Background in supply chain or planning.
- Good knowledge of bioprocess unit operations or fill/finish operations desirable.
- Experience leading and participating in technical and cross-functional team is required.
- Experience in managing Technical Operations projects in support of technical transfer programs for drug substance manufacture is beneficial.
- Bachelor’s degree or higher preferred.