Baxter International
Zurich, Switzerland
Scope of the Position:
Manage the Bulk Drug Substance (BDS) products CMO lifecycle including selection, technology transfer, manufacturing, and decommissioning Manage business, operations, and quality relationships and communications between Baxter and the CMOs
Job Duties/Responsibilities:
- Establish and monitor performance objectives and measures for their CMO sites that are aligned with department goals.
- Identify, evaluate and select CMOs who can augment Baxter capabilities for BDS Products.
- Monitor and drive adherence to Baxter’s and CMO contractual commitments, obligations, and processes, including milestone dates, financial terms, and production schedules.
- Track, monitor, and report performance metrics related to operations, quality, cost, and customer service. Develop and distribute periodic reports on CMO performance, issues, risks, and schedules of key activities, events, or milestones.
- Identify, escalate, and facilitate resolution of manufacturing, supply chain, or quality issues that may adversely affect performance goals.
- Participate in establishing, administering, and improving department policies and procedures.
- Work with functional organizations to ensure that technology, operations, and quality standards are defined, documented in contracts and agreements, and implemented consistently at BDS CMO’s. Develop and/or incorporate functional standards into BDS technology transfer and manufacturing / supply contracts, and work with Quality to ensure consistent standards for Quality Agreements are defined, and supported by all other contractual agreements
- Lead contract negotiations for technology transfer and manufacturing and supply agreements.
- Ensure risk assessments and appropriate risk mitigation plans are established for BDS CMO’s at every stage of the Contract Manufacturing Lifecycle.
- Establish, monitor, and work to ensure that Baxter’s expectations and goals for cGMP compliance, product quality, and production (e.g., cost, success rates, yield) are consistently met. Establish and monitor metrics to measure performance of contract manufacturers, and implement periodic CMO operations reviews.
- Track, monitor, and report performance metrics related to operations, quality, cost, and customer service. Develop and distribute periodic reports on CMO performance, issues, risks, and schedules of key activities, events, or milestones.
- Identify, escalate, and facilitate resolution of manufacturing, analytical, supply chain, quality, or issues that may adversely affect performance goals.
Qualifications
- University degree in relevant Science or Engineering discipline.
- Manufacturing (and ideally Contract Manufacturing) experience
- Proven collaboration/influence management, decision making, and leadership skills, and a demonstrated drive for results.
- Excellent written and oral communication skills.
- Overall strong business knowledge of biotech/pharma manufacturing operations, product and process development, and supply chain operations.
- Experience working in a cGMP-regulated environment, including knowledge of relevant US/EU