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Position Summary
The Director, External Manufacturing & Operations, will form a key part of a growing External Manufacturing & Operations function.
This function is growing to meet the business needs of Alexion's expanding CMO network.
This role manages the operational relationship with multiple Contract Manufacturing Organizations (CMOs).
The Director is responsible for operations performance of all external manufacturing within Alexion's Commercial Contract Manufacturing Organization (CMO) network.
This role partners with both internal and CMO functional peers to ensure adherence to Alexion's manufacturing standards, budgets, outputs and schedules.
The Director will partner with internal cross functional stakeholders to ensure that CMO tactical operations are performed to the highest standards across late stage clinical, validation (PPQ), and sustaining commercial operations.
The Director is also responsible for providing significant strategic oversight to the External Manufacturing business within Alexion and as such will sit on the External Manufacturing & Operations leadership team.
The role drives for excellence in PAI and routine cGMP Inspection performance and will support the development of BLA and other regulatory filings.
Lead and direct Alexion and CMO cross functional tiered meeting structures to ensure business objectives and manufacturing, supply and quality deliverables are met.
Ensure issues are effectively resolved and that supply risks are being proactively managed Provide technical and operational expertise to support all aspects of the manufacturing of commercial and late-stage clinical pharmaceutical products at CMOs Lead troubleshooting efforts and high-level deviation investigations in conjunction with CMOs and internal partners Lead the Alexion teams at Local Joint Steering Committee (lJSC) meetings and Global Joint Steering Committee (gJSC) meetings.
Drive internal cross functional alignment on key issues as part of these CMO engagement meetings Identify and lead process optimization initiatives and address opportunities for efficiency, yield, quality and capacity improvements in all areas of manufacturing Identify manufacturing best practices across the network and lead or participate in teams to implement best practices Partner with internal and CMO peers to develop strategy for improving success rates and end-to-end optimization of product supply through the value chain Provide strategic operational oversight for network strategy decisions (CMO selection, S&OP input, etc.)
Partner with Finance to develop a strategic plan for reducing COGs and drive engagement to ensure adherence to plans Partner and lead initiatives with the extended cross functional team to maintain month-on-hand inventory levels at an optimum level Lead development of a risk-based oversight model with our CMO partners to ensure that efforts are appropriately focused as we leverage the CMO network to accommodate Alexion's growing portfolio Provide SME input for IND, BLA and other technical documents for regulatory agency submissions in support of manufacturing processes operated at CMOs Routine travel to CMO sites required
Position Summary
The Director, External Manufacturing & Operations, will form a key part of a growing External Manufacturing & Operations function.
This function is growing to meet the business needs of Alexion's expanding CMO network.
This role manages the operational relationship with multiple Contract Manufacturing Organizations (CMOs).
The Director is responsible for operations performance of all external manufacturing within Alexion's Commercial Contract Manufacturing Organization (CMO) network.
This role partners with both internal and CMO functional peers to ensure adherence to Alexion's manufacturing standards, budgets, outputs and schedules.
The Director will partner with internal cross functional stakeholders to ensure that CMO tactical operations are performed to the highest standards across late stage clinical, validation (PPQ), and sustaining commercial operations.
The Director is also responsible for providing significant strategic oversight to the External Manufacturing business within Alexion and as such will sit on the External Manufacturing & Operations leadership team.
The role drives for excellence in PAI and routine cGMP Inspection performance and will support the development of BLA and other regulatory filings.
Principal Responsibilities
Lead and direct Alexion and CMO cross functional tiered meeting structures to ensure business objectives and manufacturing, supply and quality deliverables are met.
Ensure issues are effectively resolved and that supply risks are being proactively managed Provide technical and operational expertise to support all aspects of the manufacturing of commercial and late-stage clinical pharmaceutical products at CMOs Lead troubleshooting efforts and high-level deviation investigations in conjunction with CMOs and internal partners Lead the Alexion teams at Local Joint Steering Committee (lJSC) meetings and Global Joint Steering Committee (gJSC) meetings.
Drive internal cross functional alignment on key issues as part of these CMO engagement meetings Identify and lead process optimization initiatives and address opportunities for efficiency, yield, quality and capacity improvements in all areas of manufacturing Identify manufacturing best practices across the network and lead or participate in teams to implement best practices Partner with internal and CMO peers to develop strategy for improving success rates and end-to-end optimization of product supply through the value chain Provide strategic operational oversight for network strategy decisions (CMO selection, S&OP input, etc.)
Partner with Finance to develop a strategic plan for reducing COGs and drive engagement to ensure adherence to plans Partner and lead initiatives with the extended cross functional team to maintain month-on-hand inventory levels at an optimum level Lead development of a risk-based oversight model with our CMO partners to ensure that efforts are appropriately focused as we leverage the CMO network to accommodate Alexion's growing portfolio Provide SME input for IND, BLA and other technical documents for regulatory agency submissions in support of manufacturing processes operated at CMOs Routine travel to CMO sites required
Qualifications
Minimum of fifteen years' experience in providing operational / technical support to biologics drug substance manufacturing and drug product manufacturing Extensive knowledge of a variety of drug substance manufacturing platforms (such as mammalian cell culture, microbial fermentation, small molecules, peptides, oligonucleotides, etc.
), drug product and finished product Comprehensive understanding of cGMP requirements for clinical and commercial manufacturing Ability to present and defend technical aspects of manufacturing operations during regulatory agency inspections Demonstrated experience with technology transfers and scale-up of manufacturing processes Experience of working with CMOs demonstrating strong communication and influencing skills Ability to demonstrate strategic thinking and risk management Systems and process development, optimization and implementation
Education
Minimum BS degree in Scientific (Biochemistry, Biology, Chemistry) or Engineering (Chemical, Mechanical) related field.
Advanced degree would be an advantage.
Seniority level Seniority level Mid-Senior level Employment type Employment type Full-time Job function Job function Manufacturing Referrals increase your chances of interviewing at Alexion Pharmaceuticals, Inc. by 2x
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