Job Details
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Location:Smithfield, RI
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Posted:Nov 15
Sr. Manager MFG - Purifcation
Sr. Manager MFG - Purifcation
Data Management: Manufacturing
Location: Smithfield RI
Job Code: 860
Global Level: 9
Description
Alexion Pharmaceuticals, Inc.
Purpose Of The Job
The Senior Manager has responsibility for purification operations in a 24/7 manufacturing facility for commercial manufacturing of biopharmaceuticals. The Senior Manager will provide leadership to the purification team by building a strategic vision for personnel development, process improvement and systems. This position will serve as a subject matter expert during regulatory inspections and be accountable for maintaining an inspection-ready operation at all times. Additionally, the position will be responsible for driving continuous improvement efforts and cross-functional collaboration with other departments within Alexion Pharmaceuticals, Inc. to support company goals and site metrics.
Principal Accountabilities
Develop, implement and monitor departmental objectives and schedules including setting priorities and performance expectations while ensuring alignment with expected deliverables, site metrics, and company goals
Manage and develop a staff of 10 full time manufacturing associates and 2 supervisors
Manage staff to project timelines effectively while ensuring clear and concise communication to plant management
Effectively manage data entry into the enterprise resource planning database to maintain a compliant trace of all raw materials, solutions and consumable items used in the manufacturing process
As appropriate, coordinate and lead deviation, change control and process improvements for area of responsibility, identify root causes and implement appropriate corrective and preventive actions to prevent repeated occurrences
Serve as subject matter expert during regulatory inspections, and collaborate with plant management to address any follow-up responses or corrective actions
Ensure effective interactions with other departments and customer representatives as appropriate to support site metrics
Effectively recruit and develop staff in accordance with company policies in support of effective succession planning
Develop and manage portions of the departmental budget and spending in support of department objectives for cost control while maintaining effectiveness
Job-related Skills / Technical Know-How
Level
Strong working knowledge of cGMP manufacturing operations and ability to maintain regulatory requirements for compliance at all times
Proficient
Comprehensive understanding of logistics constraints of operating large scale equipment in a commercial manufacturing plant, under a rigorous production schedule
Proficient
Must have excellent written, verbal, and presentation skills with a demonstrated ability to work effectively in a fast-paced team environment
Proficient
Strong technical knowledge of purification theory with a demonstrated ability to effectively implement continuous improvement initiatives that will contribute to process robustness
Proficient
Must be able to communicate clearly, effectively, and concisely with subordinates, peers and management
Proficient
Language
Level
Must be able to speak English as a first language
Proficient
Computer Literacy
Level
Must have good working knowledge of MS Excel, Word, Powerpoint, and Project
Proficient
Education
BA/BS in Biology, Chemistry, Chemical Engineering or related discipline
Work Experience
8+ years commercial biopharmaceutical cGMP management, significant experience within a large scale mammalian cell culture biopharmaceutical manufacturing facility