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February 22 2018

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Fill Finish manager:Alexion Pharmaceuticals

Job description:

Fill Finish manager

Alexion Pharmaceuticals


   » Roscommon
   » See description
   » Permanent full-time
   » Updated 12/02/2018
   » HR this job is expired SaveSave Apply Now

Job detail


The manager, Drug Product Operations is responsible for day-to-day management of drug product manufacturing activities completed by Manufacturing Associates at the Alexion Athlone Facility.
 

Internal Job Description Required.
Position Summary

The manager, Drug Product Operations is responsible for day-to-day management of drug product manufacturing activities completed by Manufacturing Associates at the Alexion Athlone Facility. The manager is responsible for ensuring that all manufacturing activities are completed per approved operating procedures and batch records in a safe manner in compliance with cGMPs. Incumbent collaborates with Engineering and Facilities and Maintenance to insure completion of equipment maintenance and repairs, with Quality Assurance to insure all operations meet cGMPs and with Quality Control to insure appropriate monitoring of manufacturing areas.

Principal Responsibilities
   » Support the design, continuous improvement and commissioning of the Athlone facility for the production of drug product.
   » Ensure appropriate training of personnel on equipment, process and facility safety procedures is maintained and up to date.
   » Troubleshoot and resolve operational problems during processing
   » Create and Review batch records and other manufacturing process records
   » Routinely draft and revise standard operating procedures and master batch records
   » Recognize and initiate process deviations. Perform deviation investigations and closure
   » Facilitate process design review supporting RFT execution.
   » Support continuous improvement initiatives by identifying areas needing improvement, recommending strategies for improvement, and implementing those strategies once approved
   » Build and sustain employee engagement by creating a culture of efficient execution and an environment in which individuals and teams can excel and continuously improve.
   » Support all commissioning activities including FATs and test script execution.
   » Set the GMP expectation for the clean rooms and ensure manufacturing associates are proficiently trained.
   » Coordinate and facilitate everyday Operations tier meetings.
   » Manage multiple projects independently
   » Interact with regulatory agencies.
   » Plan and implement complex changes
   » Technical expert for entire area(s)
   » Integrate and collaborate with cross functional teams setting the operations expectations and driving execution.
   » Maintain a high, and continuously improving, level of GMP compliance to ensure patient safety and to minimize risk to the company business. Support Regulatory licensure activities, including agency inspections. Provide skills and leadership abilities in formulating inspection responses.
   » Maximize the success rate for production operations by instituting programs to minimize failures. Support strategic plans for plant improvements in order to increase efficiency and drive down costs.
   » Communicate operational status regularly to plant management at the appropriate level of detail. Communications will be both written documents, and in formal and informal oral presentations
   » Recruit, retain and develop first class staff. Build and sustain employee engagement by creating a culture of efficient execution and an environment in which individuals and teams can excel and continuously improve.
   » Ensure that manufacturing areas are appropriately designed, maintained, validated and approved for manufacturing activities. Ensure appropriate training of personnel on equipment, process and facility safety procedures is maintained and up to date.
   » Facilitate strategic planning of the manufacturing operations schedule.
   » Complete operational activities in conformity with applicable procedures, corporate policies, and cGMP.
   » Work with other departments to understand future needs and to adhere to the production schedule
   » Trend issues and performance for business review meetings.
   » Provide SME support for the area during regulatory inspections for Athlone.
   » Responsible for change controls, deviations and CAPA's related to Operations
   » Develop and implement metrics.
   » Review and approval of SOPs, master batch records, policies, operational standards, validation protocols and reports to meet the needs of Clinical and Commercial Operations groups.
   » Capable of performing, monitoring, and resolving all SAP transactions supporting department
   » Ensures compliance with designated hazardous materials regulations
   » Provide performance reviews to direct reports; counsel and discipline under-performing employees
Qualifications

• 3-6 years' practice in aseptic filling operations in a GMP environment with at least 1 year in a managery position
• Must be able to work within and adapt to complex electronic systems such as SAP
• practice with different filling equipment and control approaches (e.g. RABS and isolator) preferred.
   » Excellent knowledge of cGMP significant to Fill Finish operations an advantage.
   » Excellent interpersonal, persuasion and communication skills.
   » Customer service oriented, self -directed, responsible, and able to work on problems of moderate scope involving various cross-functional groups.
   » Flexible and comfortable with ambiguity.
   » Direct practice of GMP within a pharma/biopharma company including exposure to FDA, HPRA or other authorities of similar standing.

Education
   » Third level qualification e.g. B.Sc in Science, Engineering or other significant qualification preferred

*LI-GO1
Position Summary

The manager, Drug Product Operations is responsible for day-to-day management of drug product manufacturing activities completed by Manufacturing Associates at the Alexion Athlone Facility. The manager is responsible for ensuring that all manufacturing activities are completed per approved operating procedures and batch records in a safe manner in compliance with cGMPs. Incumbent collaborates with Engineering and Facilities and Maintenance to insure completion of equipment maintenance and repairs, with Quality Assurance to insure all operations meet cGMPs and with Quality Control to insure appropriate monitoring of manufacturing areas.

Principal Responsibilities
   » Support the design, continuous improvement and commissioning of the Athlone facility for the production of drug product.
   » Ensure appropriate training of personnel on equipment, process and facility safety procedures is maintained and up to date.
   » Troubleshoot and resolve operational problems during processing
   » Create and Review batch records and other manufacturing process records
   » Routinely draft and revise standard operating procedures and master batch records
   » Recognize and initiate process deviations. Perform deviation investigations and closure
   » Facilitate process design review supporting RFT execution.
   » Support continuous improvement initiatives by identifying areas needing improvement, recommending strategies for improvement, and implementing those strategies once approved
   » Build and sustain employee engagement by creating a culture of efficient execution and an environment in which individuals and teams can excel and continuously improve.
   » Support all commissioning activities including FATs and test script execution.
   » Set the GMP expectation for the clean rooms and ensure manufacturing associates are proficiently trained.
   » Coordinate and facilitate everyday Operations tier meetings.
   » Manage multiple projects independently
   » Interact with regulatory agencies.
   » Plan and implement complex changes
   » Technical expert for entire area(s)
   » Integrate and collaborate with cross functional teams setting the operations expectations and driving execution.
   » Maintain a high, and continuously improving, level of GMP compliance to ensure patient safety and to minimize risk to the company business. Support Regulatory licensure activities, including agency inspections. Provide skills and leadership abilities in formulating inspection responses.
   » Maximize the success rate for production operations by instituting programs to minimize failures. Support strategic plans for plant improvements in order to increase efficiency and drive down costs.
   » Communicate operational status regularly to plant management at the appropriate level of detail. Communications will be both written documents, and in formal and informal oral presentations
   » Recruit, retain and develop first class staff. Build and sustain employee engagement by creating a culture of efficient execution and an environment in which individuals and teams can excel and continuously improve.
   » Ensure that manufacturing areas are appropriately designed, maintained, validated and approved for manufacturing activities. Ensure appropriate training of personnel on equipment, process and facility safety procedures is maintained and up to date.
   » Facilitate strategic planning of the manufacturing operations schedule.
   » Complete operational activities in conformity with applicable procedures, corporate policies, and cGMP.
   » Work with other departments to understand future needs and to adhere to the production schedule
   » Trend issues and performance for business review meetings.
   » Provide SME support for the area during regulatory inspections for Athlone.
   » Responsible for change controls, deviations and CAPA's related to Operations
   » Develop and implement metrics.
   » Review and approval of SOPs, master batch records, policies, operational standards, validation protocols and reports to meet the needs of Clinical and Commercial Operations groups.
   » Capable of performing, monitoring, and resolving all SAP transactions supporting department
   » Ensures compliance with designated hazardous materials regulations
   » Provide performance reviews to direct reports; counsel and discipline under-performing employees
Qualifications

• 3-6 years' practice in aseptic filling operations in a GMP environment with at least 1 year in a managery position
• Must be able to work within and adapt to complex electronic systems such as SAP
• practice with different filling equipment and control approaches (e.g. RABS and isolator) preferred.
   » Excellent knowledge of cGMP significant to Fill Finish operations an advantage.
   » Excellent interpersonal, persuasion and communication skills.
   » Customer service oriented, self -directed, responsible, and able to work on problems of moderate scope involving various cross-functional groups.
   » Flexible and comfortable with ambiguity.
   » Direct practice of GMP within a pharma/biopharma company including exposure to FDA, HPRA or other authorities of similar standing.

Education
   » Third level qualification e.g. B.Sc in Science, Engineering or other significant qualification preferred

Ref: 11503
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Alexion Pharmaceuticals


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5 reviews

 


   » Alexion International Trading, College Business & Technology Park, Blanchardstown, Dublin 15
   » +353 (0) 1 254 6400
   » http://www.alexionpharma.com



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Job Category: Customer Service [ View All Customer Service Jobs ]
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Employment type:
Salary: Unspecified
Degree: Unspecified
Experience (year): Unspecified
Job Location: Roscommon
Company Type Employer
Post Date: 02/12/2018 / Viewed 3 times
Contact Information
Company: Alexion Pharmaceuticals


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