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Mylan

Director, Manufacturing Technical Services

Mylan

  • Dublin
  • Not disclosed
  • Permanent full-time
  • Updated 25/07/2012
  • HR
this job is expired
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Description

Director, Manufacturing Technical Services, Gerard Laboratories, Mylan Respiratory

 

 

REPORTING TO: GM/Vice President of Operations

POSITION PURPOSE

Reporting to the GM/Vice President of Operations the purpose of this role is to manage the technology transfer activities from the R & D area into commercial operations. Be a technical resource for conducting investigations (CAPA) as well as process improvements with in the design space.

 ESSENTIAL DUTIES AND RESPONSIBILITIES

To perform this job successfully, an individual must satisfactorily perform each essential duty.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

  1.  Support the efforts to create a commercial manufacturing operations for the DPI platform.
  2. Lead the efforts to transfer technology from R & D into commercial operations.
  3. Manage the technology transfer activities covering a) Analytical method transfer, b) Manufacturing technology transfer including scale-up activities, c) Device assembly and packaging operations.
  4. Participate in the Bespoke equipment design for drugdelivery systems
  5. Develop expertise for the site in micronization, powder handling and device assembly
  6. Be a trouble shooter and help the manufacturing department with investigations (CAPA)
  7. Be accountable for creating, managing department budgets.
  8. Participate in OE activities
  9. Prepare and present KPIs (Key Performance Indicators) and strive to meet the target metrics.
  10. Define and recommend objectives in each area of operation.  Develop specific short-term and long-term plans and programs, together with supporting budget requests and financial estimates.
  11. Establish objectives and procedures governing the performance of assigned activities.  Issue specific annual objectives to immediate subordinates and reviews objectives.
  12. Consult with all segments of management responsible for policy or action.  Ensure compliance within areas of responsibility.  Make recommendations for improving effectiveness of policies and procedures.
  13. Be an effective communicator and have the ability to lead a diverse work environment.
  14. Facilitate training and development of all staff working in the Manufacturing Department.
  15. Manage departmental expenses and focus on Operational Excellence.
  16. Ensure projects are planned, implemented, championed and delivered effectively.
  17. Perform other duties as assigned.

 QUALIFICATIONS

The qualifications listed below are representative of the minimum knowledge, skill, and/or ability required.

 KNOWLEDGE 

Knowledge of the FDA, IMB and other regulatory requirements. Knowledge of handling powders, high potency products, automation and inhalation technologies. Sound administrative skill.  Proven ability to recruit, train, and motivate personnel in order to balance staffing strength with profitability and growth.

 SKILLS AND ABILITIES

Must possess strong analytical, numerical, and reasoning abilities.  Ability to work with diverse personalities.  Good communication skills, written and verbal.

 SUPERVISION

Position functions autonomously.  Position directly reports to the GM & Vice President, Operations.  Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities may include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

 EDUCATION/EXPERIENCE

Minimum of a Bachelor’s Degree in science or engineering with a minimum of 10 years of related experience required.Post graduate education will be definitely an asset.

 LANGUAGE SKILLS

Ability to read and interpret comprehensive and intricate research documents.  Ability to write scientific reports and technical correspondence.  Ability to work with executives and communicate abstract concepts.   Ability to present to a high level of the organization and groups outside of the organization.

 

MATHEMATICAL SKILLS

Advanced mathematics with knowledge of bio-statistics is preferred.

Ref: 19. Dir Manuf Tech Ser
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Mylan

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