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Mylan

Drug Products Operations Manager

Mylan

  • Dublin
  • Not disclosed
  • Permanent full-time
  • Updated 19/12/2012
  • HR
this job is expired
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Description

Drug Products Operations Manager - Mylan Respiratory

 

Job Title: Drug Products Operations Manager

Reporting to: Head of the Pilot Plant

POSITION PURPOSE

A brief summary of the purpose this position must fulfill.

Mylan Global Respiratory Group is building a team at our new facility in Dublin, Ireland, that will be responsible for pilot scale manufacturing, analytical testing and quality assurance of new inhalation drug products. The team will be part of Mylans Global R&D group with close links to commercial manufacturing.

Works in the Mylan Global Respiratory Group (MGRG) Pilot Plant on dry powder inhaler projects under the supervision of the Head of the Pilot Plant operations.  An experienced Process Development Scientist, Pharmaceutical Engineer or Manufacturing Operations Manager responsible for leading and managing powder processing operations including micronisation, blending and bespoke powder filling technology.  Works with other R&D colleagues on Dry Powder Inhalation (DPI) development projects across MGRG to design and execute product development activities and technical transfer of new products into the pilot plant in Dublin and subsequently into the Commercial Manufacturing Facility. Manages matrix team and schedules activities for powder processing activities (micronisation, blending and filling process development) for both product development programmes and clinical manufacturing campaigns.  Collaborates closely with other Pilot Plant disciplines to maintain GMP compliance and delivers high quality results within a cGMP environment.

Key skills and experience include:

  • A deep understanding of powder processing and equipment used for manufacture of powder dosage forms in an R&D and/or a GMP manufacturing environment (blend processing of powders essential; filling equipment of powder systems preferred; inhaled product development preferred).
  • Some experience of Materials Science as applied to powder systems and processing would be beneficial including micronisation processing.
  • Experience of clinical trials or late stage development manufacture to cGMP, process development and scale-up of dry powder pharmaceutical products is required (inhaled product development experience preferred). 
  • Contemporary understanding of cGMP regulations/guidance in relation to all aspects of clinical manufacturing and a solid grasp of relevant scientific and technical aspects of role.
  • Experience of Technical Transfer of products and processes into a commercial manufacturing environment is desirable.

Preferred:

The ideal candidate will be a qualified, experienced pharmaceutical professional with a track record of success.

  • Minimum of a third level qualification in Pharmacy, Chemistry or related discipline.
  • At least 5 years relevant technical experience in a highly regulated environment in Europe or US (IMB/FDA).
  • Track record in managing and motivating a team and delivering results through people.
  • An understanding of Lean Principles/Operational Excellence tools and "hands on" implementation of same in a pharmaceutical environment.
  • Strong organisational skills with the ability to multitask and prioritise workload in a fast moving environment
  • Excellent verbal, written and interpersonal communication skills with the ability to interact effectively at all levels within the organisation

Ref: DP Ops Mgr Resp
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