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  • Dublin
  • Not disclosed
  • Not disclosed
  • Updated 14/12/2012
  • HR
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Chemist - Mylan Respiratory


Job Title: Chemist X 4

Reporting to: Analytical Manager 


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 as part of the Mylan Global Respiratory Group Pilot Plant laboratory team, reporting to the laboratory manager. Testing and analysis of raw materials and finished products to support technical transfer, formulation and development, clinical release and stability studies. Laboratory team comprises of Chemists, senior Chemists and Scientists. Will work closely with other members of the pilot plant to support all pilot plant manufacturing activities.


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.

  • Testing and release of raw materials, components and devices to support all pilot plant manufacturing activities
  • Inhalation testing of finished product to support development, scale up, stability and clinical batch manufacture
  • Completion of all relevant laboratory testing documentation using right first time principles
  • Interpretation of data in line with relevant specification and study objectives
  • Reporting and logging of aberrant results using Trackwise™
  • Sample management including logging and tracking of all laboratory samples
  • Compilation of technical documentation including SOPS, test methods and study protocols
  • Analysis of cleaning samples to support cleaning validation studies and all pilot plant manufacturing activities
  • Ownership of  laboratory equipment including routine calibration and maintenance scheduling
  • Planning and organisation of daily and weekly activities
  • Ability to work as part of the pilot plant team including active participation in team meetings
  • Adherence to GMP when performing all analytical testing and laboratory related activities
  • Awareness and compliance to EHS requirements for the laboratory including compilation of risk assessment


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


  • Minimum of a bachelor of Science degree or laboratory practical experience
  • Competent in analytical techniques such as HPLC analysis, particle size analysis and raw material testing
  • GMP awareness and application in a laboratory environment
  • Ability to work as part of a team
  • Self-motivation and willingness to take ownership of role
  • Ability to interpret data in line with study objective
  • Proven problem solving skills

Desirable Experience

  • Testing of inhalation products
  • Calibration and preventative maintenance of instruments
  • Minimum of 2 years relevant experience in an analytical laboratory
  • Good documentation skills including technical report writing
  • Stability testing and knowledge of ICH requirements
  • Experience in using LIMS, Empower and Trackwise™
  • Analytical support for cleaning validation studies and swab analysis
  • Release of device and component to support manufacturing activities
  • Experience in microbiological testing of pharmaceutical products and/or interpretation of data
  • Participation in analytical technical transfers
  • Validation of analytical test methods




This role does not include supervision of others.



Minimum of a Bachelor of Science degree or laboratory practical experience




The physical demands described here are representative of those that must be met by an employee to successfully perform the essential duties of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform essential duties.


Intermittently sitting, standing, walking or stooping, may require significant periods of standing. Occasionally requiring lifting bulk containers of components, raw materials, work in progress samples or finished drug product in line with local manual handling assessments. Typically sitting at a desk or table for office based aspects of role (data entry, report writing etc.). 



The work environment characteristics described here are representative of those an employee encounters while performing the essential duties of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform essential duties.


Laboratory environment.

Ref: Chem - Resp
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