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Paula O'Reilly
Life Science

+353 1 507 9265
[email protected]
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Details

Associate Director - Clinical Trial Manufacturing Technical Representative


Reference:POR/551523 Location: Cork
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Manufacturing and Technology Manager

An Associate Director - Clinical Trial Manufacturing Technical Representative, is required to join a leading global pharmaceutical business based in Cork with Hybrid working. This is an opportunity to join a vibrant multi-cultural team where you will play your part in making a difference for people the world over by supporting the business as it discovers, develops, and delivers medicines that help people live longer, healthier and more active lives.

The Clinical Trial Manufacturing organization is responsible for the technical transfer and cGMP activities for drug product supporting clinical trials (Phase 1 through 4) as well as the associated technical information deliverables. CT Manufacturing is performed either externally at approved Third Party Contract Manufacturers, both in the US and OUS, or internally.


The Role

  • Plan and execute cGMP activities for drug product manufacturing. These activities include batch record preparation, oversight of manufacturing execution, sample submission, and batch record review and disposition with Quality for multiple types of manufactures. 
  • Partner with Development Scientists, Third Parties and other groups (e.g., CT Packaging, Regulatory, Quality Assurance, Analytical, Project Management, and Commercial Manufacturing) to enable the manufacturing and delivery of drug product and technical information. Additionally, the Technical Representative works closely with the CT Manufacturing Operations group to enable planning, scheduling, material movement, budget development and other operational deliverables.  
  • Responsible for all activities associated with cGMP Drug Product Manufacturing. Partner with internal team members and manufacturing site to facilitate all required activities leading up to GMP Manufacturing. These activities include technical transfer, authoring of required technical documentation, and batch record review and approval. The Technical Representative is also responsible for overseeing and facilitating resolution discussions during GMP activities. Finally, the Technical Representative is responsible for final review of batch record and partnering with quality assurance for final disposition of drug product batch. 

The Person
  • Minimum of a B.S. in Chemistry, Engineering, Pharmacy, Pharmaceutical Sciences, or similar scientific field 
  • 5+ years in Drug Product Manufacturing, External Manufacturing, Formulation Development or other related function. 
  • Excellent oral and written communication skills, able to communicate clearly with peers and leadership  
  • Ability to clearly identify key issues in manufacturing and lead a team to the appropriate solution(s). 
  • Knowledge of cGMP’s   

For further details please contact; Paula O’Reilly on 00 353 (0)87 7094141 or send CV in confidence to [email protected]