Senior Peptide Process Specialist

7 days ago

Cork, Cork, Ireland beBeeSpecialist Full time €75,000 - €100,000
Peptide Process Specialist Job Description

This role is responsible for providing technical expertise in peptide manufacturing processes. The ideal candidate will have a strong understanding of manufacturing principles, cGMPs, and regulatory guidelines.

Key Responsibilities:

  • Provide technical oversight and stewardship for peptide manufacturing processes.
  • Lead resolution of technical issues, including those related to control strategy and manufacturing.
  • Employ excellent communication skills to manage internal and external relationships.
  • Build and maintain relationships with development and central technical organizations.
  • Ensure proper characterization of processes and products and ensure effective documentation of the process description, measures, acceptable ranges, specifications, and the justification of these measures and specifications.
  • Ensure processes are compliant, capable, in control, and maintained in a validated or qualified state.
  • Influence and implement the network technical agenda and drive continuous improvement.
  • Maintain peptide processes in a state of compliance with US and global regulations.
  • Understand the scientific principles required for manufacturing intermediates and drug substances, including the interaction of chemistry and equipment.
  • Operate with 'team spirit' in mind, including coaching and mentoring of peers and other scientists.

Required Skills and Qualifications:

  • Bachelor's in scientific disciplines of Chemistry, Biochemistry, Biology, Pharmacy, or Engineering (Chemistry/Biochemistry strongly preferred).
  • 3+ years of demonstrated experience and proficiency with pharmaceutical manufacturing and working knowledge of regulatory expectations.

Additional Preferences:

  • Knowledge and experience with regulatory requirements.
  • Knowledge of data management practices across manufacturing.
  • Enthusiasm for changes, team spirit, and flexibility.
  • Ability to influence and communicate to diverse groups on business or technical issues within the site and function.
  • Proficiency in delivering complex tasks and/or cross-functional tasks.
  • Demonstrated project management and ability to coordinate complex projects.

Working Conditions:

  • Some travel may be required.
  • Some off-shift work (night/weekend) may be required to support 24/7 operations.

Lilly is an equal opportunities employer and welcomes applications from all suitably qualified individuals regardless of their background. If you require any assistance with your application please do not hesitate to contact us.

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