Fill Finish Technical Manager MSAT

Fill Finish Technical Manager MSAT
Exciting new role for a Fill Finish Technical Manager MSAT in pharmaceutical startup in Waterford City. Reporting to the Head of Operations, the overall purpose of this role is
You will provide technical, engineering and scientific leadership across all disciplines in Sterile Fill Finish Drug Product (DP) for product development, launch product supply and commercial product manufacturing
Responsibilities include:-
  • Lead the Fill Finish MSAT team responsible for product development, formulation and DP manufacturing of parenteral products
  • Coach and mentor a team of technical, scientific and engineering experts in new product introductions (NPI), product and process development, process optimization and tech transfer (TT).
  • Lead the introduction of Single Use Technologies (SUT) for aseptic operations.
  • Lead technical feasibility review and technology gap analysis for NPI.
  • A key member of the Site Operations team for strategic projects.
  • Collaborate with leadership peers in Operations, Engineering, Product Development, Supply Chain and Quality to ensure process improvements and innovation are delivered in a collaborative manner
  • Provide technical oversight and support for all phases of the product lifecycle, including technology transfer, process scale-up, process validation and routine product supply.
  • Provide technical guidance and leadership to the MSAT team and cross-functional project teams for, process development, scale-up, and facility fit for tech transfers.
  • Interpretation of trends observed in process monitoring (including continued process verification (CPV), statistical process control (SPC), multivariate analyses, and technical investigations and process changes that seek to drive improvements to yield and/or process robustness.
  • Drive innovation and continuous improvement in product development. Identify and lead process optimization opportunities for efficiency and capacity improvements in all areas of sterile operations.
  • Drive and deliver on performance KPI’s including: safety, quality, delivery, cost and people
  • Develop your team as a high-performance team – partnering and building on their capabilities to deliver excellence for the site
  • Technical SME for internal and external audits

The ideal candidate will have:-
  • Min. degree level in engineering/production/science related discipline
  • At least 10years’ experience in process development, manufacturing or related technical environment
  • Excellent organizational and leadership abilities
  • Thorough knowledge of industry’s regulations and guidelines
  • Excellent communication and people skills
  • Working knowledge of data analysis and performance/operation metrics