Analytical Functional Lead

  • Dublin
  • Permanent
  • JO-1908-64684_1565097433

Summary

Principal Responsibilities

The Analytical Team provides analytical leadership and support to the Process Development teams. The current range of analytical services include HPLC/UPLC, GC-FID, GC-MS, online HPLC as well as API solid-state characterisation techniques (TGA, DSC, XRD, Malvern, SEM). Analytical support for our biologics, gene therapy and cell-therapy programs include a comprehensive suite of chromatographic and electrophoretic techniques for protein characterisation, ELISA, flow cytometry, Malvern Zetasizer Nano, plate-based bioassays, qPCR and a range of rapid at-line techniques for cell-counting and targeted profiling of key metabolites.

The Analytical Functional Lead will have the following responsibilities:

People leadership

  • Lead people in line with the values of the company and develop people within the function so that they can deliver excellent science to all projects
  • Identify the resource needs for the function and assist recruiting of those personnel
  • For each team member, set objectives, manage performance and give feedback, have 1:1's, create a development plan over time that includes CPD. Complete the PM review, calibration, salary letter and promotions processes for all team members
  • Hold staff meetings to promote 2-way communication
  • Ensure implementation of HR policies and guidelines as regards the team including recognition

Deliver the functions capability to successfully complete of projects to targets

  • Ensure functional delivery to Projects through proactive people resourcing to projects and (in partnership with Senior Technical Leads) ongoing monitoring of functional performance within projects (including escalation/resolution/prioritisation of issues)
  • Proactively responsible for the function's technical delivery across all projects
  • In partnership with Senior Technical Leads and CTO, develop and implement improvements to analytical capability and excellence
  • Manage analytical equipment scheduling to projects including prioritisation
  • Own business case for Capex, and develop same in partnership with Senior Technical Leads
  • Jointly responsible with other leads, for cross-functional communication and partnership to deliver projects
  • In partnership with the Analytical Technical Lead, perform functional review of project scopes to ensure alignment with Team capability and capacity.

Set the culture/tone, ensure standards are maintained, support business processes

  • Set and maintain the Safety and Quality culture of the function
  • Act as footprint owner for the Analytical area and ensure tasks done
  • Support commercial activities (Visits/calls, prospecting)
  • Implement improvements based on feedback and changing company requirements
  • Keep current with developments in analytical methodologies and make recommendations for implementation of new methods/equipment.
  • Influence through interaction with management, business processes so as to be practical for the functional teams

Minimum Experience

You will have:

  • PhD in Analytical Science or related discipline or equivalent
  • Minimum of 5 years' industry experience in Analytical Sciences management, preferably in a pharmaceutical/biotech industry.
  • Evidenced track record in Analytical input to pharmaceutical process design projects.
  • Demonstrated broad technical understanding of analytical methodologies for drug substance and drug product, either for small molecules or biologics.
  • Experience in mentoring and developing team member's skills and overseeing training programmes.
  • Experience in the Analytical requirements of areas such as process chemistry, chemical engineering, crystallization, analytics, PAT, process modelling, DoE, QbD, continuous processing and designing scale-up strategies for pharmaceutical processes.
  • Experience in the analysis of protein biologics (mAbs), vaccines, cell therapies; including chromatography, electrophoresis, spectroscopy, cell-based bioassays, molecular techniques and mass spectrometry.
  • Experience of regulatory requirements related to analytical method qualification, phase-appropriate method validation and analytical method transfer.
  • Proven track record in internal and external technical communication, preferably with contract manufacturing organisations or contract analytical organisations.

Personal Characteristics

  • Excellent collaborative leadership and people management style
  • Passion for the function and commitment to the success of the company
  • Good communication skills with the ability to work cross-functionally
  • Excellent oral and written communication, organisational and planning skills
  • Good organisational skills with an ability to prioritise and to meet set deadlines.

Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.

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