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:
- 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
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.
- 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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