Job Description
On behalf of Horizon Therapeutics, we are currently seeking a Manager, Analytical Development to join their Waterford manufacturing site on a permanent basis.
Position Summary:
Reporting to the Senior Director, Technical Development, as Manager, Analytical Development, you will bring broad expertise in analytical development, qualification, validation, testing, technological expertise and data interpretation to the team. You will implement commercial and development assays into the lab to support upstream and downstream drug substance process development /characterization studies. Additionally, you will support drug product heightened characterization via formulation development, process development and liquid and solid-state characterization studies. You will support commercial and development comparability programs and perform analytical product characterization as well as execution of forced degradation studies. You will assist in the development and optimization of new assays and troubleshoot existing assays that are being used for release and stability testing of commercial and development products.
Other responsibilities include supporting analytical deviations and CAPAs, authoring and reviewing analytical protocols and reports and authoring the method development, validation, and comparability sections of regulatory dossiers. The candidate will also be heavily involved in maintaining and enforcing our strong commitment to safety.
Responsibilities:
1. Contribute to the set-up of the Waterford Technical Development analytical lab capability to ensure all required equipment and instrumentation is installed, fit for purpose and available for use.
2. Play a key role in establishing and qualifying assays required for in-process testing and product quality determination to support upstream and downstream process characterization studies
3. Liaise with other Technology Operations team members including the manufacturing and quality functions to provide technical support for in-process and release testing of bulk drug substance/product as required
4. Provide data interpretation and perform data trending and monitoring using statistical methods as appropriate
5. Liaise closely with vendors as well as Horizon functions such as procurement, legal, finance to manage the introduction and set up of lab equipment.
6. Contribute to the technical transfer of analytical methods including qualification, validation activities as well as relevant documentation authoring.
7. Support the establishment of a documentation system to document the introduction and management of equipment.
8. Support general lab equipment maintenance best practices and procedures.
9. Engage with equipment vendors to ascertain equipment best practices and knowledge.
10. Actively partake in safety walkdowns, observations and general safety commitments to ensure a safe working environment for all personnel.
11. Work collaboratively with the Waterford Tech Dev team and the wider stakeholder groups.
12. Contribute to a culture of collaboration, participation, respect, and knowledge development among the team.
13. Adhere to all site safety, environmental and industrial hygiene procedures, and practices.
Qualifications and Skills Required:
14. Minimum of a bachelor's degree in life science or engineering field or diploma qualification plus 5 years' experience.
15. Minimum of 3 years relevant experience in the biotechnology or pharma industry within a lab environment. Direct experience within a development lab or MSAT analytical function will be a plus.
16. Working experience in a bioanalytical/analytical lab function including the use of HPLC/UPLC, capillary electrophoresis (CE), capillary isoelectric focusing (ICE), and bio-analysis technologies is preferential.
17. Strong troubleshooting and understanding of HPLC/UPLC systems including associated detectors (UV, PDA, FLR, CAD, RI etc.). Understanding of key system components (sample loop, lamp hours, detector intricacies etc.) is favourable to have.
18. Good understanding of the biologics manufacturing process e.g upstream, downstream and DP finish fill bioprocessing.
19. Bioassay (HCP, ELISA techniques) and potency assay development experience are highly desirable including bioassay cell culture and cell bank management.
20. Demonstrated experience in method development and troubleshooting.
21. Understanding of method validation parameters and guidelines (ICH Q2, USP 1225).
22. Understanding of a GMP QC environment (CAPA, change control, documentation, protocol/report generation and requirements).
23. Good understanding of chromatographic/electrophoretic/spectroscopic software systems e.g., Empower 3, Chromeleon ,32 karat, ICE3 software, Chemstation, ADL shell, Softmax pro etc.
24. Practical experience with any one or more of the following heightened characterization technologies such as differential scanning calorimetry (DSC), Electron Microscopy, X ray diffraction (XRD), Circular Dichroism (CD), Mass spectroscopy, SOLO VPE, ddPCR will be a strong advantage.
25. Glycan characterization technique experience (N glycan and O glycan) will be an advantage.
26. Demonstrated problem-solving capability and troubleshooting approach (Yellow belt training or mindset).
27. Strong planning and tracking skills, capable of managing multiple projects, excellent time management with respect to priorities and self-management.
28. Excellent judgment and creative problem-solving skills, including negotiation and conflict resolution skills.
29. Proficient in Microsoft Office.
30. Professional, proactive demeanour.
31. Strong interpersonal skills.
32. Excellent written and verbal communication skills.
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