· With a high degree of technical flexibility, work across diverse areas within the lab
· Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays.
· Report, evaluate, back-up/archive, trend and approve analytical data.
· Troubleshoot, solve problems and communicate with stakeholders.
· Initiate and/or implement changes in controlled documents.
· Participate in audits, initiatives, and projects that may be departmental or organizational in scope.
· Write controlled documents, perform assay validation and equipment qualification/ verification.
· Introduce new techniques to the lab, including method transfers, reports, validations and protocols.
· Evaluate lab practices for compliance and operational excellence improvement on a continuous basis.
· Approve lab results
· Bachelor's degree in a Science related field
· Minimum of 3+ years in a GMP lab
· Experience in a wide variety of analytical techniques including but not limited to HPLC, Gels, Capillary Electrophoresis, pH, Appearance, Colour, Clarity, Sub Visible Particle testing, Osmolality, Protein Concentration, Polysorbate, Moisture and Device testing.
· Understanding and application of principles, concepts, theories and standards of GMP QC analytical laboratories. Deepens technical knowledge through exposure and continuous learning.
· Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery
· Confident communicator who can work under minimum supervision
· Candidates that can take ownership of their responsibilities
· Team player
This role will support manufacturing operations, as such some extended hours, weekend or shift work flexibility may be necessary as required.
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
Fastnet - The Talent Group
'Not Just Placers.........Partners'
The Life Science Specialists