This is an 11-month initial contract.
This is a fully onsite role.
Purpose The Laboratory Analyst has responsibility for Raw Material, Intermediate, and Drug Substance testing to meet compliance requirements and customer targets.
The Analyst may also take a leadership role in change or improvement projects in ADC or at a site level.
The Laboratory Analyst is responsible for ensuring all testing activities comply with cGMP.
The Laboratory Analyst assures compliance with all safety and environmental requirements.
Compliance with other regulated areas such as HR policies are also responsibilities of the role.
Responsibilities To test Raw Materials, Intermediates, Drug Substance, Drug products in accordance with Quality Standard and/or other approved protocols.
To comply with all GMP and analytical procedures relevant to area of work.
To adhere and comply with department High Performance Analytical Behaviours To document all testing activities and to input results into computerised lab systems in accordance with department and our Manufacturing Division standards.
To provide analytical support to product quality investigations and new product demonstrations under the supervision of the Laboratory Leader or designate.
Complete the investigation of laboratory OOSs in line with site and divisional procedures.
Complete documentation checks (e.g.
PCRs, ACRs, Deviations) as required for the Drug Substance/Drug Product test package prior to release.
To complete testing as required on samples to support process changes.
Accountable for own laboratory safety practices.
To provide lead analytical support to product quality investigations and new product demonstrations using own initiative and with minimum supervision.
Provide leadership in the laboratory aspects of OOS investigations.
To identify and aid resolution of analytical issues within the IPT laboratory.
To be a resource for analytical testing for the site as required.
Execute specific assignments (e.g.
stability programme, instrument management and other systems) in a comprehensive manner and under minimum supervision.
Requirements Have knowledge of GMP standards Have knowledge Laboratory safety standards.
Must have good communication skills, both written and verbal.
Strong documentation skills are required.
Must be motivated, focused and technically strong.
To perform analytical testing with a high degree of precision and accuracy To perform instrument maintenance and troubleshooting To maintain accurate records in compliance with GMP expectations To understand and internalise procedures relevant to GMP operations.
To communicate clearly and concisely on technical issues On assignment, to deliver project goals on time.
Analytical chemistry demonstrated ability in all technical elements relevant to ADC IPT operation.
Technical lab skills (precision, etc) Communication - written, oral Team and interpersonal skills Leadership skills Skills: Raw Material Testing Drug Substance Drug Product GMP