Analytical Project Manager
We are looking to recruit an experienced cGMP Analytical Project Manager to join a team based at our client’s state-of-the-art facility in South Manchester. In this role you will be responsible for creating study plans for and managing a variety of client studies in addition to troubleshooting any issues that arise during study conduct. You will be responsible for ensuring that the studies are conducted in line with client requirements, and in a manner that is compliant with all relevant regulations.
The successful candidate will have a proven track record of managing studies conducted to a high regulatory standard and be experienced in quantitative LC-MS and MS/MS analysis. This will include method validation, high throughput analysis and associated data analysis/interpretation specifically from high complexity analytical samples.
What you’ll do:
- Providing study direction and compliance in accordance with applicable regulatory requirements (ISO17025, cGMP and GLP) and all Company requirements in relation to Health and Safety
- Responsibility for the overall design, scientific and technical conduct of studies, including interpretation, analysis, documentation and reporting of results
- Understanding responsibilities of study personnel specified under GLP regulations
- Liaising with internal and external customers to ensure prompt and proper action on all aspects of the study plans for studies assigned
- Attending and, where appropriate, assisting in key elements of the work of assigned studies including monitoring progress and status
- Leading and participating in study-specific client visits as required
- Assist study management and commercial staff to develop and design studies and communicate with customers to obtain information needed to design studies
- Educate internal stakeholders and customers, as needed on technical aspects of studies
- Coordinate the execution of studies with laboratory personnel and assess capacity
- Verify that studies are performed, documented and completed according to customer expectations and quality system requirements
- As needed, participation at professional conferences and presentations/meetings at customer sites
- Write or review controlled procedures including SOPs, Process Instructions, Test Methods and material specifications.
- Assist in delivering continuous improvement projects relating to, but not limited to, study design and conduct, as required
- Compliance with all Company requirements in relation to Health and Safety
- Effective communication with team member with a collaborative approach across departments
- Help to build a culture that drives employee engagement, creating an enjoyable place to work
The successful candidate will have a chemistry degree (or equivalent) and significant experience in directing quantitative and qualitative analytical studies of complex samples.
Familiarity with working to a cGMP regulatory compliance standard essential and experience with ISO 17025 and GLP would be beneficial.
On this occasion, LiCa Scientific is acting as an employment agency.