Senior Analyst (Development)
Job Title: Senior Analyst (Development)
Department: Analytical Development
Reporting to: Team Leader
Responsible for (staff): N/A
General Purpose of Role:
- To provide analytical technical support across the Analytical Services Development Group i.e. training, developing and validating methods, input into technical aspects of business development proposals, assisting in the on boarding of new products, analytical technical support to customers and identification and recommendation of new equipment and techniques.
- To perform routine laboratory procedures right first time with minimal personal OOS results
- To plan and prioritise own work and assist in the planning of other team members day to day workload in line with client requirements and adapt this where necessary in line with client needs and expectations.
- To assist in preparation and review of technical documentation within the Department, as required.
- To ensure that all personal lead times are complied with, subject to the absence of attenuating circumstances.
- To assist in the performance of project work within the team, as required.
- To review analytical and laboratory data within the team for accuracy, completeness and compliance with documented procedures.
- To ensure that all health and safety procedures are adhered to with respect to personal duties and the duties of others.
- To deputise for Team Leader when required, attending meetings and responding to internal queries as required.
- To undertake other laboratory and business related tasks as and when required to meet department and business needs and within the scope of the job-holder’s capabilities and responsibilities
- To undertake such tasks and to manage specific internal or ad hoc projects as and when required to meet department and business needs.
- Actively seeks and demonstrates to perform tasks for the department outside of set analysis activities.
- To identify, raise and progress deviations and change controls when required
- To identify and undertake CI activities in order to continuously improve laboratory standards and encourage others
- Assist in technical trouble shooting when required and to communicate effectively with others on site
- Work in identifying new analytical techniques and training in line with departmental metrics
- Confidently develop and validate analytical methods
- Responsible for assisting in training of new and existing employees.
- Senior Analysts will be deemed competent to train in any technique which they have been considered previously competent to carry out during their previous analytical experience.
- The job holder is responsible for adhering to PCI SOPs, Health & Safety, GMP and other regulatory guidelines.
GMP Requirements Hierarchy
- GMP Skill Level 1 is essential for this role (further information regarding GMP Requirements Hierarchy, can be obtained at SOP-L&D-001)
- A minimum of a first degree, though given the non-routine nature and development element of the role, the job holder is likely to hold relevant post graduate qualifications in addition to the minimum required and on the job experience and skill level is a more critical factor.
- UK Driver’s License / access to transport
Previous Work Experience:
- A passionate and pro-active visionary who constantly strives to drive this arm of the analytical service group and move the business forward.
- A strong technical, detail orientated and quality-minded person.
- Substantial experience in a pharmaceutical environment. Previous experience developing analytical techniques is essential. Proficient in project management tools and a proven ability to manage a fast moving laboratory environment. Proven ability in the management of client projects.
- Multi-functional experience within the laboratory including raw materials testing and development testing.
- Method Development and Validation
- Raw Material testing
- Familiar with lab systems such as Empower
- HPLC trouble shooting
Specific Knowledge / Skills Competence:
- HPLC Theory and maintenance HPLC trouble shooting
- Method Development and Validation
- Familiar with regulatory bodies and guidance relevant to Laboratory testing including Eudralex, ICH.
- Excellent problem solving skills
- Good communication skills
- Good time management
- Honest and trustworthy
- Customer focussed
- Self-motivated and pro-active
- Team Player