Development Analyst – Level 2
Job Title: Development Analyst – Level 2
Department: Analytical Development
Reporting to: AS Team Leader
Responsible for (staff): N/A
General Purpose of Role:
- To perform the Analytical testing function in an efficient and effective manner in full compliance with relevant documented procedures and pertinent regulatory/company requirements.
- To perform routine laboratory procedures right first time with minimal personal OOS results and if relevant and instructed to do so, to assist others within the team.
- To plan and prioritise own 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 of technical documentation within the Department, as required.
- To assist in training of others, as required.
- To ensure that all work carried out complies with departmental procedures and is cGMP compliant
- 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 assist in the development and validation of laboratory procedures within the team, as required.
- To review analytical and laboratory data within the team for accuracy, completeness and compliance with documented procedures.
- To communicate effectively with others on site and to assist with departmental problem solving as required.
- To ensure that all health and safety procedures are adhered to with respect to personal duties and the duties of others.
- 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 and within the scope of the job-holder’s capabilities and responsibilities.
- Self-motivated to gain additional pharmaceutical Development Knowledge.
- Actively seeks and demonstrates to perform tasks for the department outside of set analysis activities.
- 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 degree in a scientific subject as a minimum (preferably Chemistry).
- UK Driver’s License / access to transport
Previous Work Experience:
- Previous laboratory and analytical experience essential (minimum 1 year), preferably in a pharmaceutical environment.
- Practical HPLC usage
- Method Validation Experience
- Familiar with lab systems such as Empower
Specific Knowledge / Skills Competence:
- HPLC Theory
- Method Validation
- ICH guidelines
- Regulatory bodies
- Good communication skills
- Good Time management
- Honest and trustworthy
- Customer focussed
- Self-motivated and pro-active
- Team Player