Job description Posted 11 January 2024

Development Scientist

12 Months

Montrose

£16-£20p/h PAYE


Job Purpose:


To perform analytical testing work specialising in analytical method/instrumentation development and validation, non-routine API testing, analytical technology transfer, data integrity and pharmacopoeial compliance ensuring that work is performed to GMP and company standards. This will involve activities such as designing protocols and experimental plans, analysing samples, reviewing the work of others and writing reports with limited or no supervision


Key Responsibilities & Accountabilities:


• Perform a range of analytical testing independently and accurately on raw materials, intermediates, APIs or other analytical samples including routine and non-routine testing and interpretation and execution of testing described in protocols.

• Author protocols and/or reports as directed by the Team Leader.

• Work collaboratively with others to ensure that all work for the team is completed on time and to the requisite GMP and safety standards.

• Peer review data generated by other laboratory staff and approve the data for onward communication

• Communicate effectively with customers and key stakeholders.

• Use laboratory IT systems (e.g. CDS, MERPS, KNEAT etc.) at an advanced user level, usually with permissions to approve transactions performed by other staff and provide support to these systems

• Contribute to the preparation of facilities for all Quality and EHS inspections. May lead or contribute to self-inspection.

• Be involved in the procurement, qualification and validation of new equipment, and the management of in-use analytical equipment.

• Hold additional responsibility by acting in an Admin position on analytical equipment and working compliantly to data integrity regulations (including audit trail review).


Knowledge/ Education / Experience Required:


Minimum Level of Education: BSc (Hons) or relevant industrial experience

Area of Specialisation: Chemistry or other science related discipline

Preferred Level of Education MSc

Area of Specialisation: Chemistry or other science related discipline


Job-Related Experience:


Minimum Level of Job-Related Experience required Extensive operational knowledge of analytical chemistry and laboratory equipment, including the ability to diagnose problems and appropriate actions. Full understanding of the requirements of a GMP analytical lab.

 

Other Job-Related Skills/Background List any licenses, certificates, registrations, or any relevant job skill or abilities not covered in Educational Background or Job-Related Experience sections above that are required for the job.

• It is important that the holder of this role has strongly developed IT skills, with knowledge of software such as Microsoft Word, Excel and PowerPoint and lab systems such as MERP.

• Knowledge of pharmacopoeial standards and pharmaceutical registration processes is desirable.

• Knowledge of the importance of data integrity requirements in the pharmaceutical industry is desirable.

• It is essential that the holder of this role is a capable communicator in written, visual and orally and who can engage key stakeholders.

• The holder of this role is a keen problem solver able to undertake analysis of complex situations and make decisions (sometimes working independently).

• Must be able to work under the relevant safety regulations e.g. COSHH