ANALYTICAL DEVELOPMENT SCIENTIST - UP TO £27K - WILTSHIRE
Industry: Pharmaceutical Production / Quality Control / Quality Assurance
Salary: Circa £27k
Training: Yes (Full).
The post is part of the Analytical Method Development team. The post-holder will assist senior staff in the income generating activities of the Analytical Method Development group by providing scientific support in the development of analytical methods for biopharmaceutical products.
The post holder will assist in activities relating to the development of analytical methods, in particular relating to the analysis of proteins to support analytical development and process development. Tasks will include and major in the operation of HPLC and UPLC systems utilising a variety of separation chemistries in the development of protein analysis techniques. Use of a range of other biochemical methods for the characterisation and understanding of proteins and peptides; preparation of study protocols and reports for both internal and external customers; presentation of work to internal and external customers.
The post holder will have responsibility for supervising junior members of staff as dictated by project requirements as well as hold responsibility for supervising operational laboratories as directed. The post holder will assist in training staff in the use of new equipment and methods and to support the transfer of developed methods to routine testing laboratories including preparation where necessary of technical documentation such as SLP’s, SOP’s, study protocols and study reports. When required they will work to the requirements of European and US cGMPs. The post-holder will maintain up-to-date knowledge of ICH guidelines, European and US Federal Codes as well as other regulatory guidances relating to analytical methods.
MAIN DUTIES AND RESPONSIBILITIES
- To undertake projects ensuring appropriate methods, assays, techniques/systems are implemented and utilised to meet project targets.
- Take responsibility for the provision of reagents and consumables required for the project and documented storage of materials generated.
- To act as a specialist to the project teams assisting in identifying, evaluating and adapting new technologies where appropriate and to assist in ensuring that the project operates to a high scientific standard using current methods.
- Establish links and collaborations within and outside PBL as necessary to benefit the project and/or department.
- Assist senior colleagues, leading where necessary, in developing scientific and technical strategy of the project or derived projects, identifying new opportunities as they arise and responding to funding calls or customer enquiries.
- Take responsibility for the supervision and training of junior staff where appropriate.
- Take responsibility for the supervision of laboratory facilities as directed.
- Provide study protocols and reports as required and lead on preparation of presentations,
- publications and liaison via teleconferences with the customer as well as dealing with
- enquiries as necessary.
- To perform any other duties required by the Line manager commensurate with grade.
- To ensure that the project team undertakes work in accordance with the PBL’s Code of
- Safety Practice and to work within any Quality Systems that are applicable to the site.
- Maintain awareness of Industry and International Regulatory Standards of GxPs and
- implementation where appropriate as dictated by project deliverables.
- To comply with all PBL policies and procedures.
- Degree in Biological Science or Chemistry
- OR extensive experience in pharmaceutical analytical method development
KNOWLEDGE AND EXPERIENCE
- A sound understanding of basic protein chemistry - ESSENTIAL
- Development of HPLC / UPLC based analytical methods for the analysis of biopharmaceutical products. - DESIREABLE
- Experience in use of Waters Empower chromatographic software - ESSENTIAL
- Advanced topic use of Empower software (i.e. system administration and / or custom field design) - DESIREABLE
- Experience in preparing scientific reports and protocols - ESSENTIAL
- General understanding of the application of analytical methods in the development, characterisation and improvement of biopharmaceutical manufacturing - ESSENTIAL
- Good understanding and experience of safe working practices within laboratories - ESSENTIAL
- Experience in the design and execution of studies to qualify or validate analytical methods - ESSENTIAL
PORTON DOWN / WILTSHIRE / SALISBURY / BIOLOGICAL SCIENCE / CHEMISTRY / PHARMACEUTICAL / DEVELOPMENT / ANALYTICAL / METHOD SCIENTIST / PHARMACEUTICAL PRODUCTION / PROCESS DEVELOPMENT / ANALYTICAL DEVELOPMENT / QUALITY CONTROL / QUALITY ASSURANCE / HPLC / UPLC / PROTEINS / SUPERVISOR / TECHNICAL FILES / TECHNICAL DOCUMENTATION / SLPs / SOPs / ICH GUIDELINES / US FEDERAL CODES / cGMPs / METHODS / ESSAYS / TECHNIQUES / SYSTEMS / CONSUMABLES / IDENTIFYING / EVALUATING / ADAPTING / TECHNOLOGIES / PBL / INDETIFYING / ADAPTING
Bank or payment details should not be provided when applying for a job. reed.co.uk is not responsible for any external website content. All applications should be made via the 'Apply now' button.Report this job