Job Description

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The Opportunity:

Reacta Healthcare is an entrepreneurial and fast-growing organisation, positioned for great things! We have a fantastic opportunity for a Senior Bioanalytical Scientist to join the team. This role, reporting to the Analytical Development Manager, will lead and undertake analytical development activities for existing Reacta Healthcare products and new product development (NPD). The successful candidate will also be responsible for analytical procedure development and validation for analysis of excipients, active ingredients and finished products.


The role includes the following key accountabilities:

Key Accountabilities:

Manage and monitor analytical procedure development, validation and transfer activities carried out by external contract analytical laboratories. Be an integral part in defining and developing the strategy of bioanalytical procedure development and validation at Reacta. Plan and manage internal projects for analytical procedure development or improvement as identified. Closely collaborate with analytical development team members in experimental design. Develop analytical procedures for the analysis of Reacta products and ingredients (in a phase appropriate manner). Validate analytical procedures to internationally recognised regulatory guidelines. Transfer analytical procedures into routine QC testing. Generate and execute protocols, interpret data and generate scientific reports. Design work plans and projects with a compliance development mindset, i.e. cGMP adherence. Work to cGMP and GLP; adhere to strict guidelines on documentation when recording data and working in the laboratory. Analyse samples from various sources using a variety of analytical techniques and instrumentation, including: ELISA, SDS-PAGE, immunoblotting and FTIR. Review data in accordance with cGMP. Trend and perform statistical analysis of data when relevant. Provide guidance, support, mentorship and/or training to other team members and QC, as required. Supervise other analysts/scientists, as required. Present data and findings to peers and management, as required. Update analytical procedures (test methods) and other analytical development or laboratory documentation and procedures to ensure that theyre up-to-date and, where applicable, reflect current regulatory and/or pharmacopoeial requirements. Work collaboratively in cross-functional teams, troubleshoot to solve technical problems, and communicate effectively. Ensure that there are no delays as a result of insufficient laboratory supplies. Liaise with customers, co-workers and suppliers in order to achieve the corporate goals of Reacta Healthcare. Maintain quality standards within the analytical development team and ensure commitment to the quality system, including supporting audits by both internal and external parties. Respond to unscheduled deadlines, client needs, etc., without neglecting other duties.

Essential Skills, Qualifications and Experience:

To be successful in this role, applicants need to have the following essential skills and experience:

Essential:

Degree (BSc or equivalent) in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or similar scientific discipline, and substantial industry bioanalytical experience; or, MSC or Ph.D. in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or similar scientific discipline, with proven relevant industry bioanalytical experience. Experience of working within an accredited laboratory, preferably to cGMP. A working knowledge and extensive practical experience with development and validation of a range of bioanalytical procedures using techniques such as: immunoassay (e.g. ELISA), immunoblotting and electrophoresis (particularly SDS-PAGE). Able to work independently (prioritise and schedule own work) with the motivation and confidence to investigate and solve complex problems. Excellent organisational skills and interpersonal skills. Excellent oral (including presentation) and written communication skills. IT competent (e.g., Microsoft Word, Excel, PowerPoint, etc). A good standard of numeracy and skills in data analysis. Experience of statistical analysis of analytical data. An understanding of chemical food safety, pharmaceutical analysis, and food matrix validation. Knowledge of different types of accreditations (ISO17025, pharma GLP/GMP).

Desirable:

A working knowledge and practical experience with development and validation of a range of analytical procedures using techniques such as: HPLC, UV, FTIR and LCMS.

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