BPI Immunoassay

Responsibilities As a member of Immunoassay Bioanalysis, you are expected to; · Have a good knowledge of and perform regulated studies to the appropriate GLP/GCP standards and latest regulatory guidelines. · Be familiar with, and work in accordance with, SOPs and Study Documents · Complete all paperwork in compliance with good record keeping principles, correctly and on time · Be able to accurately communicate the outcomes of your experiments and show effective problem solving · Make suggestions for how processes can be improved and be involved in their implementation. · Drive your own personal development, seek out training, and look for opportunities to grow · Embrace and actively promote the Laboratory Charter, keeping your work areas clean and tidy, being respectful to your colleagues and acting as a role model to more junior members of the department · Take your turn in reagent rota, cleaning rotas and other lean and housekeeping activities · Be flexible and productive; realise that timelines, priorities and requirements will change regularly and respond to these challenges positively · Take responsibility for knowing what needs to be done in a day, and doing it promptly · Be familiar with, and work to the Health and Safety Policy relevant to your role, paying particular attention to COSHH in the lab · Build and maintain good working relationships with internal and external clients, management and other scientific staff · Familiarity with the financial aspects of projects including time spent and materials costs · Complete any Mandatory Training appropriate for your role. Other responsibilities Act as a go to person for advice and guidance of other team members As well as managing your own work, play an active role in supervising junior members of the department in the laboratory Can develop a method for challenging compounds by application of knowledge and experience without supervision. Application of advanced biochemical techniques used for protein modification Oversee day to day sample analysis, take appropriate decisions and advise junior members of the team how to proceed. When requested, review proposals and highlight any concerns to the Team Leader or Business Development Help raise the profile of Resolian by looking for suitable opportunities to publish or present your work, both internally and externally. Responsible for review and approval of data, making good scientific judgements, and maintain regulatory compliance, and set a good example to others in the team. When the opportunity is available, undertake the role of trainer, including delivery of additional on the job, or role specific training for other members of the department Communicates workload to line manager and makes sure that day to day workload is manageable, helps other team members to identify periods of high or low workload, and offers appropriate advice Manage your opportunities outside of your core role, contributing without effecting your day-to-day responsibilities Take a lead/specialist role in the team, acting as SD/PI/BPI, technical specialist, or other key position. Regardless of specialism, the two roles require a strong performance in both areas. SD/PI/BPI; Assume the role of Study Director / Principal Investigator / Bioanalytical Principal Investigator for regulated GLP / GCP studies as appropriate Consider sample numbers, fast turn round and other activities so that out of scope activities can be captured by the Team Leader or Business Development Present the progress of development, validation and sample analysis studies confidently, both internally and to the sponsor, using email, PowerPoint and teleconferences as appropriate Plan and execute day to day study activity, maintaining a good understanding of the Sponsor’s goals and requirements Prepare plans and reports to a high quality, taking into account any Sponsor specific requirements Make sure that data for which you are responsible is appropriately QC checked Make sure that audit findings, for which you are responsible, are resolved within the allowed time frame Contribute to external audits as required Technical Specialist: technical lead within the team, with some responsibility for assay development, delivery of training and best practice Present the progress of assay development confidently, both internally and to the sponsor, using email, PowerPoint and teleconferences as appropriate Highlight when method development takes longer than planned so that out of scope activities can be captured by the Team Leader or Business Development Awareness of the development end points, timelines, sensitivity and assay performance required Support the SD/PI/BPI by producing robust methods Seek input and advice on assay transfer from all team members and wider technical specialist group Maintain an interest in methods which you have transferred and their progress through the validation and sample analysis phases. Troubleshoot as required A champion of best practice Attend Technical Specialist meetings, contribute, and share your knowledge within your team Ensure all written records are to a good standard, regardless of the GXP status of the study. Identify new technologies that could expand our service offering Present technical and/or scientific content at internal meetings Actively mentor scientists Skills, Education & Qualifications · BA/BS or higher with substantial lab experience; all experiences will be evaluated · PhD in relevant field with 3-5 years lab experience · Knowledge and understanding of regulatory requirements; GLP, GCP, 21CFR Part 11, GDP, GMP · Able to independently develop and perform complex lab work · Able to work in a regulated environment · Able to work effectively and contribute within a team · Able to work with computer systems · Able to document clearly · Able to communicate clearly · Knowledge of and experience in a regulatory environment