Senior Scientist I Immunoassay

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Job Description

Job Responsibilities

• 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 laboratory general 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
• 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
  
  

Other Responsibilities

• 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.
• 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
• Make sure that audit findings, for which you are responsible, are resolved within the allowed time frame
• Contribute to external audits as required
  
  

Skills, Education & Qualifications

• Ph.D. degree with at least 3 years or M.Sc. degree with at least 5 years of working experience in immunology, biochemistry or analytical chemistry (especially in quantitative immunoassay) or an equivalent combination of education, training, and experience as deemed appropriate by management
• Technic expertise in using ELISA or MSD platform to develop and validate methods for pharmacokinetic studies and anti-drug antibody studies
• Family with ICH M10 guidance is a plus
• Thorough understanding of the requirements and applicability of GLP, GCP and 21 CFR Part 11.
• Ability to work effectively in a team and independently
• Excellent communication skills (writing and speaking).
• Knowledge and understanding of the pharmaceutical industry; CRO working experience is desirable
  
  

Technical Specialist: technical lead within the team, with 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/ 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
• Attend 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
  
  

About Us

Are you interested in working in science for a leading global Contract Research Organization that is expanding rapidly and delivering best in class service to its clients? If you are ambitious and hard working then keep reading, as we are looking for talented individuals like you.

We are globally recognised for our leadership in science and, as a result, you will have the opportunity to work with some of our industries smartest and most inquisitive people, in a flexible and supportive environment. It is the ideal place to expand your knowledge, take on new responsibilities and make ambitious strides in your career.

If you want to join us to help us deliver our mission of using our scientific capabilities to improve the quality of life of people, then we would love to hear from you.Seniority level

• Seniority levelMid-Senior level

Employment type

• Employment typeFull-time

Job function

• Job functionResearch, Analyst, and Information Technology

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