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

• 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 require