Sr. Scientist I Immunoassay, Resolian, Australia

Job Description

About the job

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

· 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

Apply: https://www.linkedin.com/jobs/view/4231941229/?

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