Discover a challenging role in our rapidly expanding science organization.
We are globally recognized for our leadership in science, providing a flexible and supportive environment where you can expand your knowledge, take on new responsibilities, and make ambitious strides in your career.
Key Responsibilities:
* Maintain a good understanding of regulated studies to the appropriate GLP/GCP standards and latest regulatory guidelines.
* Be familiar with SOPs and Study Documents.
* Ensure accurate and timely completion of all paperwork in compliance with good record-keeping principles.
* Effectively communicate the outcomes of experiments and demonstrate problem-solving skills.
* Contribute to process improvements and implement changes as needed.
* Drive personal development, seek out training, and look for opportunities to grow.
* Embody and promote our Laboratory Charter, maintaining clean and tidy work areas, respecting colleagues, and serving as a role model to junior team members.
* Participate in laboratory general housekeeping activities.
* Demonstrate flexibility and productivity in response to changing timelines, priorities, and requirements.
* Take ownership of tasks and complete them promptly.
* Familiarize yourself with and work to our Health and Safety Policy relevant to your role.
* Develop and maintain positive working relationships with internal and external clients, management, and scientific staff.
* Understand financial aspects of projects, including time spent and materials costs.
Additional Responsibilities:
* Supervise junior team members in the laboratory.
* Develop methods for challenging compounds using your knowledge and experience without supervision.
* Review proposals and highlight concerns to the Team Leader or Business Development when requested.
* Identify opportunities to publish or present your work internally and externally.
* Assess data, making sound scientific judgments, and ensure regulatory compliance while setting a good example for others.
* Resolve audit findings within the allowed timeframe.
* Contribute to external audits as required.
Required Skills and Qualifications:
* Ph.D. degree with at least 3 years or M.Sc. degree with at least 5 years of experience in immunology, biochemistry, or analytical chemistry (especially in quantitative immunoassay) or an equivalent combination of education, training, and experience deemed appropriate by management.
* Technical expertise in ELISA or MSD platform to develop and validate methods for pharmacokinetic studies and anti-drug antibody studies.
* Familiarity with ICH M10 guidance is advantageous.
* Thorough understanding of GLP, GCP, and 21 CFR Part 11 regulations.
* Ability to work effectively in a team and independently.
* Excellent communication skills (writing and speaking).
* Knowledge and understanding of the pharmaceutical industry; CRO experience is desirable.
Benefits:
As a technical specialist, you will have the opportunity to lead assay development, deliver training, and drive best practice in our organization.
Present progress confidently to both internal and external stakeholders using various communication tools.
Highlight method development challenges and capture out-of-scope activities.
Support the SD/BPI by producing robust methods.
Collaborate with team members and the wider technical specialist group to share knowledge and expertise.
Maintain an interest in transferred methods and their progress through validation and sample analysis phases.
Troubleshoot as needed and contribute to meetings, sharing your knowledge within the team.
Ensure written records are to a high standard, regardless of GXP status.
Identify new technologies to expand our service offering.
Present technical/scientific content at internal meetings and actively mentor scientists.
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