Temp QC Technical Resources Specialist

Within this role you will support lifecycle management within the QC Technical Resources group. You will participate (Perform, Review, Co-ordinate) in assay development, characterization, optimization, transfer, validation and investigation for QC group. You may provide technical support, guidance and supervision for release, stability, and in-process testing and assay development as a subject matter expert (SME).

This is a 12-month contract.

As a Temp QC Technical Resources Specialist, a typical day might include, but is not limited to, the following:

Collaborating with Analytical Sciences (AS) to integrate methods into QC Commercial evaluating and selecting suitable methods prior to process validation

Monitoring and analyze daily method performance in the QC lab, coordinating with subject matter experts for problem resolution as needed

Liaising with Regulatory Sciences and External Manufacturing to manage timelines for method validation and transfers, communicating updates to management

Monitoring method updates, performance, and quality metrics, ensuring consistent harmonization and performance evaluations across multiple sites

Coordinating post-transfer investigations and multi-site trending, escalating issues to management when necessary

Driving process improvements and support investigational analysis, performing and coordinating assay qualifications and transfers

Developing and drafting new test procedures and assays, authoring technical documents like Analytical Development and Validation Reports

Participating in training programs for QC personnel, ensuring all activities align with project timelines and deliverables

This role may be for you if you have:

The ability to work independently or as part of a team

Strong skills in planning, critical thinking and problem-solving, ability to follow directions and perform well-defined tasks

Excellent written and oral communication skills

The ability to develop strategy and create metrics to measure effectiveness of strategy

To be considered for this opportunity you should have a BS/BA in a life sciences field and 2 years of experience or equivalent combination of education and experience.

Education and Experience:

Scientist level minimum 2 years of experience

Sr Scientist level minimum 5+ years of experience