As a QC Staff Scientist in Biochemistry you would participate in assay development, transfer, and validation for QC. You would provide technical support, guidance and supervision for release, stability, and in-process testing and assay development/validation and/or transfer.
In this role a typical day might include, but is not limited to, the following:
* Participating in assay development/validation for QC
* Reviewing and approving new test procedures and assays
* Evaluating new methodologies, techniques and equipment when new procedures are warranted
* Participating in transfer of methodology from R&D
* Generating and/or supporting completion of compliance records, CAPAs, change controls and deviation notifications as needed
* Evaluating assay performance through yearly method performance reports
* Facilitating assay transfer from R&D and to business partners
* Providing technical input into additional studies supporting regulatory filing e.g. Bridging/comparability studies
* Participating in technical troubleshooting and problem investigation
* Reviewing analytical development report, assay and process validation report and other technical documents for technical correctness and regulatory compliance
* Participating in training programs for Analysts
* Supporting and participating in regulatory inspections
* Participating in cross-functional improvement initiatives/kaizens
* Participating in data review for technical correctness and regulatory compliance
* Bringing new technologies and techniques into QC
* Assisting in writing technical sections of regulatory submissions
To be considered for this opportunity you should hold a PhD in Biochemistry, Chemistry, Biology or related field and 5+ years of experience, preferably in the pharmaceutical or biotechnology industries or MSc with 9+ years of experience, preferably in the pharmaceutical or biotechnology industries.
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