QC Specialist - Stability

We are currently looking for a QC Specialist - Stability to lead the management, design, tracking and reporting of stability studies. You will join a clinical-stage biotech organisation whose passion is to work together as one team and noticeably making life changing impact.

Job Responsibilities:

• Lead on all Drug Substance and Drug Product Stability studies with external CROs.
• Support the study designs to ensure all parameters for long term stability of product at appropriate storage conditions are covered.
• Review and input to study protocols.
• Track studies for key deliverables and method performance with CROs.
• Ensure timely testing in accordance with protocols and delivery of results, ensuring full review for data integrity.
• Review & input to CRO reports.
• Keep up to date with ICH and regulatory commitments concerning stability indication and reporting of GMO products.
• Manage acceptance criteria for stability studies across projects with oversight of related release specifications.
• Review sampling plans for stability assignment.
• Awareness of manufacturing schedules, planning, and forecasting related stability activities.
• Compile internal stability reports for projects as appropriate.
• Review and drive to closure all Quality events related to stability testing at CROs, documenting and assessing within the company's QMS system.
• Support accelerated studies and forced degradation studies with the Analytical Development team.
• Support direction of stability method development, and inclusion of stability indication in method qualification and validation studies (both CROs and internal workflow), in collaboration with AD & QC method SMEs.
• Monitor improvement initiatives for stability methods.
• Oversight of method transfers between CROs and the internal QC GMP team, related to ownership of stability testing.
• Any other assigned duties.

Requirements:

• At least 3-5 years working within GMP environment.
• Previous experience of designing and coordinating and delivering on product stability studies.
• Author and reviewing of QC / analytical study protocols and reports.
• Knowledge of ICH Stability guidelines.
• Management of CRO testing capabilities.
• Managed workflows and procedures supporting data integrity for reporting results.
• Authoring and / or reviewing of stability Regulatory CMC modules.
• BSc in Biochemistry or Biological Science.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.