mark allan

Managed QA release and status control for media and apheresis batches in CGT operations, ensuring final QA release within GMP timelines and coordinating cross‑functional investigations. Led a small QA specialist team and reviewed CAPAs, change controls, deviations and batch records using MES/SAP/LIMS.

Performed downstream processing for biosimilar monoclonal antibodies including buffer preparation (50–2000L), Protein A, viral inactivation, UF/DF and nanofiltration within GMP cleanrooms. Authored SOPs, supported CAPAs/deviations and used TrackWise/Veeva for quality records.

Operated aseptic production and fill/finish processes in Grade B/C cleanrooms, handling buffer preparation and sterile filtration for drug product manufacture under cGMP. Ensured sterile environments through validated cleaning and gowning procedures.

Prepared Investigator Site Files and pharmacy files and managed CTMS tracking for clinical trials, supporting CRAs and project teams while maintaining GCP compliance. Coordinated document control and administrative trial activities.

Operated aseptic prep and filling for injectable and freeze‑dried products in Grade A/B/C cleanrooms, managing batch reconciliation and sterility assurance under cGMP. Followed BMRs and SOPs to ensure product integrity and compliance.

Produced buffers and bacterial antigen materials for QC and customers in a GMP/GLP environment, managing batch records and using QPulse and Syspro for production control. Performed autoclave and centrifugation operations to support manufacturing.

Performed protein purification and buffer preparation in a cGMP laboratory producing CKS lysate, following QMS and SOPs to support manufacturing operations. Maintained documentation and compliance within the quality management system.

Bachelor of Science in Biological Sciences, completed June 2013, covering core biological concepts and laboratory techniques relevant to biopharma.