Associate Director - Manufacturing Strategy & Operations
Expanded responsibilities including suspension LVV manufacturing. Provided meaningful and actionable feedback and training for team member growth and development.
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Anna Eg Stager is listed as MS in Biomedical Sciences based in Lancaster, Pennsylvania, United States. AeroLeads shows a matched LinkedIn profile for Anna Eg Stager.
Anna Eg Stager previously worked as Associate Director - Manufacturing Strategy & Operations at Bluebird Bio and Principal Process Engineer at Bluebird Bio. Anna Eg Stager holds Master’S Degree, Biomedical Sciences from Colorado State University.
Anna Eg Stager is a MS in Biomedical Sciences. They is proficient in Spanish.
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Somerville, Massachusetts, Us
Expanded responsibilities including suspension LVV manufacturing. Provided meaningful and actionable feedback and training for team member growth and development.
Somerville, Massachusetts, Us
MSAT lead supporting biological starting material and Lenti-viral vector (LVV) commercial manufacturing operations at CMO partners for multiple products; included MCB/WCB generation as well as end-to-end plasmid and LVV manufacturing utilizing adherent cell culture. Principal investigator of complex process performance and product quality excursions, maintaining critical patient supply. Quality document owner for continuous process validation (CPV) and process change coordinator managing PPQ requirements and regulatory submissions.
Somerset, Nj, Us
Served as CMO MSAT lead for the tech transfer of clinical Adeno-associated virus (AAV) cell and gene therapy products from process development to GMP manufacturing for suspension and adherent cell culture, harvest, purification, and fill finish unit operations. Authored technical documents including process descriptions, sampling plans, master production records, etc. in support of end-to-end manufacturing operations. Lead New Product Introduction (NPI) process including risk assessments and change controls/actions. Facilitated interdepartmental collaboration with client representatives, PD, QA, QC, and Manufacturing to develop GMP and US/EU quality compliant processes. Worked closely with materials procurement representatives to develop project-specific BOMs, generate material and final product specifications, and secure consumables.
Somerset, Nj, Us
Directly oversaw and managed the CDMO production activities and staff for multiples upstream manufacturing suites for the Catalent BioPark site. Projects included Engineering runs, Phase I/II GMP AAV gene therapy production, and MCB/WCB generation. Provided on-the-floor supervision for single-use upstream production activities utilizing the following processes: flask scale up, WAVE bioreactors, 200L Sartorius STR bioreactors, AAV transfection, pod depth filtration, clarification, and hollow fiber tangential flow filtration (TFF) for bulk drug substance concentration and diafiltration.
Cambridge, Cambridgeshire, Gb
Execution of large-scale monoclonal antibody (mAb) upstream manufacturing; including, but not limited to, aseptic operations in a biological safety cabinet, media and stock solution preparation, WAVE bioreactors, 100L – 15,000L stainless steel bioreactors, large-scale centrifugation, and pod/depth filtration systems. Primary site trainer for aseptic operations and ISO gowning certification, specifically ISO 7 and 5. Assisted in start-up qualification activities (IQ, OQ, and PQ) for stainless equipment. Additionally, performed CIP/SIP development and validation work.
Fort Collins, Colorado, Us
Manufactured biopharmaceutical products for pre-clinical development and clinical use under Biosafety Level 3 (BSL-3) and BSL-2 containment and Select Agent (SA) biosecurity conditions. CDMO projects included viral vaccine and bio-therapeutics process development and manufacturing. Followed cGMP regulations and FDA Guidance in the creation of controlled documents including MPR/BPR's, SOP’s, job aids, and other directive documents for cell culture, sampling methods, and equipment use. Technically specialized in upstream adherent and suspension aseptic mammalian cell culture utilizing T-flasks, shake flasks, single-use WAVE and 200L Sartorius Bioreactors, microcarriers, and Corning HYPERflask/HYPERstack systems. Exposed to mid/downstream electroporation, clarification, small-scale column chromatography, formulation, and filling.
Lancaster, Pa, Us
Chemist for a leading contract lab providing testing and research services in the environmental, pharmaceutical, and biopharmaceutical sciences to clients worldwide. Performed variety of organic extractions to isolate semi-volatile contaminants, polychlorinated biphenyls (PCBs), as well as herbicides and pesticides in accordance to GLP, GDP, and standardized SOP’s.
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Anna Eg Stager is listed as MS in Biomedical Sciences.
Anna Eg Stager is based in Lancaster, Pennsylvania, United States.
Anna Eg Stager has worked for Bluebird Bio, Catalent Pharma Solutions, Astrazeneca, Biomarc, and Eurofins Lancaster Laboratories.
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Anna Eg Stager holds Master’S Degree, Biomedical Sciences from Colorado State University.
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