Oral solid dosage drugs
blood diagnostic testing
sterile manufacturing environment
Oral solid dosage drugs
Services
Compliance Projects
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Completed Quality by Design documentation for injectable consulting client: Critical Quality Attributes (CQA) Determination, CQAs vs Unit Operations, and Risk Assessment using pFMEA.
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Wrote Divisional document re-writes for qualification documents to harmonize with external guidance documents and Corporate policies.
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Project manager for CAPA project relating to product launch and equipment issues.
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Product defect CAPA project and CAPA document re-write for consulting client.
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EU Annex 15 toxicology project for consulting client.
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Project Management
Management of compliance projects:
CAPAs, Quality by Design documentation, gap analysis and remediation, document harmonization and re-writes, Capital, Process and Facility and Qualification projects.
Process Engineering
Designed, purchased, installed and qualified:
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Cell culture and down stream processing equipment, including:
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Yeast and E. coli fermentation
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Mammalian cell tissue culture in roller bottle, hollow fiber and bioreactors.
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Tangential flow filtration
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Homogenization
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Continuous flow centrifuge, ultra centrifuges, and centrifuge biohazard containment glove boxes.
Managed the design team, installation, and qualification of:
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Complex Biohazard Level 3 facility renovation and qualification.
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Utilities: distilled water, compressed air, and nitrogen.
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Walk-in coolers, freezers and incubators.
Facilities, Utilities and Equipment Qualification
Authored potocols, executed and wrote reports for:
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Laboratory equipment
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Tangential Flow Filtration, homogenizer, Clean In Place, ovens, glasswashers, autoclaves and vapor phase hydrogen peroxide decontamination units.
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Refrigerators, freezers, ovens and incubators ( both stand alone and walk in units).
- Bioreactors, fermentors, vessels, and biohazardous kill tanks.
- Continuous flow centrifuge, ultra centrifuges and centrifuge glove boxes for biohazardous applications.
Process Validation
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Authored validation master plan procedure.
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Managed Process Validation team leaders working on Plasma Recalcification, Plasma Heat Inactivation, Dialysis/Diafiltration, and Mixing processes through process and test method characterization.
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Co-managed mixing process validation team through process validation completion, FDA summary and certification by FDA.