Services

Compliance Projects

 

  • Completed Quality by Design documentation for injectable consulting client: Critical Quality Attributes (CQA) Determination, CQAs vs Unit Operations, and Risk Assessment using pFMEA.

  • Wrote Divisional document re-writes for qualification documents to harmonize with external guidance documents and Corporate policies.

  • Project manager for CAPA project relating to product launch and equipment issues.

  • Product defect CAPA project and CAPA document re-write for consulting client.

  • EU Annex 15 toxicology project for consulting client. 

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:

  •  Cell culture and down stream processing equipment, including:

    • Yeast and E. coli fermentation

    • Mammalian cell tissue culture in roller bottle, hollow fiber and bioreactors.

    • Tangential flow filtration

    • Homogenization

  • Continuous flow centrifuge, ultra centrifuges, and centrifuge biohazard containment glove boxes.

 

Managed the design team, installation, and qualification of:

  • Complex Biohazard Level 3 facility renovation and qualification.

  • Utilities:  distilled water, compressed air, and nitrogen.

  • Walk-in coolers, freezers and incubators.

Facilities, Utilities and Equipment Qualification

 

Authored potocols, executed and wrote reports for:

  • Laboratory equipment

  • Tangential Flow Filtration, homogenizer, Clean In Place, ovens, glasswashers, autoclaves and vapor phase hydrogen peroxide decontamination units. 

  • 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

 

  • Authored validation master plan procedure.

  • Managed Process Validation team leaders working on Plasma Recalcification, Plasma Heat Inactivation, Dialysis/Diafiltration, and Mixing processes through process and test method characterization. 

  • Co-managed mixing process validation team through process validation completion, FDA summary and certification by FDA. 
     

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