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Mark Erickson Head Shot Photo C14A9814-Exposure_edited_edited.jpg

Mark is a high-impact pharmaceutical manufacturing leader with over eighteen years of Manufacturing Operations and Process Development experience. Thorough understanding of business at all stages from Drug Substance bulk processing to Drug Product final dosage manufacturing. Chosen as Leader for significant New Product Introductions and Technology Transfer abilities. Consistently builds new capabilities to deliver organization's strategic objectives during periods of transformation. A respected, trustworthy, and innovative team player.


  • Extensive background within single use manufacturing platforms and vendor capabilities.

  • Extensive background in final drug product visual inspection (Acceptance Sampling Plans, Visual Inspection qualification).

  • Guided the development of Werum PAS-X MES manufacturing documents supporting ATARA Bio electronic batch records.

  • Participate in development of Quality Systems (Deviation, Change Management, CAPA, etc.) as manufacturing business owner.

  • Collaborate with manufacturing partners (Process Development, Supply Chain, Engineering, Quality) to develop processes and systems that enable compliant, successful technology transfers, operation, and lifecycle management of cGMP clinical manufacturing processes.

  • Create programs to lead investigations as function of quality management systems to support MFG.

  • Facilitate risk management and scenario planning programs for internal manufacturing operations.

  • Lead and participate in the design, development, and qualification of manufacturing execution systems, equipment, and systems.

  • Lead projects within the manufacturing team in support of clinical operations readiness.

  • Lead training, mentoring, general manufacturing readiness, and performance metrics programs for MFG.

  • Support operations (Technical, Quality, Supply Chain, Manufacturing) activities associated with the planning, manufacture, and delivery of products.

  • Drive timely decisions and facilitate active communication and information flow to senior management.

  • Utilize strong working knowledge of cGMP processes along with knowledge of regulatory compliance requirements to support plant inspection-readiness.

  • Lead project deliverables using project management principles in preparation for routine manufacturing.

  • Author technical documents for regulatory agency submission in support of manufacturing processes.

  • Extensive background across multiple SQM platforms (TrackWise, Veeva Vault, ZenQMS).

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