Senior Manufacturing Science and Technology

4 weeks ago

Fishers, Indiana, United States INCOG BioPharma Full time

The Senior Manufacturing Science and Technology (MSAT) Engineer will be responsible for supporting all facets of Tech transfer, Process Validation, GMP Floor Support, and Continued Process Verification.

This role will provide strong technical oversight to the production to ensure robust and reliable production processes are established.

This position holds the responsibility of delivering substantial technical guidance and supervision throughout the production process.

The primary objective is to establish production processes that are not only robust and reliable but also capable of consistently delivering high-quality products.

This entails overseeing the various stages of production, identifying potential areas for improvement, and implementing measures to enhance the overall efficiency and effectiveness of the production operations.

MSAT Engineer is responsible for the execution of early packaging development activities in a cross-functional team and requires pharmaceutical packaging and combination product development knowledge.

You will be responsible for the development of primary, secondary, and tertiary packaging while managing due dates and project timelines from clinical to commercialization.

Key Responsibilities:

  • A solid understanding of packaging materials and manufacturing processes and experience in global packaging standards for pharmaceutical drug products, parenteral container-closure systems, and combination products is required.
  • Leads technical troubleshooting and investigations of packaging issues to support root cause analysis, product impact assessment and effective corrective and preventive actions.
  • Provide technical guidance and oversight to Operations and Validation group to support Process Performance Qualification and Continuous Process Verification.
  • Provide technical expertise for developing packaging/labeling material selection, qualification, and process implementation for new product programs.
  • Author and review of regulatory information packages and filings/submissions.
  • Represents MSAT in project teams and communicates directly with customers. Help authoring GMP manufacturing documentation including Master Batch Records, Bill of Materials and Processing Forms.
  • Monitor Process Data, identify trends and propose actions as necessary.

Requirements:

  • Bachelor's degree in science, engineering or packaging technology.
  • Master's degree in science, engineering or packaging technology preferred.
  • Demonstrated experience in the field of pharmaceutical packaging or combination product development and commercialization.
  • Experience in global product launches and the associated CMC regulatory requirements.
  • Experience in Technical Transfer for pharmaceutical or related industry.

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