Immunomedics, Inc.

Director, MSAT

Job Locations US-NJ-Morris Plains
Posted Date 3 months ago(1/8/2020 12:03 PM)
Job ID
2020-1611
# of Openings
1
Category
Other

Overview

The Director, MSAT will be the technical and leadership resource for the MSAT department, purposed to provide engineering and scientific expertise to tech transfer, process scale-up, equipment and process optimization, technical document authoring, continuous improvement, equipment and process quality system ownership, and on-the-floor mentorship for all large-scale processing. 

Responsibilities

  • Lead a multi-functional team of engineers and/or scientists to ensure robust tech transfer and process scale-up
  • Serves as the large-scale process expert, utilizing technical and engineering tools to troubleshoot and/or optimize the process.
  • Manages the team in analyzing data and creating trending grafts and reports. Conducts routine data trending meetings and discussions with cross functional teams. Trouble shoots and resolves process issues.
  • Manages the team to serve as a technical resource and SME for large-scale process projects and activities.
  • Takes ownership of all process-based quality systems, including change controls, deviations, and CAPAs. Work with Manufacturing, Process Sciences, and QA to properly manage quality system investigation and closure.
  • Authors technical documents, including but not limited to Tech Transfer protocols, DOE protocols, Campaign summary reports, Process data reports, and CMC sections as appropriate.
  • Manages the team to improve process throughput, utilizes modeling tools to identify bottlenecks and improve throughput.
  • Manages the team to serve as on-the floor experts for all process runs as directed by the Manufacturing Management.
  • Manages the team to assist with SOP and MBR improvements.
  • Manages the team to implement process improvements.
  • Direct Reports (Engineers, Scientists, Project Managers)

Qualifications

  • BS in appropriate science discipline with at least 10 years of industry experience and a minimum of 6 years in a leadership role at a regulated facility. Additional and equal relevant experience in lieu of formal education will be considered.
  • Experience leading teams in planning and execution of technical related activities.
  • Experience with writing and reviewing appropriate CMC sections
  • Experience in startup and scaleup activities in support of Phase 3 Clinical and Commercial Manufacturing.
  • Direct experience with regulatory agencies.
  • Strong technical writing experience.
  • Experience in process modeling to scale
  • Excellent technical and analytical skills.
  • Thorough knowledge of Upstream, Downstream.
  • Single-Use technology experience is highly preferred
  • Must possess excellent communication (oral and written), organizational, and interpersonal skills.
  • Strong understanding of cross-functional leadership, decision-making, and influence.
  • Comfortable with respectfully challenging convention.
  • Ability to manage up, down, and across levels and departments.
  • Must have ability to work in fast paced environment with an in-process infrastructure
  • Experience with staff performance evaluation and management, succession/progression planning, and improvement planning.
  • Project Management expertise is a plus.

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