Manufacturing Science and Technology Director

2 weeks ago


Petersburg, United States Sterling Life Sciences Full time
Job Opportunity: Manager of Manufacturing, Science and Technology

A challenging role exists for an experienced professional to lead the transfer of sterile biologics production processes and technologies from R&D into site operations. Our client, Sterling Life Sciences, is seeking someone who can bring added value to the team. Responsibilities include:

Key Responsibilities:
  • Develop and implement biologics process control strategy documents, technology transfer change controls, and engineering protocols in coordination with R&D.
  • Conduct process stewardship throughout the lifecycle management of commercial biologics manufacturing processes.
  • Design a Process Performance Qualification plan to demonstrate manufacturing process performance.
  • Oversee product technical lifecycle management, including process control strategy, process/yield improvement, and batch deviations.
  • Support product pre-approval inspection, including direct interaction with regulatory agencies.
  • Prepare and review cGMP documents, such as batch records, technical protocols, and reports.
  • Work with the Operations and Validation Team to prepare an aseptic core package for submissions.
  • Understand the scientific principles for manufacturing parenteral drug products, device assembly, and packaging.
  • Work with the Site Leadership Team to build subject matter expertise across functions.
  • Perform gap assessment for new product introduction and provide innovative solutions.
Critical Requirements:
  • A university degree is required, preferably in a relevant field.
  • Appropriate full-time work experience is mandatory.
  • Recent experience in the pharmaceutical industry is strongly preferred.
  • Preference will be given to candidates with recent experience in manufacturing management.


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