Sr. Process Chemist PET Drug Technology and Process Development

Lantheus Medical Imaging-posted 6 months ago
Springfield Township, NJ
Merchant Wholesalers, Nondurable Goods
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The Senior process chemist will be responsible for supporting commercial and late-stage (phase 3) clinical products internally and to third party contract manufacturing organizations (CMOs) in the field of Positron Emission Tomography (PET) diagnostic imaging drugs and radioligand therapeutic drugs. Working cross functionally the role will be accountable for the technology support, process development, process improvement and transfer processes including planning, process scale-up and development studies, gap assessments, and equipment / process qualification. Following commercialization of finished products, the role responsible for managing improvement projects and supporting evaluation and resolution of technical and quality issues to ensure supply of commercial products in the Manufacturing Technology and Development (MT&D) organization at Lantheus.

  • Design and conduct process studies for clinical and commercial PET drug MFG process development.
  • Critically evaluate data, determine appropriate conclusions and a plan of action in collaboration with internal and external stakeholders to develop GMP production processes.
  • Provide project data and progress status updates to management.
  • Work with cross-functional teams on the development of synthesis, purification, formulation and aseptic filling processes, including process transfer, scale-up, validation and launch activities.
  • Support the preparation and review of written procedures, batch records, experimental protocols and reports, specifications and qualification/validation protocols.
  • Prepare technical reports and documents, including SOPs and investigational reports.
  • Conduct work according to best practices and, where appropriate, regulatory guidance, GMPs, established business processes and protocols, and applicable standard operating procedures.
  • Coordinate complex projects to meet established timelines without impacting manufacturing. Proactively adjust schedules to meet changing priorities.
  • Manage Technical Transfer to CMOs or on-site process and material qualifications. Write and execute validation protocols either acting as the study director/validation engineer or working with the Validation department.
  • Lead and participate in investigations to drive technically and scientifically sound corrective and preventative actions. Apply creative problem-solving techniques using knowledge base and historical experience to address immediate, short-term and future needs.
  • Lead root-cause analysis investigations as a technical resource.
  • Present data and information as a technical subject matter expert to regulatory agencies.
  • Actively promote safety. Always demonstrate good safety practices including the appropriate use of protective equipment. Report and take initiative to correct safety & environmental hazards.
  • Actively demonstrate the Lantheus values.
  • Write and manage actions for change controls in Quality Management System (QMS) as applicable for tech transfers.
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