Astellas Pharma US

Purpose:

This individual will be responsible for process development activities of drug product for clinical phased development programs at AIRM. This position will collaborate closely with various departments including Process Science Technology, Analytical Development, Regulatory Affairs, cGMP Manufacturing, Quality Control and Quality Assurance. The DPD Scientist will manage and execute studies required to establish manufacturing processes of drug product including scale up aiming for commercialization. He or she will also be expected to proactively contribute to creative solutions for streamlining integrated development plans and to manage risk.

 

Essential Job Responsibilities:

  • Takes a leadership role in process and formulation development of cell based drug products.
  • Implement scale-up of parenteral drug product processes.
  • Manage and implement planning and execution of incorporation appropriate processing materials, and equipment to suit regulatory requirements.
  • Direct/conduct studies, summarize the data and prepare study reports.
  • Collaborate with mechanical vendors to establish new processes.
  • Supervise and/or participate in pilot production and technology transfer to CMO (Contracted Manufacturing Organization).
  • Assist in writing CMC regulatory amendments and filings
  • Cross functional collaboration with colleagues for process optimization leading to increased manufacturing efficiencies, quality, and yields of drug product.
  • Lead the formulation development to ensure timely project delivery.
  • Resolve technical and workflow issues in a timely fashion.

Requirements

Qualifications:

Required

  • PhD with 3+ years’ experience; MS with 7 + years’ experience; Bachelors with 8 + years’ experience in life sciences with experience in cell handling, aseptic processing, relevant techniques
  • Experiences of process development of cell based drug product.
  • Experience in development of parenteral drug product such as formulation development and aseptic filling (or auto-filling) process.

 

Preferred

  • PhD preferred
  • 3+ years of industrial experiences of process development of cell product such as scaling up
  • 2+ years of experience in GMP/GLP environment.
  • Working knowledge of ocular cells, bioreactors and down-stream mammalian scale-up experience.
  • Experiences of PV (Process Validation) or PPQ (Process Performance Qualification) of drug product.
  • Experiences of IND, BLA and/or NDA.

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Equal Opportunity Employer Minorities/Women/Protected Veterans/DisabledType Full-timeLocation MA, MarlboroughCategory Research and Development

To apply for this job please visit astellascareers.jobs.