Scientist II, Process Development

2 weeks ago


Lakewood New Jersey, United States Renaissance Lakewood LLC Full time
Job Summary

Renaissance Lakewood LLC is seeking a highly skilled Scientist II to support the development and optimization of manufacturing processes. The ideal candidate will have a strong background in scientific principles and theories, with experience in process development and optimization.

Key Responsibilities
  • Design and conduct experiments at small and medium scales in coordination with the R&D group.
  • Collect and analyze data from development batches and provide process development reports and tech transfer reports.
  • Provide input in developing robust process validation programs.
  • Perform risk assessment and present ideas for modifying existing procedures and suggest alternative methods to improve results.
  • Understand, keep current, and apply current technology to include cGMP, sterile manufacturing techniques.
  • Collaborate with Engineering, Operations, OpEx, and QA groups and prepare robust manufacturing records, technical reports, and SOPs.
  • Use statistical process control and other statistical tools for comparison and hypothesis testing.
  • Apply engineering, pharmaceutical sciences, or materials sciences fundamentals to model the product and process to solve complex technical problems.
  • Provide technical expertise to resolve challenges associated with full-scale commercial production.
  • Work in the aseptic compounding and filling processes and assist in maintaining the equipment used for production.
  • Train and mentor new employees within the department.
  • Work closely with internal and external departments to ensure the efficient progress of projects.
Requirements
  • Bachelor's Degree (BS) in Engineering or Natural Sciences required with a minimum of 3 years of relevant experience in the pharmaceutical industry or equivalent combination of education and experience.
  • Experience with API, small molecule is preferred.
Working Environment

The ideal candidate will be able to work in a fast-paced environment and collaborate with cross-functional teams to achieve project goals. Renaissance Lakewood LLC is an equal opportunity employer and welcomes applications from diverse candidates.


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