Senior Scientist /Associate Scientist

Basic qualifications:

Bachelor degree in Chemical Engineering, Biology, Chemistry, or other engineering or scientific field

Preferred qualifications:

1+ year(s) of direct GMP manufacturing experience or purification experience

  • Thorough knowledge of Good Manufacturing Practices (GMP) regulations
  • Thorough knowledge of routine laboratory/plant equipment and demonstrates high level of technical expertise with working familiarity with a number of methods, techniques, laboratory procedures and processes
  • Possess in-depth knowledge of how to analyze and interpret experimental/process data
  • Demonstrated ability to work as self-starter and handle multiple priorities in a dynamic cross-functional team based environment
  • Experience with GE platform of purification equipment and Unicorn software


Job Description:

The Associate Scientist leads the manufacture of clinical supply of investigational biopharmaceutical molecules. Specifically, hands-on cGMP mid to large scale purification of bulk drug substance for use in early phase clinical trials.

Key responsibilities include:

  • Performs hands-on processing of large scale purification steps under cGMP regulatory conditions. Processing steps include: Column packing, Chromatography, UltraFiltration/DiaFiltration, Depth Filtration, Bulk Drug Fill
  • Completes activities requiring independent thought that have the potential to comprise 50-100% of the employee's time depending on production campaigns
  • Leads or works on projects and assignments where independent action and a high degree of initiative and knowledge are required for execution or to provide recommendations
  • Supports the technology transfer process through active participation in ensuring that new processes fit and execute consistently
  • Manages daily activities within the area, including personnel efforts
  • Serves as floor lead during preparation and processing activities and potentially as area Supervisor, in the absence of the Supervisor
  • May be required to perform cleaning/sanitization of equipment and associated parts utilizing equipment washers, Clean-In-Place (CIP) systems as well as manual cleaning methods, on as-needed basis
  • May be required to prepares, assembles and sterilizes via autoclave of equipment and process components, on as-needed basis
  • May be required to prepare buffers, including weigh and dispense, formulation, and filtration activities, on as-needed basis

Specific Duties include:

  • Executes and overseas production of clinical supplies based on established scientific procedures and protocols and implements improvements with minimal supervision; interprets data and draws conclusions from the data
  • Anticipates/recognizes potential problems with equipment and/or supplies, and proactively seeks input from other Scientists to takes action to solve or prevent problems
  • Recognizes potential safety and compliance problems and takes action to rectify
  • Troubleshoots problems in the execution of processing activities; proactively assesses options and impact and takes action to rectify or communicate to appropriate decision makers
  • Authors Standard Operating Procedures (SOPs), Investigation reports, Safety Assessments, and various other protocols with minimal supervision
  • Reviews and approves executed load documentation (washer and autoclave), Buffer Forms, and/or Batch Records prior to submission to Quality Assurance (QA) to insure adherence to cGMPs and proper documentation practices

Contact information:

You may apply for this position online by selecting the Apply now button.

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