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Careers >Scientist, Process Development

Description:

The Process Development Scientist will design novel synthetic processes and optimize existing processes for transfer to contract manufacturing organizations (CMO). This position will be responsible for producing compounds for evaluation in preclinical safety and efficacy studies. This includes preparation of representative materials for testing, impurities for reference, starting materials, intermediates, and the write-up of development reports and technology transfer packages for CMO.  This position reports to the Senior Manager of Chemical Development.
Specific duties include (but not limited to):

• Design and develop new routes and optimize existing processes, which includes the synthesis, purification and isolation of intermediates and bioactive lead compounds from milligram to multi-gram scales for use in R&D programs.
• Scale-up process to 100g+ to demonstrate process and trouble-shoot/facilitate implementation of manufacturing processes at CMOs, which include development and implementation of in-process controls.
• Perform preliminary solid form screening (e.g. polymorph, salt and co-crystal screening), and coordinate evaluation and selection of solid forms for lead compounds.
• Coordinate with Analytical, Medicinal Chemistry and QC to identify and characterize impurities in chemical processes, synthesize reference materials and deliver drug substances to project teams in a timely fashion.
• Prepare technology transfer packages for transfer to CMOs and development reports to support regulatory filings.
• Interact with/support technical staff of CMO to implement transferred process.

Requirements

Thorough experience in handling, synthesis, purification, and characterization of complex organic molecules using the latest techniques is required. Prior experience in a kilo lab or pilot plant setting, including a cGMP environment is highly desirable.

• BS with 10+, MS with 7+ or PhD or equivalent degree in organic chemistry or the chemical sciences with 3+ years working experience (postdoctoral may serve as experience)  with small molecule or peptide process development
• Strong and independent problem-solving and troubleshooting abilities
• Basic knowledge and understanding of cGMPs
• Preparative chromatography and LCMS experience a plus  
• Excellent oral and written communication skills
• Ability to work independently and in a team environment
• A flexible, “whatever it takes” attitude

Please send all inquiries to careers@proteolix.com. No agencies please.