Scientist, Organic Synthesis

Responsibilities

• Contribute to process development, optimization, and scale-up of speciality starting materials
• Support the process and product characterization of small molecules and oligonucleotide APIs
• Contribute to the management and optimization of in-house and contract manufacturing processes
• Author and review technical protocols and development reports in support of manufacturing and process characterization activities for CTA filing
• Author, edit, and review manufacturing documentation according to regulatory and procedural guidelines
• Support RA activities with authoring starting materials related
• Work closely with analytical development, manufacturing technical operations, QA, QC, supply chain, Regulatory Affairs and CMO/CRO on the process transfer and process optimization
• Contribute to strategic technical discussions and presenting progress at internal and external scientific meetings

Qualifications

• Ph.D. in chemistry, chemical engineering, or biochemical engineering or B.S./M.S. with 7+ years of relevant experience
• Process research and development experience in organic synthesis
• Demonstrated proficiency in the design and development of practical processes for manufacture of small molecules, peptides and oligonucleotides
• Hands-on experience in process development and analytical methods for process and product characterization
• Excellent interpersonnel, organizational and communication skills
• Demonstrated strong operational execution and problem-solving skills
• Desire to work in a fast-paced, deadline-driven work environment