Senior Process Development Specialist

Role Summary

The Senior Process Development Specialist will support the transfers of new processes to produce GMP grade oligonucleotides; performing wet chemistry reactions; development work on synthesis, deprotection, purification, salt exchange procedures and in process QC; writes and updates SOPs and work instructions; onboards and trains new technicians. Leads, coordinates and performs process improvement and scale up projects.

Responsibilities

• Maintains safe and clean work environment.
• Keeps equipment operating by following operating instructions; troubleshooting breakdowns; calling for repairs.
• Identifies bottlenecks/process deficiencies and develops and executes projects for improvements.
• Troubleshoots and provides technical assistance with problematic oligo sequences.
• Documents work by accurately completing forms, reports, logs, and records of equipment and batches following good documentation practices.
• Collects, records and analyzes data.
• Interprets data analysis results and draws inferences and conclusions.
• Plans, develops, organizes, writes and edits operational procedures and GMP batch records.
• Initiates projects based on process improvements and scale up.
• Initiates characterization assays centered around developmental improvements.
• Onboards and authors procedures for new equipment and procedures.
• Transfers developmental improvements to manufacturing team through training/technical transfer.
• Oversees training of new processes for GMP manufacturing staff.
• Perform other functions and duties as required.

Qualifications

• At least 5 years of relevant manufacturing laboratory experience, HPLC purification, Oligo synthesis, and scale up.
• Experience in GMP Manufacturing following ICH Q7 guidelines in an ISO 7 and/or ISO 8 clean room.
• Experience with Standard Operating Procedures.
• Strong written and verbal skills.
• Self-motivated and able to organize and prioritize multiple tasks.
• Experience in compiling, analyzing and presenting technical data.

Education

• Bachelor’s of Science in chemistry related field.