Senior Process Development Specialist

TriLink BioTechnologies • San Diego, CA

2d • Onsite

About The Position

Maravai LifeSciences is seeking a #MiracleMaker to join our custom development team as a Senior Process Development Specialist . 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 .

Requirements

• Minimum a Bachelor’s of Science in chemistry related field.
• 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.

Responsibilities

• Maintains safe and clean work environment.
• Keeps equipment operating by following operating instructions; troubleshooting breakdowns; calling for repairs.
• Identifies bottle necks/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

Benefits

• You have the potential to change, improve , and save lives around the world.
• You have the opportunity to be a part o wner in Maravai through RSU grants and optional employee stock purchase plans .
• We offer comprehensive medical plans and H SA /FSA options .
• Fertility & family planning assistance .
• A variety of additional optional benefit s and insurance options, including pet insurance.
• Retirement contributions .
• Holidays & Paid Time Off .

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level