Senior Process Development Specialist

Maravai LifeSciences • San Diego, CA

2d • Onsite

About The Position

Maravai LifeSciences translates extraordinary science into everyday miracles, helping biotech, biopharma, and life sciences companies everywhere deliver novel vaccines, therapeutics, and diagnostics. We are global leaders in providing products and services within the fields of nucleic acid production and biologics safety testing to many of the world's leading biopharma, vaccine, diagnostics, and cell and gene therapy companies. At Maravai, we believe that diverse perspectives are the foundation of innovation. Through an inclusive and equitable culture where every team member is inspired to bring their best selves to work, we cultivate an environment in which we can lead together, providing differentiated value to our customers, and enabling the miracles of science. For over 35 years, Maravai’s portfolio companies have served as a catalyst for innovative, lifesaving technology for humanity. Pioneering nucleotide research since its inception , we are now leading the way in the rapidly expanding mRNA market . Your next role as a Miracle Maker 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