Process Development & Manufacturing Specialist II, CDMO

Maravai LifeSciences • San Diego, CA

5d • Onsite

About The Position

Maravai LifeSciences is seeking a Process Development & Manufacturing Specialist II to join their customer development team. In this role, you will be responsible for producing research and clinical grade components and products. This involves setting up, cleaning, operating, and maintaining equipment, performing wet chemistry reactions, utilizing pilot grade purification systems, authoring and implementing SOPs, and documenting actions in batch records according to Good Documentation Practices. This position also serves as a subject matter expert, providing leadership, mentoring, and training to new team members in the laboratory.

Requirements

• High school diploma or GED
• Associate or Bachelor’s degree preferred (Science)
• 5+ years of industry experience
• Hands on laboratory experience in areas such as HPLC purification and/or small molecule synthesis, cGMP clean room, oligonucleotide synthesis, mRNA
• Experience with drafting, editing, implementing and executing Standard Operating Procedures
• Strong written and verbal skills
• Self-motivated and able to organize and prioritize multiple tasks
• Ability to mentor other team members on processes they have become proficient at executing

Responsibilities

• Produces research and clinical grade components and products
• Prepares for production by reviewing production schedule; studying and clarifying specifications; calculating requirements; assembling materials and supplies
• Maintains safe and clean work environment by following standard operating procedures
• Writes and executes batch records, author and review SOPs, and maintain quality documents associated with manufacturing
• Keeps equipment operating by following operating instructions; troubleshooting breakdowns; calling all repairs
• Documents production by accurately completing forms, reports, logs, and records of equipment and batches following good documentation practices
• Trains and mentors new team members
• Onboards and authors procedures for new equipment
• May collect, records and analyze data
• Interprets key process bottlenecks and implements process improvements to minimize bottleneck
• Performs characterization assays centered around developmental improvements
• Transfers developmental improvements to manufacturing team through training/technical transfer
• Perform other functions and duties as assigned

Benefits

• Company equity (RSU grants)
• Optional employee stock purchase plans
• Comprehensive medical plans
• HSA/FSA options
• Fertility & family planning assistance
• Variety of additional optional benefits and insurance options, including pet insurance
• Retirement contributions
• Holidays & Paid Time Off

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree