Process Development & Manufacturing Specialist II - CDMO

Maravai LifeSciences; San Diego (CA); On-site; USD 80,000 - 85,000; Full time

Benefits offered by this job

RSU grants

Employee Stock Purchase Plan

Medical + HSA/FSA

Fertility assistance

Pet insurance

Retirement contributions

Paid time off

Job summary

Maravai LifeSciences is seeking a Process Development & Manufacturing Specialist II to produce research and clinical grade components and to set up, clean, operate and maintain lab equipment. You will document actions in batch records and SOPs, mentor colleagues, and lead technical transfers for new equipment.

The role requires hands-on experience with HPLC purification, oligonucleotide/mRNA processes, and cGMP guidelines, with strong communication and organizational skills.

Qualifications

• High school diploma or GED required; higher science degrees preferred.
• 5+ years of industry experience.
• Hands-on lab experience in HPLC purification, small molecule synthesis, oligonucleotide synthesis, or mRNA.
• Experience drafting, editing, and executing Standard Operating Procedures.
• Strong written and verbal communication; ability to mentor others.

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.
• 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 required.

Skills

HPLC purification

Small molecule synthesis

cGMP clean room

Oligonucleotide synthesis

mRNA

SOP drafting/editing

Written and verbal communication

Mentoring/training

Education

High school diploma or GED

Associate or Bachelor’s degree in science

Job description

Maravai LifeSciences is seeking a Process Development & Manufacturing Specialist II to produce research and clinical grade components and to set up, clean, operate and maintain lab equipment. You will document actions in batch records and SOPs, mentor colleagues, and lead technical transfers for new equipment.

The role requires hands-on experience with HPLC purification, oligonucleotide/mRNA processes, and cGMP guidelines, with strong communication and organizational skills.