Process Development & Manufacturing Specialist II, CDMO

TriLink BioTechnologies • San Diego, CA

5d • $80,000 - $85,000 • Onsite

About The Position

Maravai LifeSciences is seeking a Process Development & Manufacturing Specialist II to join their customer development team. This role involves producing research and clinical grade components and products by 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. The position requires adherence to Good Documentation Practices and involves acting as a subject matter expert, providing leadership, mentoring, and training in the laboratory.

Requirements

• High school diploma or GED required
• 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

Nice To Haves

• Associate or Bachelor’s degree preferred (Science)

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 required

Benefits

• Potential to change, improve, and save lives around the world
• Opportunity to be a part owner in Maravai through RSU grants and optional employee stock purchase plans
• Comprehensive medical plans and HSA/FSA options
• Fertility & family planning assistance
• A 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: High school or GED