Process Development & Manufacturing Specialist II, CDMO
Maravai LifeSciences
11 days ago
On-site
San Diego, CA
Operations
Process Development & Manufacturing Specialist II
Responsibilities:
- Produce research and clinical grade components and products by setting up, cleaning, operating, and maintaining equipment; performing wet chemistry reactions; and utilizing pilot grade purification systems
- Author, implement, and execute SOPs; write and execute batch records; maintain quality documents
- Prepare for production by reviewing production schedules, clarifying specifications, calculating requirements, and assembling materials/supplies
- Maintain a safe and clean work environment by following standard operating procedures
- Keep equipment operating by following operating instructions; troubleshoot breakdowns and call for repairs
- Document production accurately in forms, reports, logs, and batch/equipment records using Good Documentation Practices
- Train and mentor new team members; onboard and author procedures for new equipment
- May collect, record, and analyze data; interpret process bottlenecks and implement process improvements
- Perform characterization assays and transfer developmental improvements to manufacturing via training/technical transfer
Qualifications/Skills:
- High school diploma or GED required; Associate or Bachelor’s degree preferred (Science)
- 5+ years of industry experience
- Hands-on lab experience (e.g., HPLC purification and/or small molecule synthesis, cGMP clean room, oligonucleotide synthesis, mRNA)
- Experience drafting/editing/implementing/executing Standard Operating Procedures
- Strong written and verbal skills; self-motivated with ability to organize/prioritize multiple tasks
- Ability to mentor others on processes
Benefits (explicitly stated): RSU grants/employee stock purchase plans; comprehensive medical plans with HSA/FSA; fertility & family planning assistance; optional benefits/insurance (including pet insurance); retirement contributions; holidays & paid time off.
Application instructions:
- Visit https://www.maravai.com/careers/ for more opportunities.
Responsibilities:
- Produce research and clinical grade components and products by setting up, cleaning, operating, and maintaining equipment; performing wet chemistry reactions; and utilizing pilot grade purification systems
- Author, implement, and execute SOPs; write and execute batch records; maintain quality documents
- Prepare for production by reviewing production schedules, clarifying specifications, calculating requirements, and assembling materials/supplies
- Maintain a safe and clean work environment by following standard operating procedures
- Keep equipment operating by following operating instructions; troubleshoot breakdowns and call for repairs
- Document production accurately in forms, reports, logs, and batch/equipment records using Good Documentation Practices
- Train and mentor new team members; onboard and author procedures for new equipment
- May collect, record, and analyze data; interpret process bottlenecks and implement process improvements
- Perform characterization assays and transfer developmental improvements to manufacturing via training/technical transfer
Qualifications/Skills:
- High school diploma or GED required; Associate or Bachelor’s degree preferred (Science)
- 5+ years of industry experience
- Hands-on lab experience (e.g., HPLC purification and/or small molecule synthesis, cGMP clean room, oligonucleotide synthesis, mRNA)
- Experience drafting/editing/implementing/executing Standard Operating Procedures
- Strong written and verbal skills; self-motivated with ability to organize/prioritize multiple tasks
- Ability to mentor others on processes
Benefits (explicitly stated): RSU grants/employee stock purchase plans; comprehensive medical plans with HSA/FSA; fertility & family planning assistance; optional benefits/insurance (including pet insurance); retirement contributions; holidays & paid time off.
Application instructions:
- Visit https://www.maravai.com/careers/ for more opportunities.