Senior Process Development & Manufacturing Specialist
About The Position
Maravai LifeSciences is seeking a Senior Process Development & Manufacturing Specialist to join their CDMO team. This role involves leading the transfer, execution, and optimization of processes for GMP-grade oligonucleotide and mRNA production within a CDMO environment. The specialist will combine advanced technical expertise in IVT synthesis, downstream purification, and wet chemistry operations with ownership of process performance, scalability, and manufacturing readiness. As a subject matter expert, this position drives process improvements, supports client programs, and ensures successful technology transfer from development into GMP manufacturing. The role operates with a high degree of autonomy, partnering cross-functionally with Manufacturing, Quality, and Commercial teams to deliver high-quality and scalable solutions for external clients.
Requirements
- Bachelor’s degree in Chemistry, Biochemistry, Molecular Biology, or related scientific discipline with 5–8+ years of relevant experience, or advanced degree with industry experience.
- Strong hands-on experience in GMP manufacturing environments, including oligonucleotide or mRNA production, purification (HPLC), and scale-up.
- Demonstrated expertise in process development, tech transfer, and process optimization within regulated environments (ICH Q7, ISO cleanrooms).
- Proven ability to analyze process data, troubleshoot technical issues, and implement process improvements.
- Experience authoring and reviewing GMP documentation, including SOPs, batch records, and technical reports.
- Strong communication and leadership skills, with experience mentoring staff and supporting cross-functional and client-facing interactions.
Responsibilities
- Lead execution and optimization of manufacturing processes for GMP-grade oligonucleotides and mRNA, ensuring product quality, consistency, and process efficiency.
- Lead tech transfer activities, translating development processes into robust, scalable GMP manufacturing workflows.
- Drive process improvement and scale-up initiatives by analyzing process data, identifying bottlenecks, and implementing sustainable solutions.
- Support equipment performance and process reliability by troubleshooting issues, identifying root causes, and collaborating on corrective and preventive actions.
- Author, review, and implement GMP documentation, including batch records, SOPs, and technical reports in accordance with Good Documentation Practices.
- Serve as a technical subject matter expert, providing guidance, training, and mentorship to manufacturing staff and supporting cross-functional problem-solving.
- Collaborate with internal stakeholders and client-facing teams to support technical discussions, custom process requirements, and successful program execution.
- Conduct characterization and process development studies to support continuous improvement and product scalability.
- Perform other functions and duties as
Benefits
- highly competitive long-term incentives in the form of company equity
- bonus participation
- company sponsored benefits
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Number of Employees
251-500 employees
