Senior Process Development & Manufacturing Specialist
San Diego, CA - USA
Job Summary
Your next role as a Miracle Maker
Maravai LifeSciences is seeking a #MiracleMaker to join our CDMO team as a Senior Process Development & Manufacturing Specialist. The Senior Process Development & Manufacturing Specialist is responsible for leading the transfer execution and optimization of processes supporting GMP-grade oligonucleotide and mRNA production within a CDMO environment. This role combines advanced technical expertise in IVT synthesis downstream purification and wet chemistry operations with ownership of process performance scalability and manufacturing readiness. The position is a subject matter expert driving process improvements supporting client programs and ensuring successful technology transfer from development into GMP manufacturing. With a high degree of autonomy this role partners cross-functionally with Manufacturing Quality and Commercial teams to deliver high-quality and scalable solutions for external clients.
How you will make an impact:
- 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
The skills and experience that you will bring:
- Bachelors degree in Chemistry Biochemistry Molecular Biology or related scientific discipline with 58 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.
The anticipated salary range for this position is $90000 - $10000. In addition highly competitive long-term incentives in the form of company equity bonus participation and company sponsored benefits are provided as part of the total compensation package. The salary offer will depend on multiple factors which may include the successful candidates skills experience and other qualifications as well as the location of the role.
#LI-Onsite
Required Experience:
Senior IC
About Company
Maravai’s brands are the proven catalysts for helping biotech, biopharma, and life science companies across the globe to realize the next generation of novel vaccines, therapeutics, and diagnostics.