Senior Process Development & Manufacturing Specialist

Reposted 4 Days Ago
Be an Early Applicant
San Diego, CA, USA
In-Office
90K-100K Annually
Senior level
Biotech
The Role
The Senior Process Development & Manufacturing Specialist leads the optimization and execution of processes for GMP-grade oligonucleotide and mRNA production, ensuring quality and scalability while supporting technology transfer and process improvements.
Summary Generated by Built In

Who we are: 

Maravai LifeSciences translates extraordinary science into everyday miracles, helping biotech, biopharma, and life sciences companies everywhere deliver novel vaccines, therapeutics, and diagnostics. We are global leaders in providing products and services within the fields of nucleic acid production and biologics safety testing to many of the world's leading biopharma, vaccine, diagnostics, and cell and gene therapy companies.  

At Maravai, we believe that diverse perspectives are the foundation of innovation. Through an inclusive and equitableculture where every team member is inspired to bring their best selves to work, we cultivate an environment in which we can lead together, providing differentiated value to our customers, and enabling the miracles of science. For over 35 years, Maravai’s portfolio companies have served as a catalyst for innovative, lifesaving technology for humanity. Pioneering nucleotide research since its inception, we are now leading the way in the rapidly expanding mRNA market. 

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 required 

 The skills and experience that you will bring: 

  • 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.

The anticipated salary range for this position is $90,000 - $100,00.  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 candidate's skills, experience and other qualifications, as well as the location of the role.  

#LI-Onsite

The benefits of being a #MiracleMaker: 

  • You have the potential to change, improve, and save lives around the world. 
  • You have the opportunity to be a part owner in Maravai through RSU grants and optional employee stock purchase plans. 
  • We offer 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. 

Benefits may vary by region and employment type and do not apply to temporary employees or contractors. See a comprehensive list of benefits at our Benefits & growth site at https://www.maravai.com/careers/benefits-and-growth/ 

To view more opportunities to become a #MiracleMaker, visit our career site at  https://www.maravai.com/careers/  

Maravai LifeSciences is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation, and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law. 

Click here to view Maravai LifeSciences Privacy Notice 


HIRING SCAM ALERT 

Recently, individuals impersonating Maravai LifeSciences Human Resources members have offered fraudulent interviews and job offers to unsuspecting candidates. To help protect you from these scam artists, please be aware that: 

  • Maravai LifeSciences will never interview a candidate over RingCentral, similar messaging apps or social media (e.g. Telegram, Google Hangouts, WhatsApp, Facebook Messenger, etc.) 
  • Maravai LifeSciences will never send a company check or ask an applicant to pay a fee or purchase at home work/training materials in connection with an application for employment. 
  • Maravai LifeSciences will never provide excess money to an applicant and ask the applicant to write a check for repayment. 

 If you have any doubt about a job offer or any other communication purporting to come from Maravai LifeSciences, please reach out to us directly at [email protected]. If you believe you have been a victim of fraud, you can report this activity at: www.iC3.gov or www.stopfraud.gov. 

Skills Required

  • Bachelor's degree in Chemistry, Biochemistry, Molecular Biology, or related scientific discipline
  • 5-8+ years of relevant experience, or advanced degree with industry experience
  • Strong hands-on experience in GMP manufacturing environments
  • Demonstrated expertise in process development and tech transfer
  • Experience authoring and reviewing GMP documentation
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The Company
HQ: San Diego, CA
317 Employees
Year Founded: 1996

What We Do

TriLink’s CDMO services offer a range of manufacturing grade products from discovery-grade (RUO) to its customizable intermediate-grade - GMPLink™ to full GMP-grade with scale-up and technology transfer expertise. TriLink operates a quality system in compliance with ICH Q7, Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, Section 19, APIs for Use in Clinical Trials, and ISO 9001:2015 standards. TriLink continues to expand its cGMP and general mRNA, oligonucleotide & plasmid manufacturing capacity at its new global headquarters to support therapeutic, vaccine and diagnostic customers.

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