Staff Process Development Engineer

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 equitable culture 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 

TriLink is seeking a talented professional to join our Process Development team as a Staff Process Development Engineer. In this role, you will oversee and manage process development initiatives, leveraging your expertise in single-use components, equipment, test design, statistical analysis, and overall process development.

You will be responsible for designing and testing innovative concepts, optimizing existing processes, and ensuring their successful transition into manufacturing—from Discovery to the commercial phase. This includes developing robust and efficient processes that adhere to phase-appropriate regulatory standards, with a specific focus on nucleic acids. Additionally, you will support interdepartmental biomolecule R&D and CDMO projects, ensuring compliance with Good Manufacturing Practices (GMP) throughout all process development activities.

How you will make an impact:

• Oversee process development projects from concept to commercialization, ensuring alignment with timelines and regulatory requirements.
• Develop PPQ protocol and support execution of PPQ including testing, verification, and documentation activities.
• Specification and requirement setting for raw materials, supplies, and equipment.
• Develop and analyze product life cycle with emphasis on risk assessment for materials and process.
• Assist in the launching of new NPIs through development and scale-up.
• Gather and analyze data using statistics, measurement systems analysis, and design of experiments efforts and their associated analysis tools.
• Collaborate cross-functionally with R&D, Quality Assurance, Regulatory Affairs, and Manufacturing teams to ensure seamless roll out of processes into production.
• Optimize and develop equipment and processes through DOEs, CPPs, and CQAs.
• Mentor and guide junior specialists, fostering a culture of continuous learning and development within the team.
• Follow design, quality, and safety guidelines based on GMP, regulatory, and ISO guidelines and related Quality and Safety Standards and Practices.
• Create detailed process documentation including SOPs and Batch Records, and train staff on new processes.
• Handles complex issues and conducts thorough evaluations to devise methods and procedures for new assignments. Exercises judgment in selecting and adapting techniques, ensuring work aligns with departmental goals.
• Perform other functions and duties as required.

 The skills and experience that you will bring: 

• A Bachelor of Science in scientific field; preferably Molecular Biology, Biochemistry, Chemical Engineering or equivalent with minimum of 8 years of related experience; or 6 years and a Master’s degree; or a PhD with 3 years of experience.
• Extensive experience to develop and resolve complex models and procedures, aligning them with company goals. Offers creative solutions, understands interdisciplinary interactions, and drives policy development.
• Proficient with large scale purification skids and have a strong understanding of UFDF
• Strong understanding of regulatory requirements (FDA, EMA, ISO, etc.) and experience in developing processes compliant with these standards.
• Experience statistical analysis software (e.g., JMP, Minitab) is highly desirable.
• Experience in nucleic acid wet lab techniques including but not limited to the following;
  • Precipitation
  • Column purification
  • Gel/capillary electrophoresis
  • In vitro enzymatic reactions (e.g. restriction digest, PCR, transcription)
• Extra consideration for experience in the following techniques;
  • Cell culture
  • Immunohistochemistry/ELISA
  • Gene editing
  • Bioinformatics
  • Diafiltration
• Self-motivated with ability to multitask, meet project deadlines, and work in fast-paced dynamic environment
• Ability to communicate clearly and precisely, both orally and in writing
• Ability to identify problems and offer effective solutions
• Willingness and ability to manage projects through completion

The anticipated salary range for this position is $132,300 - $147,000. 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.  

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. 

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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 taops@maravai.com. If you believe you have been a victim of fraud, you can report this activity at: www.iC3.gov or www.stopfraud.gov.