Staff Process Development Specialist
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
Maravai LifeSciences is seeking a #MiracleMaker to join our Process Development team as a Staff Process Development Engineer. As a Staff Process Development Engineer you will be responsible for complex and strategic tasks, including overseeing multiple projects, developing long-term process improvement strategies, and ensuring alignment with organizational goals. All processes must be robust, efficient, and compliant with phase appropriate regulatory standards, with a particular focus on mRNA. Additionally, this role supports interdepartmental biomolecule R&D and CDMO projects, ensuring alignment with Good Manufacturing Practices (GMP) across all process development activities.
How you will make an impact:
- Lead and manage process development projects from concept through commercialization, adhering to timelines and regulatory constraints.
- Specification and requirement setting for raw materials, supplies, and equipment for mRNA processing.
- Develop and analyze product life cycle with emphasis on risk assessment for materials and process.
- Conduct hands-on experiments to identify inefficiencies and optimize processes. Manage lab-based process development projects, ensuring timely completion and accurate results.
- Propose innovative ideas and foster meaningful scientific discussions.
- Identify and optimize processes tailored to the unique characteristics of a variety of mRNA drug substances.
- Lead and manage complex drug development projects, ensuring alignment with client objectives and regulatory requirements e.g. lead FMEA, Gap assessment, DOEs, etc.
- 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.
- 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, Batch Records, Protocols, and Reports and train staff on new processes. Maintain detailed lab notebooks and prepare reports on experimental findings.
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 developing and resolving e complex models and procedures, aligning them with company objectives. Offers creative solutions, understands interdisciplinary interactions, and drives policy development
- Proficient with large scale purification skids and have a strong understanding of UFDF
- Experience with statistical analysis software (e.g., JMP, Minitab) is highly desirable.
- Experience in nucleic acid wet lab techniques including but not limited to the following;
- In vitro enzymatic reactions (e.g. restriction digest, PCR, transcription)
- Column purification
- TFF/UFDF
- Filtration
- Analytical Methods (HPLC, Mass Spec, gel/capillary electrophoresis, qPCR, ELISA, etc.)
- 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
- Ability to independently identify problems and offer effective solutions
- Willingness and ability to lead projects independently
The anticipated salary range for this position is $107,997 - $120,000. 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.
#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.
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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.
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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.
