Staff Process Development Specialist
Staff Process Development Specialist
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Job Description
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 worlds 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 Maravais 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 longterm 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 handson experiments to identify inefficiencies and optimize processes. Manage labbased 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 scaleup.
- Gather and analyze data using statistics measurement systems analysis and design of experiments efforts and their associated analysis tools.
- Collaborate crossfunctionally 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 andtrain 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 Masters 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
- Selfmotivated with ability to multitask meet project deadlines and work in fastpaced 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 $107997 $120000.In addition highly competitive longterm 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.
#LIOnsite
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 ourBenefits & growth site at view more opportunities to become a #MiracleMaker visit our career site at 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 . If you believe you have been a victim of fraud you can report this activity at: or .
Required Experience:
Staff IC
Employment Type
Full-Time
