Senior GMP Process Operator, Downstream

Maravai LifeSciences
paid time off
United States, Florida, Jupiter
Feb 20, 2025
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 Operations team as a Senior GMP Process Operator, Downstream. As a Senior GMP Process Operator, Downstream, you will lead the execution of enzyme purification projects, develop and optimize purification methods, and ensure technology transfer to cGMP manufacturing in alignment with customer timelines and internal priorities. This role involves designing scalable purification processes, producing enzyme batches, conducting equipment validation, and maintaining compliance with FDA's 21 CFR 211/820 design control requirements while working in both laboratory and cleanroom environments. If this sounds like you, we want to hear from you! How you will make an impact: Prepare all materials necessary to purify GMP enzyme batches in ISO Class C and Class D cleanrooms. Execute cGMP production in controlled environments, including gowning in appropriate cleanroom attire. Participate in tech transfer and implementation of purification strategies to meet product design specifications. Purify GMP enzymes from bacterial and eukaryotic cell cultures using various purification techniques (cell rupture, lysate clarification, filtration/centrifugation, column chromatography (GE AKTA systems), and precipitations). Perform in-process product testing, including gel electrophoresis and protein determination. Pack and evaluate chromatography columns for GMP purifications. Complete batch records according to Quality System requirements and analyze GMP production data. Communicate results at team meetings and contribute to project planning. Develop and maintain protocols, operational processes, and safety best practices. Collaborate cross-functionally with internal teams, external partners, and customers. Contribute to development projects, including planning, experimental design, data analysis, and platform improvements. Research new equipment and technologies for process optimization. Identify, troubleshoot, and resolve technical issues to maintain efficient production. The skills and experience that you will bring: Bachelor's degree in Biology, Immunology, Biochemistry, Biotechnology, or a related field with 5 years of experience, or a Master's degree with 3 years of experience. Hands-on experience with liquid chromatography techniques (affinity, IEX, HIC, SEC) using GE AKTA/Unicorn systems, including method development, troubleshooting, and scale-up. Extensive experience in buffer preparation, protein analysis, and downstream bioprocess development. Proven ability to implement purification strategies and transfer processes to large-scale GMP production. Strong understanding of cGMP, ISO 9001, and/or ISO 13485 regulations. Proficiency in MS Word, Excel, PowerPoint, and data analysis tools. Excellent analytical, organizational, and communication skills, with a proactive approach to troubleshooting and process optimization. Ability to manage multiple tasks in a fast-paced, regulated environment while ensuring compliance with Quality Assurance standards, work instructions, and SOPs. #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 ourBenefits & 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 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.