Senior GMP 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 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 excited to welcome a new #MiracleMaker to our Operations team as a Senior GMP Process Development Specialist. This is a unique opportunity to play a handson role in developing and optimizing purification methods supporting seamless technology transfer into cGMP manufacturing and driving innovation within our operations. Youll be part of a collaborative and purposedriven team where your work will make a real differencehelping us deliver highquality products on time while pushing the boundaries of scientific discovery in a dynamic regulated environment.

How will you make an impact:

• Develop materials necessary to purify cGMP enzyme batches in ISO class C and class D cleanrooms
• Execute cGMP production in controlled environments ability to gown in 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 including cell rupture lysate clarification filtration/centrifugation column chromatography (GE AKTA systems) and precipitation
• Contribute to development projects including planning strategic direction experimental design data analysis and interpretation
• Perform inprocess product testing including gel electrophoresis and protein determination
• Pack and evaluate chromatography columns for GMP purifications
• Complete batch records according to Quality System requirementsDocument compile 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
• Research new equipment and technologies that contribute to platform improvement
• Identify technical issues troubleshoot and solve problems to achieve clear resolutions
• Provide effective management for planning coordinating and executing tasks and projects in a given time frame
• Perform other functions and duties as required

The skills and experience that you will bring:

• Bachelors degree in Biology Immunology Biochemistry Biotechnology or a related field with 5 years of experience in GMP manufacturing or a Masters degree with 3 years of experience.
• Handson experience with liquid chromatography techniques (affinity IEX HIC SEC) using GE AKTA/Unicorn systems including method development troubleshooting and scaleup.
• Extensive experience in buffer preparation protein analysis and downstream bioprocess development.
• Proven ability to implement purification strategies and transfer processes to largescale GMP production.
• Strong understanding of cGMP ISO 9001 and/or ISO 13485 regulations ISO class C and class D cleanrooms.
• 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 fastpaced regulated environment while ensuring compliance with Quality Assurance standards work instructions and SOPs.

#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.

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