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Senior Reagent Manufacturing Associate

Nautilus Biotechnology

Nautilus Biotechnology

San Carlos, CA, USA
Posted on Saturday, July 29, 2023
At Nautilus, we have a big and important mission: improve the health of millions by unleashing the potential of the proteome to accelerate drug development and enable a new world of precision and personalized medicine. We are developing a single-molecule protein analysis platform of unprecedented sensitivity, scale, and ease of use that we believe will democratize access to the proteome – one of the most dynamic and valuable sources of biological insight. To accomplish this, we are pursuing deep, hard science with an entrepreneurial mindset and creating a world-class team of builders, innovators, and dreamers across a wide range of disciplines.
We are hiring for a Senior Reagent Manufacturing Associate to join our growing team. We are continuing to expand our internal reagent production team to focus on reagent production using several bioconjugation protocols developed at Nautilus. This role will be manufacturing test reagents for our next generation proteomics platform. You will be working cross-functionally with R&D scientists to learn reagent production processes, collaborate to adapt the processes for production scale and work on qualifying reagents produced to ensure that specifications and functionality are met. The ability to work collaboratively to accomplish tasks is highly valued. Ideal candidates must be self-starters, with strong attention to detail, highly experienced on bench and production environments, and have a deep understanding of good manufacturing practices, continuous process improvement, quality-first mindset and strong understanding of molecular and cell biology.
This position will report to the Senior Manager of Reagent Manufacturing. The position is located in San Carlos, CA and requires full-time onsite presence.

Responsibilities

  • Execute reagent manufacturing activities/tasks
  • Culture and transfect mammalian cells for use in protein production
  • Process production orders in a timely manner
  • Collaborate cross-functionally to ensure on-time completion of production builds
  • Assist in the development and technology transfer of reagent manufacturing processes and documentation, maintaining the accuracy and validity of testing results
  • Perform verification assessments, build pilot lots, and scale-up to support new reagents/products to full production-scale manufacturing
  • Serve as a resource to other departments to create, facilitate, monitor, and communicate project schedules so that they are driven to completion and their status are known by all team members as well as management
  • Maintain records and clean room environment in compliance with good manufacturing practices and standard operating procedures
  • Learn new reagent formulations and processes, create required documentation – batch records, work instructions and SOPs and provide training/guidance for junior manufacturing team members
  • Assist in inventory management and ordering materials
  • Perform review of new departmental procedures
  • Maintain, troubleshoot, qualify, and validate equipment as appropriate
  • Perform troubleshooting of issues which arise during routine formulations
  • Assist in the development of physical quality specifications and tests
  • Contribute to the transfer of new products/assays and technologies to production
  • Lead scale-up activities
  • Set up and carry out bioconjugation reactions on various protein samples
  • Collaborate with upstream research teams to troubleshoot failed reactions
  • Collaborate with multiple teams performing affinity reagent discovery and characterization
  • Routinely present results/findings/data to various teams within the company
  • Contribute to authoring Standard Operating Procedures, Standard Test Procedures, Master Batch Records, and other documents

Requirements

  • BS/MS in Biochemistry/Molecular Biology, Chemistry, or related degree
  • Sr. RMA I requires 6+ years related hands-on experience in reagent production
  • Strong technical skills, including a working understanding of molecular biology, biochemistry, and/or chemistry
  • Experience with scaling up a process or optimization of an existing process
  • Experience in new product introduction, pilot builds and transfer into manufacturing
  • Experience in formulation and filtration techniques, such as TFF
  • Experience with data analysis tools (JMP, R) for statistical process control (plus)
  • Experience with protein purification and protein characterization through a number of assays, including PAGE and ELISA
  • Ability to perform unit conversion calculations
  • Proficiency with Excel
  • Possess attention to detail, strong organizational skills, and effective interpersonal and communication skills
  • Capable of multi-tasking and changing priorities caused by time, markets, customers, budget, or other constraints
  • Demonstrated analytical, troubleshooting, and problem-solving skills
  • Work collaboratively with multidisciplinary functions to achieve maximum efficiency

  • Preferred Qualifications
  • Experience with HPLC or equivalent
  • Experience operating liquid handlers and other automated equipment
  • Understanding of ISO/GMP standards a plus
  • Experience with ERP, PLM and LIMS systems
  • Experience in root cause analysis, quality investigations and CAPA
  • Strong understanding of lean and 5S principles

Nautilus Team Culture

  • We are curious go-getters: this is a team of life-long learners who aren’t afraid to tackle the big challenges and we embrace the journey
  • We are detail oriented: we do great science by working smart & with diligence where we learn from our trials and mistakes
  • We are easy to work with: we want our workplace to be one where everyone can share their perspective and be treated with respect and kindness
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