Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

The Downstream Process Scientist is responsible for being the primary technical support for API small scale processing. They will work as part of a team with engineering and manufacturing colleagues to achieve robust and scalable purification processes to support 2nd generation processes and life-cycle management. This person has in-depth experience with supporting manufacturing processes and/or technical transfer and is expected to support the development of purification processes for our API portfolio.

Responsibilities:

• Support commissioning and start-up of pilot scale lab
• Execution of all downstream process steps at pilot scale, including UF/DF and filtration
• Execution of process analytics including pH, SEC and OR
• Design of experimental approaches to address manufacturing challenges
• Work on development pilot-scale projects, including regular team meetings and updates, data management, investigations, and technical report writing
• Authoring and executing protocols, interpretation of data, and report generation
• Performs all functions associated with process support, e.g. develop process understanding, perform gap analysis/FMEA, generate process models, author/review Process Descriptions and Batch Records, author/review change controls
• Support DOE studies to establish proven and acceptable ranges (PAR) for process characterization
• Perform process monitoring
• Engagement with site safety and training programs to ensure compliance with metrics
• Support troubleshooting of manufacturing process-related events and evaluate new process technologies using scale‑down models
• Maintain knowledge of cGMP compliance, site requirements and regulatory expectations

Education and experience:

M.S./M.A. in basic science field, with a minimum of 2+ years of relevant experience; or B.S./B.A. in basic science field, with a minimum of 5+ years of relevant experience

• Experience with API manufacturing support
• Knowledge of current Good Manufacturing Practices, US / EU regulations.
• Experience with downstream and/or analytical processes at small to intermediate scale - TFF including, UF/DF and filtration
• Experience with process scaling and/or technology transfer.
• Strong organisational skills, attention to detail, and ability to interpret and communicate data.
• Ability to identify scientific/operational gaps and propose solutions.
• Self motivated, able to work independently, and be effective in a team environment.
• Experience using variety of problem solving tools e.g. Fishbone.
• Knowledge of statistical data analysis

What Vantive can offer to you:

• A comprehensive benefits package, including private medical insurance, company pension scheme, and annual bonus scheme
• A collaborative and dynamic work environment
• Access to state-of-the-art equipment and technology
• Recognition and reward for outstanding performance

Reasonable Accommodation

Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link

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