Downstream Process Scientist

Vantive; Castlebar; On-site; EUR 60,000 - 90,000; Full time

Benefits offered by this job

Private medical insurance

Company pension scheme

Annual bonus scheme

Access to state‑of‑the‑art equipment

Job summary

Vantive in Ireland seeks a Downstream Process Scientist to lead pilot-scale purification studies for API programs. You will collaborate with engineering and manufacturing to develop scalable processes and support tech transfer.

You will execute UF/DF and filtration, perform process analytics, design experiments, and contribute to cGMP compliance and regulatory expectations.

Qualifications

• Must have 2+ years (MS/MA) or 5+ years (BS/BA) in basic science with API manufacturing support experience.
• Experience with cGMP compliance and US/EU regulations.
• Experience with downstream/analytical processes at small-to-intermediate scale (UF/DF, filtration).
• Experience with process scaling and/or technology transfer.
• Strong organizational skills and ability to communicate data clearly.

Responsibilities

• Support commissioning and start-up of pilot scale lab.
• Execute downstream process steps at pilot scale (UF/DF and filtration).
• Perform process analytics (pH, SEC, OR).
• Design experimental approaches to address manufacturing challenges.
• Work on development pilot-scale projects with team meetings, data management, investigations, and reports.
• Author/protocols, data interpretation, and report generation.
• Support DOE studies to establish PAR for process characterization.
• Perform process monitoring; ensure compliance with site safety and training.
• Assist with troubleshooting of manufacturing events and evaluate new technologies.
• Maintain knowledge of cGMP and regulatory expectations.

Skills

Process analytics

Data interpretation

Problem-solving

Statistical data analysis

Teamwork

Education

M.S./M.A. in a basic science field (2+ years)

B.S./B.A. in a basic science field (5+ years)

Job description

Downstream Process Scientist

The Downstream Process Scientist is responsible for being the primary technical support for API small scale processing, working within a team with engineering and manufacturing colleagues to achieve robust and scalable purification processes to support 2nd generation processes and life‑cycle management. The role requires 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
• Perform 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
• Engage 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 a basic science field with a minimum of 2+ years of relevant experience, or B.S./B.A. in a basic science field with a minimum of 5+ years of relevant experience
• Experience with API manufacturing support
• Knowledge of current Good Manufacturing Practices and 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 effective in a team environment
• Experience using a 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 contact us with the nature of your request and your contact information.