Scientist, Process Development, Tech Ops

The Scientist, Process Development supports the execution of process development activities within Horizon 2 programs, contributing to the development and improvement of manufacturing processes for innovative therapies. The role performs laboratory‑based experimental work under the guidance of senior scientists, generating high‑quality data that supports process understanding, development decisions, and regulatory readiness. The Scientist applies established scientific principles, experimental techniques, and standard laboratory methods to execute defined studies, analyze results, and document outcomes in accordance with internal quality standards and regulatory expectations. The role contributes to Life‑Cycle Management (LCM) and Sustain & Improve activities through assigned tasks and supports the application of Quality by Design (QbD) principles by generating reliable data that informs process characterization and control strategies. Operating within a matrix project environment, the Scientist collaborates closely with colleagues across Process Development, Analytical, and other partner functions, while continuing to build technical expertise, scientific judgment, and independence in experimental execution.

Main Responsibilities & Accountabilities

• Execute laboratory and process development experiments according to defined protocols, study plans, and timelines, under the guidance of senior scientists or technical leads.
• Apply established scientific methods and standard analytical and process‑development techniques to generate accurate, reliable, and reproducible data.
• Support Quality by Design (QbD) activities by contributing experimental data that informs understanding of process parameters, variability, and critical quality attributes (CQAs).
• Analyze experimental results, document observations, and contribute to the interpretation of data and preparation of technical summaries and development reports.
• Prepare and maintain high‑quality laboratory documentation (e.g., lab notebooks, protocols, reports) in compliance with internal quality systems, data integrity requirements, and regulatory expectations.
• Contribute to assigned Life‑Cycle Management (LCM) and Sustain & Improve activities through execution of defined experimental tasks.
• Collaborate effectively within project teams and laboratory groups, communicating results, issues, and learnings in a clear and timely manner.
• Adhere to all applicable safety, quality, compliance, and regulatory requirements while performing laboratory and development activities.

Qualifications & Experience Requirements

• BS or MS in Biochemistry, Life Sciences, or a closely related discipline is required; PhD or equivalent experience preferred.
• 2+ years of industry and managerial experience in pharmaceutical or biological operations, including protein/biological process development.
• Ability to work cross‑functionally.

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