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Msat process engineer [f/m/x]

Geel
Amaris Consulting
Publiée le 8 juin
Description de l'offre

Job description

Role Overview

As an MSAT Upstream Scientist, you will leverage your strong scientific and technical expertise in mammalian cell culture to:

* Drive technology transfer activities for new products and processes to the manufacturing site

* Support and optimize existing commercial manufacturing processes

* Contribute to continuous improvement initiatives across the site and the wider nerwork

The role is primarily focused on manufacturing‑scale activities, with close collaboration with laboratory teams for small‑scale studies and troubleshooting.

Key Responsibilities

* Technology Transfer & New Product Introduction

o Facilitate the transfer of new drug substance manufacturing processes from development laboratories to large‑scale GMP facilities.

o Ensure documentation readiness for clinical and commercial production (e.g. process fit–gap analyses, process control strategies, media batch sheets, sampling plans).

o Support process performance qualification (PPQ) to ensure successful implementation at manufacturing scale.

* Process Optimization & Continuous Improvement

o Identify, lead, and execute process improvement initiatives to increase yield, robustness, and efficiency of upstream processes.

o Design and interpret studies to generate data packages enabling implementation of improvements at manufacturing scale.

* Commercial Manufacturing Support

o Perform data trending and monitoring of existing commercial processes to ensure process control and product quality.

o Develop scientific and technical study protocols and reports to support significant process changes.

o Contribute to investigations and process/product impact assessments in case of significant manufacturing deviations.

* Cross‑Functional Collaboration

o Work closely with manufacturing, quality, development, and other MSAT teams.

o Act as a scientific partner for stakeholders, facilitating discussions and aligning on technical solutions.

Candidate Profile

Education & Experience

* PhD in Life Sciences (Biotechnology, Biochemistry, Bioengineering, or related field) with ≥ 3 years relevant experience in process development or MSAT‑like roles

or

* Master’s degree in Life Sciences with ≥ 5 years relevant experience in process development or MSAT‑like roles

* Overall level of experience: 4–6 years (Middle level)

Technical Skills

* Proven hands‑on experience with mammalian cell culture processes at laboratory and/or manufacturing scale

* Understanding of upstream bioprocess unit operations (e.g. seed train, bioreactor operations, feeding strategies, process control)

* Familiarity with downstream purification processes is a strong plus

* Good knowledge of current Good Manufacturing Practices (GMP); prior GMP manufacturing or MSAT experience is an asset

* Experience with statistical and data trending tools (e.g. JMP, Statistica, Matlab, Simca) is a plus

Soft Skills & Ways of Working

* Fluent in written and spoken English; comfortable working in an international, cross‑site environment

* Strong analytical and problem‑solving skills with a precise, detail‑oriented mindset

* Effective team player, able to work across multidisciplinary teams and build productive relationships

* Strong interpersonal and communication skills; able to facilitate discussions and negotiate compromises with other departments or sites

* High degree of flexibility and resilience:

o Willingness to adapt to changing priorities in a fast‑paced environment

o Availability for occasional evening or weekend support when required

o Comfortable supporting both small‑scale lab studies and large‑scale manufacturing operations

Why joining us?

Rapid growth: Amaris has doubled its workforce in Belgium in two years, providing numerous growth opportunities for employees.

Prestigious projects: Candidates will work with renowned clients in the pharmaceutical, biotechnology, and European institutions sectors on impactful missions.

International environment: An agile and dynamic structure promotes intrapreneurship and meritocracy, with international exposure at the heart of Europe.

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