Remote MSAT Scientist: Biologics Process Transfer

Amaris Consulting

Geel

Sur place

EUR 70 000 - 110 000

Plein temps

Il y a 4 jours

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Avantages offerts par ce poste

Health insurance

Remote work

Meal vouchers

Time savings account

Referral bonus

Résumé du poste

Amaris Consulting is seeking a Scientist in MSAT to support introduction, optimization and lifecycle management of biologics manufacturing processes at clinical and commercial scale. The role bridges development labs and GMP manufacturing to drive technology transfer and process improvement.

You will collaborate with multidisciplinary teams, apply statistical data analysis, and ensure compliance with GMP and regulatory standards while contributing to robust manufacturing strategies and product

Qualifications

PhD in Life Sciences with ≥3 years experience in process development or MSAT-like roles, or Master’s in Life Sciences with ≥5 years relevant experience.
Hands-on experience with mammalian cell culture and/or downstream purification at lab and/or manufacturing scale.
Familiarity with statistical and data trending techniques; experience with JMP, Statistica, Matlab or Simca is a plus.
Good understanding of GMP; prior GMP or MSAT experience is an asset.
Fluent in English, able to communicate clearly with multidisciplinary and international teams.
Flexible, willing to support occasional evening/weekend manufacturing activities and switch between lab- and plant-based work.
Strong team player with good interpersonal skills, able to build relationships and align stakeholders.
Detail-oriented, analytical, structured in documentation and data handling, with a proactive problem-solving attitude.

Responsabilités

Support technology transfer of new drug substance processes from development to large-scale GMP manufacturing, ensuring documentation readiness (fit-gap, control strategy, batch sheets, sampling plans).
Provide scientific and on-floor support during process performance qualification (PPQ) and initial manufacturing campaigns.
Identify and lead process improvement initiatives to increase yield, robustness and cost‑effectiveness, and build data packages to enable GMP implementation.
Perform data trending and monitoring of key process parameters and quality attributes for commercial processes, and propose data‑driven actions.
Design and document technical studies (protocols and reports) to support significant process changes and lifecycle activities.
Contribute to investigations and process/product impact assessments in case of manufacturing deviations.
Collaborate with lab teams on small‑scale studies and translate lab findings into robust manufacturing‑scale strategies.
Use statistical and data trending tools (e.g. JMP, Statistica, Matlab, Simca or equivalent) to strengthen process understanding and decision‑making.
Ensure all activities comply with GMP, internal quality standards, safety policies and regulatory expectations.