USP Scientist Process Development & GMP

USP Scientist Process Development & GMP – Exothera

As a USP Scientist in a dynamic CDMO environment, you are responsible for upstream process development and hands‑on scientific support during GMP manufacturing activities
. You will design and execute experiments to develop robust, scalable upstream processes and ensure their successful implementation during engineering runs, GMP campaigns, and tech transfers
.

You act as a key scientific interface between development and manufacturing
, ensuring continuity, compliance, and operational excellence across both phases of the product lifecycle.

• Design and perform upstream experiments (e.g., cell culture, viral vector production, bioreactor ops – adherent and suspension).
• Identify and assess critical process parameters (CPPs) and develop process robustness and scalability strategies.
• Prepare and execute DoE‑based studies
  , analyze data, and summarize results in technical reports.
• Collaborate with other scientists and technicians to implement best practices in development lab operations
  .
• Evaluate single‑use assemblies, raw materials, and suppliers from a technical and quality perspective.
• Write development protocols, study plans, and process characterization documentation.

• Serve as the scientific owner of the USP process during GMP engineering and production batches.
• Provide on‑the‑floor support during GMP operations
  , working closely with manufacturing technicians and QA to ensure compliant execution.
• Author and/or review GMP documentation, including batch records, process descriptions, and BOMs
  .
• Support investigations, change controls, and deviations as the USP subject matter expert (SME).Contribute to the continuous improvement of manufacturing operations by analyzing process data and trends.

• Act as technical liaison between USP development and other operational departments as QA/QC, analytics…
• Participate in project meetings, sharing scientific insights and aligning development outputs with GMP needs.
• Assist in the training and technical mentoring of USP technicians and junior staff.
• Represent the USP function during client audits or technical meetings, presenting data and justifying decisions.

• Master’s degree or PhD in Biotechnology, Bioprocess Engineering, or related Life Sciences field.

• Strong knowledge of upstream processes: cell culture, viral vector or vaccine production, bioreactors.
• Good understanding of GMP principles
  , batch execution, and manufacturing documentation.
• Proficiency in experimental design, data analysis, and process optimization.
• Excellent communication and documentation skills; able to interact with clients and internal stakeholders.
• Hands‑on, proactive, and detail‑oriented mindset.
• Fluent in English (French is an asset).

• 2–5+ years in biotech or biopharma
  , ideally in a CDMO or GMP development/manufacturing setting
  .
• Proven experience in USP process development and Good understanding of GMP practices.
• Familiarity with tech transfer
  , engineering runs, and troubleshooting in regulated environments.

We provide an attractive compensation package
, tailored to your experience and expertise, including:

A permanent employee contract (CDI)

A company car with a fuel card

A comprehensive group insurance plan (hospitalization, outpatient care, etc.)

An annual performance bonus

Beyond these benefits, you’ll have access to continuous training
, personalized development support
, and genuine career growth opportunities
.

You’ll thrive in a stimulating work environment within an innovative biotech company
, where every day brings new challenges and meaningful impact
.

Ready to make a difference?
If this sounds like you and you’re looking for a dynamic and demanding role
, we’d love to hear from you —
apply today!