
USP Scientist Process Development & GMP - Exothera
Company: Exothera
Location: Jumet Nova (UEXO)
Mission:
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.
Key Responsibilities
1. Process Development
- 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.
2. GMP Manufacturing Support
- 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.
3. Cross-functional Collaboration
- 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.
- Contract Labs / Tech Providers
Profile
Qualifications:
- Master’s degree or PhD in Biotechnology, Bioprocess Engineering, or related Life Sciences field.
Skills:
- 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).
Experience:
- 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.
What We Offer
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
Meal vouchers
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!