QC Specialist

Location: Town of Belgium

As a QC Specialist
, you will join our Technical Operations teamand play a key role in the establishment, development, and management ofquality control activities for bacteriophage production. This position is critical to ensure robust, safe, and compliant production of phage batches in aregulated environment.

The role involves setting up an internal QC laboratory, defininganalytical strategies, qualifying and transferring methods from R&D to GMP,establishing in-process and release testing, and contributing to CMCdocumentation and regulatory submissions. This position offers a unique opportunity to shape the QC function in a growing, innovative biotechenvironment with potential evolution toward QC Manager

What your days could look like Analytical Method Development, Qualification & Transfer

• Develop, optimize, and validate analytical methods for bacteriophages (titer, purity, identity, endotoxins, sterility, HCP, genomic characterization).
• Coordinate or perform method transfers from R&D to QC laboratories or CMOs.
• Support analytical method qualification/validation according to ICH Q2, Ph. Eur., EMA/FDA guidelines.
• Ensuremethods are robust, industrializable, and suitable for preclinical, clinical,and commercial batches.

Management of QC Testing (Internal & External)

• Define strategy for internal vs. outsourced QC testing and manage external analytical laboratories.
• Monitor technical, quality, and regulatory compliance of external laboratories.
• Maintaincomparability and consistency of methods between internal and external sites.
• Managecontracts, scope of work, and technical follow-up with analytical partners.

QCSystem Setup and Management

• Develop, structure, and implement a comprehensive QC system for bacteriophage production.
• Define and supervise QC processes, including in-process controls, release testing, and environmental monitoring.
• Support the establishment of an internal QC laboratory: equipment acquisition,installation, and qualification.
• Ensure
  
  QC activities comply with GMP-like standards and regulatory guidelines.

Support for CMC & Regulatory Activities

• Contributeanalytical data and documentation for regulatory submissions (IMPD, IND,BLA/MAA).
• Supportpreparation for audits and inspections.
• Provide technical expertise during multidisciplinary reviews (process changes,equipment upgrades, scale-up).

Documentation& Quality Compliance

• Ensure data integrity (ALCOA+), traceability, and adherence to GMP standards .
• Draftand review protocols, SOPs, reports, and specifications files.
• Support
  
  QA during audits and inspections regarding analytical methods, transfers, and validation activities.

Release Specifications & In-Process Testing

• Participateto the establishment of release criteria and analytical specifications forbacteriophage batches.
• Participateto the design of in-process control strategies for each production stage.
• Collaborate closely with Process Development and Manufacturing to identify critical pointsand implement appropriate testing.

Team Development & Cross-Functional Collaboration

• Participate in training and coaching of QC analysts.
• Collaborate closely with R&D, Manufacturing, QA, and Technical Operations to ensure quality and analytical alignment.

What you bring to the table

• Master’sor PhD in Microbiology, Virology, Biotechnology, Bioengineering, Molecular Biology, or related field; specialization in bacteriophages, viral products, or advanced therapies is a plus.
• 3–7years in QC, Analytical Development, or Technical Operations in biotech/pharma.
• Provenexpertise in analytical method development, validation, and GMP-compliant QC.
• Experience with bacteriophages, viruses, biologics, vaccines, or ATMPs highly valued.
• Knowledge of microbiological, virological, and analytical QC methods (plaque assays,qPCR, sterility, endotoxins, purity, identity, genomic analyses).
• Familiarity with ICH Q2, GMP, Ph. Eur., EMA/FDA guidelines, and CMC principles.
• Experience in equipment and method qualification/validation and management of outsourcedtesting.
• Strong organizational, analytical, and problem-solving skills.
• Excellent communication and cross-functional collaboration abilities.
• Abilityto work independently in fast-paced, start-up environments…