Why this role matters
As a QC Specialist, you will join our Technical Operations team and play a key role in the establishment, development, and management of quality control activities for bacteriophage production. This position is critical to ensure robust, safe, and compliant production of phage batches in a regulated environment.
The role involves setting up an internal QC laboratory, defining analytical strategies, qualifying and transferring methods from R&D to GMP, establishing in-process and release testing, and contributing to CMC documentation and regulatory submissions. This position offers a unique opportunity to shape the QC function in a growing, innovative biotech environment 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.
- Ensure methods 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.
- Maintain comparability and consistency of methods between internal and external sites.
- Manage contracts, scope of work, and technical follow-up with analytical partners.
QC System 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
- Contribute analytical data and documentation for regulatory submissions (IMPD, IND, BLA/MAA).
- Support preparation 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.
- Draft and 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
- Participate to the establishment of release criteria and analytical specifications for bacteriophage batches.
- Participate to the design of in-process control strategies for each production stage.
- Collaborate closely with Process Development and Manufacturing to identify critical points and 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’s or PhD in Microbiology, Virology, Biotechnology, Bioengineering, Molecular Biology, or related field; specialization in bacteriophages, viral products, or advanced therapies is a plus.
- 3–7 years in QC, Analytical Development, or Technical Operations in biotech/pharma.
- Proven expertise 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 outsourced testing.
- Strong organizational, analytical, and problem-solving skills.
- Excellent communication and cross-functional collaboration abilities.
- Ability to work independently in fast-paced, start-up environments with initiative and a proactive, solution-oriented mindset.
What you’ll love about working here
Inspiring Mission
Join a high-potential biotech fighting antimicrobial resistance with cutting-edge science.
Strategic Impact
Lead global efforts to bring next-gen solutions to market and transform the fight against antibiotic resistance.
Growth Opportunities
Develop your skills and grow professionally in a dynamic environment.
Empowered Leadership
Drive change within a passionate team that supports and challenges each other to excel.
Attractive Compensation
Enjoy a competitive package aligned with your role and experience.
Work-Life Flexibility
Benefit from hybrid work and flexible hours tailored to your lifestyle.
Innovation Culture
Be part of a team that values collaboration, creativity, and mission-first thinking.
Fun & Team Spirit
Enjoy team breakfasts, lunches, afterworks, and memorable team-building moments.
Ready to make an impact?
We’d love to hear your story. Apply today!