Phage
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 iscritical 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 uniqueopportunity 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.
Managementof 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.
Supportthe establishment of an internal QC laboratory: equipment acquisition,installation, and qualification.
EnsureQC activities comply with GMP-like standards and regulatory guidelines.
Supportfor CMC & Regulatory Activities
Contributeanalytical data and documentation for regulatory submissions (IMPD, IND,BLA/MAA).
Supportpreparation for audits and inspections.
Providetechnical expertise during multidisciplinary reviews (process changes,equipment upgrades, scale-up).
Documentation& Quality Compliance
Ensuredata integrity (ALCOA+), traceability, and adherence to GMP standards .
Draftand review protocols, SOPs, reports, and specifications files.
SupportQA during audits and inspections regarding analytical methods, transfers, andvalidation activities.
ReleaseSpecifications & 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.
Collaborateclosely with Process Development and Manufacturing to identify critical pointsand implement appropriate testing.
TeamDevelopment & Cross-Functional Collaboration
Participatein training and coaching of QC analysts.
Collaborateclosely with R&D, Manufacturing, QA, and Technical Operations to ensurequality and analytical alignment.
What you bring to the table
Master’sor PhD in Microbiology, Virology, Biotechnology, Bioengineering, MolecularBiology, or related field; specialization in bacteriophages, viral products, oradvanced 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.
Experiencewith bacteriophages, viruses, biologics, vaccines, or ATMPs highly valued.
Knowledgeof microbiological, virological, and analytical QC methods (plaque assays,qPCR, sterility, endotoxins, purity, identity, genomic analyses).
Familiaritywith ICH Q2, GMP, Ph. Eur., EMA/FDA guidelines, and CMC principles.
Experiencein equipment and method qualification/validation and management of outsourcedtesting.
Strongorganizational, analytical, and problem-solving skills.
Excellentcommunication and cross-functional collaboration abilities.
Abilityto work independently in fast-paced, start-up environments withinitiative 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.
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.
Be part of a team that values collaboration, creativity, and mission-first thinking.
Enjoy team breakfasts, lunches, afterworks, and memorable team-building moments.
Ready to make an impact? We’d love to hear your story. Apply today!
#J-18808-Ljbffr
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 iscritical 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 uniqueopportunity 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.
Managementof 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.
Supportthe establishment of an internal QC laboratory: equipment acquisition,installation, and qualification.
EnsureQC activities comply with GMP-like standards and regulatory guidelines.
Supportfor CMC & Regulatory Activities
Contributeanalytical data and documentation for regulatory submissions (IMPD, IND,BLA/MAA).
Supportpreparation for audits and inspections.
Providetechnical expertise during multidisciplinary reviews (process changes,equipment upgrades, scale-up).
Documentation& Quality Compliance
Ensuredata integrity (ALCOA+), traceability, and adherence to GMP standards .
Draftand review protocols, SOPs, reports, and specifications files.
SupportQA during audits and inspections regarding analytical methods, transfers, andvalidation activities.
ReleaseSpecifications & 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.
Collaborateclosely with Process Development and Manufacturing to identify critical pointsand implement appropriate testing.
TeamDevelopment & Cross-Functional Collaboration
Participatein training and coaching of QC analysts.
Collaborateclosely with R&D, Manufacturing, QA, and Technical Operations to ensurequality and analytical alignment.
What you bring to the table
Master’sor PhD in Microbiology, Virology, Biotechnology, Bioengineering, MolecularBiology, or related field; specialization in bacteriophages, viral products, oradvanced 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.
Experiencewith bacteriophages, viruses, biologics, vaccines, or ATMPs highly valued.
Knowledgeof microbiological, virological, and analytical QC methods (plaque assays,qPCR, sterility, endotoxins, purity, identity, genomic analyses).
Familiaritywith ICH Q2, GMP, Ph. Eur., EMA/FDA guidelines, and CMC principles.
Experiencein equipment and method qualification/validation and management of outsourcedtesting.
Strongorganizational, analytical, and problem-solving skills.
Excellentcommunication and cross-functional collaboration abilities.
Abilityto work independently in fast-paced, start-up environments withinitiative 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.
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.
Be part of a team that values collaboration, creativity, and mission-first thinking.
Enjoy team breakfasts, lunches, afterworks, and memorable team-building moments.
Ready to make an impact? We’d love to hear your story. Apply today!
#J-18808-Ljbffr