The Opportunity:
As part of our strong and dedicated team, you will play a key role in Bactolife’s QA/QC function, contributing to the development of our Quality Management System (QMS). In this role, you will help ensure compliance with all relevant regulatory and customer requirements and act as a Quality representative in selected Bactolife projects.
You will support the Quality function by coordinating and administering workflows and data flows related to Bactolife’s registration dossiers, as well as assisting with batch release activities. In addition, you will engage with CROs, CDMOs, and CMOs as we transfer, scale up, and monitor analytical methods and production processes.
This is an exciting opportunity to contribute to groundbreaking science and make a tangible impact on global health within a collaborative and mission-driven environment.
Overview of Bactolife:
Bactolife is a biotech company pioneering a new era in proactive healthcare through our Binding Protein™ technology, a revolutionary category of functional proteins that neutralizes harmful metabolites and enhances gut resilience. Binding Proteins are discovered and designed based on natural camelid immunoglobin fragments and upscaled through precision fermentation enabling stable and affordable supply. Their differentiated offering is well positioned in the fast-growing nutraceuticals space, meeting an un(der)served demand for innovation and capitalizing on strong consumer and customer desirability for scientifically proven specialty ingredients. Our proprietary Binding Proteins are science-backed, highly stable, and versatile ingredients designed to selectively bind and neutralize harmful microbial activities and metabolites in the gut, without disrupting the beneficial microbiome. This breakthrough approach supports gut microbiome resilience and offers a unique solution for a wide range of applications, from dietary supplements to functional food and beverages. Backed by leading investors including Novo Holdings, Athos, and the Gates Foundation, Bactolife is creating real impact worldwide with game-changing Binding Proteins for superior gut protection, made available and affordable to many.
Since 2017, we have grown into a diverse team of approx. 50 colleagues made up of specialized scientists, fermentation experts, and business developers from around the globe, representing 15 nationalities. This diversity fosters a strong team culture rooted in respect for each other’s ideas, approaches, and perspectives. As we grow, Bactolife remains committed to a culture of knowledge-sharing and continuous learning, empowering individuals through responsibility.
Our headquarter is located at Rønnegade 8, 2100 Copenhagen Ø, conveniently close to both S-train and metro connections.
Key Responsibilities:
- Help define and implement quality standards and procedures across QA, QC, Manufacturing, and the Pilot Plant
- Coordinate analytical testing (internal and external) for dossier registration and product release
- Manage CMOs, CROs, and service providers on key quality matters such as method transfer, raw material approval, and non-conformities
- Support and conduct audits and inspections
- Build and maintain Bactolife’s Quality Management System (QMS), including SOPs and non-conformity handling systems
- Define requirements for Pilot Plant approvals and certifications (e.g., food grade, ISO 22000)
- Train staff on quality and food safety practices
- Drive continuous improvement across quality systems and processes
Qualifications & Skills:
- Bachelor’s or Master’s degree in Food Science, Pharmacy, or a related field
- 3+ years of experience in a quality role within food, feed, or pharma
- Strong quality mindset with knowledge of regulatory and customer requirements; experience with HACCP or ISO 22000 is a plus
- Practical experience with QA tasks such as SOP review, batch release, CAPA, and audits
- Independent and organized, with the ability to manage multiple priorities
- Detail-oriented, proactive, pragmatic and an excellent communicator
- A true team player who thrives in a fast-paced, innovative environment
- Fluent in English, both written and spoken
Further Information:
Additional information may be obtained from Director, QA/QC Sandra Casani, sdc@bactolife.com.
