Alaya.bio is a preclinical-stage biotech company pioneering a new generation of lentiviral-vector-based polymeric nanoparticles applied to the rapid and universal in situ manufacturing of CAR T-cells.
Founded in July 2022 and based in Paris and New York, Alaya.bio is backed by industry leaders and investors with long track-records in cell therapy. The potential of our universal in situ CAR T technology has been recognized by the closing of five partnerships with renowned players in the clinical development of these groundbreaking therapies.
As part of our continuous growth, we are looking for a highly enthusiastic and talented Formulation Associate Scientist/Scientist to join our CMC (Chemistry, Manufacturing and Controls) team. This role will focus on the manufacturing, optimization and scale-up of high-quality grade batches of our lead targeting nanoparticles.
The position is located in Paris area.
Key Responsibilities
- Execute internal nanoparticle manufacturing activities, including bioconjugation, nanoparticle assembly (microfluidics) and downstream operations (Tangential Flow Filtration and sterile filtration), following rigorous batch manufacturing protocols.
-
Perform quality controls and biophysical characterization assays for batches of lentiviral vector-based targeting polymeric nanoparticles dedicated to in vitro and in vivo functional studies.
-
Ensure rigorous batch documentation, traceability and manufacturing report completion, while contributing to batch tracking and identification/investigation of deviations.
-
Participate in the optimization, robustness assessment and scale-up of nanoparticle manufacturing process units compatible with the industrialization of the bioprocess and in agreement with quality by design principles.
-
Perform a variety of biochemical (analytical HPLC (UV/RI), SDS-PAGE, SPR/Biacore) and biophysical (DLS, NTA) characterization assays.
-
Contribute to the development and implementation of relevant analytical and quality control methods alongside the optimization of the bioprocess.
-
Conduct stability studies to support formulation and process optimization.
-
Collaborate with external partners and sub-contractors with whom the company has chosen to work with. Willing to travel in the EU and US to partner sites for nanoparticle manufacturing and tech transfer activities.
-
Collect, analyze and interpret experimental data using appropriate software including electronic lab notebooks (Benchling).
-
Support day-to-day laboratory operations, including reagents and consumables purchasing, maintenance of equipment, management of biological & chemical wastes.
-
Comply with company regulatory, health and safety procedures and standards.
-
Writing of technical documents including SOPs, batch records, experimental protocols and study reports.
-
Participation in the dissemination of the company's scientific results (scientific articles, communications at international conferences)
Your Profile
- Engineer, MSc or PhD in Formulation, Nanobiotechnology, Biochemistry, Bioengineering or Biomanufacturing/Process development.
-
Proven track-record in the manufacturing of nanoparticle-based products and the associated characterization is requested.
-
Hands-on experience in polymer and/or protein chemistry, biophysical methods (DLS, NTA) and analytical HPLC is requested.
-
Strong background and technical expertise with process unit operations such as microfluidics, Tangential Flow Filtration, sterile filtration or lyophilization.
-
Additional knowledge in the improvement of GMP-compatible bioprocess units is a plus.
-
Excellent communication and interpersonal skills, with the flexibility and adaptability required to collaborate effectively across cross-functional teams, including close interaction with biologists as end users of the nanoparticles.
-
Ability to work in a rigorous and traceable experimental environment, meet deadlines, and prioritize work on multiple projects.
-
Proficiency in English (written and spoken) is essential, given the international exposure of the company.
-
Good command of IT (equipment specific software, Benchling,…) and data analysis tools (GraphPad Prism).
