Industrialization Biomol Engineer

Stilla Technologies is a Life sciences company whose mission is to improve health by offering researchers and clinicians worldwide solutions for high precision genetic analysis.
Since 2016, Stilla Technologies has empowered researchers with the Naica System, a solution that enables to detect & quantity DNA with unprecedented precision.

The Naica System supports a wide range of genetic tests and molecular biology assays — including liquid biopsy tests for cancer diagnostics, viral load quantification, pre‐natal testing, and GMO detection. Overall, the Naica System’s superior performances make it a preferred technology for precision medicine research and therapeutic monitoring.
Stilla advises and supports its customers worldwide with a multidisciplinary team, whose expertise spans from microfluidics and chemistry, to molecular biology and computer science.

After completing a 20 M€ Series B funding round in January 2020, Stilla intends to accelerate the adoption & development of its next-generation solution to clinical diagnostics market. The company is looking to: 1. Expand the sales of its Naica System worldwide 2. Scale production capacities 3. Maintain a strong R&D pipeline of innovative products for precision genetic analysis (instrumentation, consumables and assays).

The Industrialization Engineer gets involved in all phases of product development, making sure that operational aspects are covered and anticipated prior to the transfer from R&D to Manufacturing, and takes the lead on a project during the industrialization phase. The Industrialization Engineer reports to the Director of Operations.
The Industrialization Engineer’s main missions include :

• Managing industrialization projects :
o Evaluating and selecting suppliers
o Elaborating industrial specifications based on R&D technical specifications, marketing requirements, quality and regulatory requirements, logistics, etc.
o Supervising development and industrialization phases outsourced or in-house
 Process or product optimization according to specifications
 Qualification and implementation of new methods or equipments
 Validation of prototypes or pilot batches
o Creating quality documentation associated with the product / process
o Planning and follow-up of stability studies, repeatability/reproducibility and any other study necessary to verify product performances for its regulatory registration
o Take part in the supply & quality agreement elaboration and implementation
o Ensure scientific watch on industrial processes / technologies involved for the product manufacturing

• Promoting the results achieved by :
o Sharing results through oral/written presentations, technical reports, production files, etc.
o Record innovative manipulations, results, ideas, optimizations of methods which could lead to a patent filing

• Managing the project team in a matrix organization
o Drive and coordinate team members, including R&D, Operations, Marketing/Sales and Quality Assurance resources
o Ensure an effective interaction between departments and smooth information transfer
o Manage the project using Agile methodology

Our ideal candidate:

• Has a master 2 level or engineer degree in the biomedical field, in Molecular biology or biochemistry with a specialization in medical devices development or industrialization
• Has one or more successful experiences taking part in the development and industrialization of a medical device, preferably reagents or IVD assays
• Has a good knowledge of quality & regulatory standards in the field, ex. ISO 13485, IVDD or IVDR, ISO 23640 (stability studies)
• Capacity to manage suppliers and accompany quality audits
• Team spirit, with excellent communication skills
• Is pro-active, autonomous and rigorous
• Likes to interact with multiple teams and interfaces
• Ability to manage transversally
• Must speak French and English fluently